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Health Technology Assessm

ent 2006;Vol. 10: No. 33

Com

puterised cognitive behaviour therapy for depression and anxiety update

Computerised cognitive behaviour therapy for depression and anxietyupdate: a systematic review and economic evaluation

E Kaltenthaler, J Brazier, E De Nigris, I Tumur, M Ferriter, C Beverley, G Parry, G Rooney and P Sutcliffe

Health Technology Assessment 2006; Vol. 10: No. 33

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Computerised cognitive behaviourtherapy for depression and anxietyupdate: a systematic review andeconomic evaluation

E Kaltenthaler,1* J Brazier,1 E De Nigris,1 I Tumur,1

M Ferriter,2 C Beverley,1 G Parry,1 G Rooney1 andP Sutcliffe1

1 School of Health and Related Research (ScHARR), University of Sheffield, UK

2 Department of Research and Development, Nottinghamshire HealthcareNHS Trust, Rampton Hospital, Woodbeck, UK

* Corresponding author

Declared competing interests of authors: none

Published September 2006

This report should be referenced as follows:

Kaltenthaler E, Brazier J, De Nigris E, Tumur I, Ferriter M, Beverley C, et al.Computerised cognitive behaviour therapy for depression and anxiety update: a systematicreview and economic evaluation. Health Technol Assess 2006;10(33).

Health Technology Assessment is indexed and abstracted in Index Medicus/MEDLINE,Excerpta Medica/EMBASE and Science Citation Index Expanded (SciSearch®) and Current Contents®/Clinical Medicine.

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ISSN 1366-5278

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Objectives: To evaluate computerised cognitive behaviourtherapy (CCBT) for the treatment of anxiety, depression,phobias, panic and obsessive–compulsive behaviour(OCD). The software packages to be considered includeBeating the Blues (BtB), Overcoming Depression: a fiveareas approach, FearFighter (FF), Cope and BT Steps.Other packages or programmes incorporating CCBT werealso considered. Data sources: Electronic databases from 1966 toMarch 2004. Evidence submitted by sponsors forCCBT products. Review methods: A systematic review was performedto identify all studies describing trials of CCBT. The cost-effectiveness assessment included a review of theliterature and the evidence submitted by sponsors foreach of the products. A series of cost-effectivenessmodels was developed and run by the project team forthe five CCBT products across the three mental healthconditions.Results: Twenty studies were identified in the clinicaleffectiveness review. The analysis of these resultsshowed some evidence that CCBT is as effective astherapist-led cognitive behaviour therapy (TCBT) forthe treatment of depression/anxiety and phobia/panicand is more effective than treatment as usual (TAU) inthe treatment of depression/anxiety. CCBT alsoappears to reduce therapist time compared with TCBT. When reviewing cost-effectiveness studies, only onepublished economic evaluation of CCBT was found.This was an economic evaluation of the depressionsoftware BtB alongside a randomised controlled trial(RCT), which found that BtB was cost-effective againstTAU in terms of cost per quality-adjusted life-year(QALY) (less than £2000), however it containedweaknesses that were then addressed in the cost-effectiveness model developed for the study.

The results of the model for the depression softwarepackages in terms of incremental cost per QALYcompared with TAU and the chance of being cost-effective at £30,000 per QALY were for BtB £1801 and 86.8%, for Cope £7139 and 62.6% and forOvercoming Depression £5391 and 54.4%. Thestrength of the BtB software being that it has beenevaluated in the context of an RCT with a controlgroup. The subgroup analysis found no differencesacross the severity groupings. For phobia/panicsoftware, the model showed an incremental cost perQALY of FF over relaxation was £2380. Its positioncompared with TCBT is less clear. When modellingOCD packages, using the practice-level licence costmeant that BT Steps was dominated by TCBT, whichhad significantly better outcomes and was cheaper.However, the cheaper PCT licence resulted in theincremental cost-effectiveness of BT Steps overrelaxation being £15,581 and TCBT over BT Stepsbeing £22,484. Conclusions: The study findings are subject tosubstantial uncertainties around the organisational level for purchasing these products and the likelythroughput. This is in addition to concerns with thequality of evidence on response to therapy, longer term outcomes and quality of life. The position ofCCBT within a stepped care programme needs to be identified, as well as its relationship to otherefforts to increase access to CBT and psychologicaltherapies. Research is needed to compare CCBT with other therapies that reduce therapist time, inparticular bibliotherapy and to explore the use ofCCBT via the Internet. Independent research isneeded, particularly RCTs, that examine areas such as patient preference and therapist involvement withinprimary care.


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Abstract

Computerised cognitive behaviour therapy for depression andanxiety update: a systematic review and economic evaluation

E Kaltenthaler,1* J Brazier,1 E De Nigris,1 I Tumur,1 M Ferriter,2 C Beverley,1

G Parry,1 G Rooney1 and P Sutcliffe1

1 School of Health and Related Research (ScHARR), University of Sheffield, UK2 Department of Research and Development, Nottinghamshire Healthcare NHS Trust, Rampton Hospital,

Woodbeck, UK* Corresponding author


v


Glossary and list of abbreviations ............. vii

Executive summary .................................... xi

1 Aim of the review ...................................... 1

2 Background ................................................ 3Description of underlying health problem ...................................................... 3Current service provision ........................... 6Description of new intervention ................ 8NICE guidance on CCBT .......................... 11Software packages included in this review . 12

3 Effectiveness ............................................... 15Methods for reviewing effectiveness .......... 15Results ........................................................ 17

4 Economic analysis ...................................... 35Search and review of published literature ..................................................... 35Review of submissions ................................ 35Cost-effectiveness and cost–utility .............. 37Cost impact ................................................ 52

5 Factors relevant to the NHS ..................... 53

6 Discussion ................................................... 55Main results ................................................ 55Assumptions, limitations and uncertainties ............................................... 56Need for further research .......................... 58

7 Conclusions ................................................ 61Cost-effectiveness ....................................... 61

Acknowledgements .................................... 63

References .................................................. 65

Appendix 1 Electronic bibliographic databases searched ..................................... 71

Appendix 2 Other sources consulted ........ 73

Appendix 3 Search strategies used in the major electronic bibliographic databases .... 75

Appendix 4 Economic evaluations, quality of life and economic models methodologicalsearch filters used in Medline (Ovid) 1966 to March 2004 ............................................ 79

Appendix 5 Excluded studies .................... 81

Appendix 6 Evidence tables fordepression/anxiety and phobia/panic studies ......................................................... 85

Appendix 7 OCD studies .......................... 135

Appendix 8 Calculated effect sizes ............ 145

Appendix 9 Transition matrices ................ 149

Appendix 10 Health state utility values .... 151

Appendix 11 Costs of interventions, methods and results ................................... 157

Appendix 12 Parameter values used in the economic models and their distributions ............................................... 161

Health Technology Assessment reportspublished to date ....................................... 169

Health Technology Assessment Programme ................................................ 183

Contents

Glossary and list of abbreviations


vii


GlossaryBibliotherapy Cognitive behaviour therapyprovided in a printed format, such as a book.

Cognitive behaviour therapy (CBT) refers tothe pragmatic combination of concepts andtechniques from cognitive and behaviourtherapies common in clinical practice.

Computerised cognitive behaviour therapyCBT delivered via a computer interface or overthe telephone with a computer-led response.The computer program is interactive, makingappropriate responses to patient input.

Homework Tasks set for patients to completein their own time. The tasks may be set eitherby the CCBT package or by the patients.

TCBT Therapist-led CBT delivered by aclinician. It can be delivered by a number ofdifferent clinically trained professionals, usingdifferent protocols and numbers of sessions,and be provided in a range of possible settings.

List of abbreviationsACQ Agoraphobic Cognitions

Questionnaire

ADIS Anxiety Disorders InterviewSchedule

AfW Assembly for Wales

AIC academic in confidence

AR applied relaxation

ASQ Attributional Style Questionnaire

ATQ Automatic ThoughtsQuestionnaire

BAI Beck Anxiety Inventory

BAT Behavioural Assessment Test

BDI Beck Depression Inventory

BHS Beck Hopelessness Scale

BSQ Body Sensations Questionnaire

BtB Beating the Blues

CACBGT computer-augmented behaviouralgroup therapy

continued

Technical terms and abbreviations are used throughout this report. The meaning is usually clear fromthe context, but a glossary is provided for the non-specialist reader. In some cases, usage differs in the

literature, but the term has a constant meaning throughout this review.

viii

List of abbreviations continued

CACBT computer-augmented behaviouraltherapy

CASP Critical Appraisal SkillsProgramme

CAVE Computer-aided VicariousExposure

CBGT cognitive behaviour grouptherapy

CBT cognitive behaviour therapy

CCBT computerised cognitive behaviourtherapy

CEAC cost-effectiveness acceptabilitycurve

CESDP Center for Epidemiologic StudiesDepression Scale

CGI clinician global impression

CI confidence interval

CIDI Composite InternationalDiagnostic Interview

CMHT community mental health team

CORE-OM Clinical Outcomes in RoutineEvaluation – Outcome Measure

CRI Coping Responses Inventory

CSAG Clinical Standards AdvisoryGroup

df degrees of freedom

DSM-IV Diagnostic and Statistical Manualof Mental Disorders-IV

EQ-5D EuroQol 5 Dimensions

ES effect size

ESb between-group effect size

ESEMeD European Study of theEpidemiology of MentalDisorders

ESw within-group effect size

FF FearFighter

FQ Fear Questionnaire

FU follow-up

GAD generalised anxiety disorder

GHQ General Health Questionnaire

HADS Hospital Anxiety and DepressionScale

HAM-D Hamilton Rating Scale for (or HRSD) Depression

HUI Health Utility Index

ICD-10 International Classification ofDiseases-10

IPT interpersonal therapy

ITT intention-to-treat

IVR interactive voice response

LGE live graded exposure

MA Managing Anxiety

MADRS-SR Montgomery Åsberg DepressionRating Scale

MI Mobility Inventory forAgoraphobia

NA not applicable

NHS EED NHS Economic EvaluationsDatabase

NICE National Institute for Health andClinical Excellence

NR not reported

continued

Glossary and list of abbreviations


ix


List of abbreviations continued

ns not significant

NSF National Service Framework

OCD obsessive–compulsive disorder

ODIN Overcoming Depression on theInternet

OHE HEED Office of Health EconomicsHealth Economic EvaluationsDatabase

OPCS Office of Population Censusesand Surveys

PASA Purchasing and Supply Agency

PCT primary care trust

PD panic disorder

PDT psychodynamic therapy

PGI patient global impression

PMR progressive muscle relaxation

PSA probabilistic sensitivity analysis

PT Phobic Targets

PTSD post-traumatic stress disorder

QALY quality-adjusted life-year

QOLI Quality of Life Inventory

QWB Quality of Well-Being

RCT randomised controlled trial

SASS Social Adaptation Self-EvaluationScale

SCID Structured Clinical Interview forDSM-IV

SD standard deviation

SF-12 Short Form 12

SF-36 Short Form 36

SPQ, SQ Spider Questionnaire

SRI serotonin reuptake inhibitor

SSRI selective serotonin reuptakeinhibitor

ST supportive therapy

SUDS Subjective Units of Distress Scale

TA treatment acceptability

TAR technology assessment report

TAU treatment as usual

TCA tricyclic antidepressant

TCBT therapist-led cognitive behaviourtherapy

TCS Treatment Credibility Scale

TH treatment helpfulness

TLP Therapeutic Learning Program

WARS Work and Adjustment Rating Scales

WLC waiting list control

WSA Work and Social Adjustment

YBOCS Yale–Brown ObsessiveCompulsive Scale

All abbreviations that have been used in this report are listed here unless the abbreviation is well known (e.g. NHS), or it has been used only once, or it is a non-standard abbreviation used only in figures/tables/appendices in which case the abbreviation is defined in the figure legend or at the end of the table.

NoteConfidential information was removed from this version of the report but was considered by the appraisalcommittee of the National Institute for Health and Clinical Excellence.

Executive summary


xi


BackgroundDepression, anxiety, phobias and panic arecommon mental disorders usually treated within aprimary care setting. Obsessive–compulsivedisorder (OCD) is less common but, as with theother disorders, is associated with considerableoccupational and interpersonal impairment.Medication is usually the first treatment offered,but is often associated with side-effects. There issubstantial evidence to support the use ofcognitive behaviour therapy (CBT) in thetreatment of these disorders. However, access islimited owing to too few therapists, expense,waiting lists and patients’ reluctance to entertherapy. Computerised cognitive behaviourtherapy (CCBT) is a self-help option that offerspatients the potential benefits of CBT with lesstherapist involvement.

Description of proposed serviceThis report evaluates CCBT for the treatment ofanxiety, depression, phobias, panic and OCD.

ObjectiveThe overall aim of the review is to update theNational Institute for Health and ClinicalExcellence (NICE) guidance on the clinical andcost-effectiveness of CCBT delivered alone or aspart of a package of care compared with currentstandard treatments for depression and anxiety(including phobias). In addition, OCD will beincluded in this review. The software packages tobe considered include Beating the Blues (BtB),Overcoming Depression: a five areas approach,FearFighter (FF), Cope and BT Steps. Otherpackages or programs incorporating CCBT willalso be considered. More specifically, the review ofCCBT aims to:

● evaluate clinical effectiveness in terms ofimprovement in psychological symptoms

● evaluate effectiveness in terms of interpersonaland social functioning

● evaluate effectiveness in terms of quality of life● evaluate effectiveness in terms of preference,

satisfaction and acceptability of treatment

● evaluate cost-effectiveness in comparison withcurrent standard treatments

● estimate the possible overall cost in Englandand Wales.

MethodsClinical effectivenessA systematic review of the literature was performedto identify all studies describing trials of CCBTdelivered either alone or as part of a package andeither via a computer interface or over thetelephone with a computer-led response. Databaseswere searched from 1966 to March 2004.

Cost-effectivenessThe cost-effectiveness assessment was in two parts.The first was a review of the literature and theevidence submitted by sponsors for each of theproducts. The second was the development ofcost-effectiveness models of the five productsacross the three mental health conditions.

ResultsNumber and quality of studiesClinical effectivenessTwenty studies (including two academic inconfidence) met the inclusion criteria fordepression/anxiety and phobia/panic, ten of whichincluded software packages and ten were otherstudies of CCBT. With regard to the includedsoftware package studies, four of the ten were RCTs.Of the ten other studies included in the review, ninewere RCTs and one was a pseudorandomised trial.An additional two studies of CCBT as a treatmentadjunct for therapist-led cognitive behaviourtherapy (TCBT) were also identified.

Four studies of CCBT for OCD were identified,two of which were randomised controlled trials(RCTs), and all of which were studies of theincluded package, BT Steps.

Cost-effectivenessThe review of published studies identified oneeconomic evaluation of CCBT. The only relevant

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study was also included in the submission ofUltrasis for BtB. This was a cost-effectivenessanalysis undertaken alongside a randomisedclinical trial of BtB compared with treatment asusual (TAU). This study was well conducted andhad good internal validity. It estimated the costper quality-adjusted life-year (QALY) to be £1250.However, the assumed cost of intervention wasbased on unrealistically high throughput numbers,the derivation of QALYs was weak and the trialwas limited to 8 months.

The other packages only submitted informationon the costs of their products and this was used inthe economic modelling.

Evidence of effectivenessClinical effectivenessDepression/anxietyTen studies of CCBT for depression were includedin this review, six of the included softwarepackages and four other studies. Three studies ofBtB were included, two for Cope and one forOvercoming Depression. Two of these were RCTs.One found BtB to be more effective than TAU.Both the Cope studies and the OvercomingDepression study had no comparator, but showedimprovement in symptoms of depression frombaseline.

Four other studies of depression were included inthis review, three of which were RCTs and one waspseudorandomised. Two studies compared CCBTwith an information website. One found CCBT tobe ineffective, and one found both to be effective.The fourth study compared CCBT with a waiting-list control and found CCBT to be effective.

Phobia/panicTen studies of CCBT for phobia/panic wereincluded in this review, including four for FF. Ofthese four, two were RCTs, one showing both FFand TCBT to be effective and both more effectivethan relaxation. The other FF RCT compared FFwith another CCBT package and found bothCCBT packages to be effective. The other two FFstudies were non-randomised studies. Onecompared CCBT with an historical cohortreceiving TCBT and found both to be effectiveand the other compared two delivery methods ofFF (Internet versus clinic computer) and foundthat both groups improved.

With regard to the six other studies included forphobia and panic, all were RCTs. Three of thesestudies showed CCBT to be more effective than awaiting-list control, somewhat less effective than

relaxation and slightly less effective than TCBT.Of the final three studies, of Computer-aidedVicarious Exposure (CAVE) for treatment of spiderphobia, one found both three and six sessions ofCCBT to be effective, the second found TCBT(single session) to be more effective than CCBT(single session) and a waiting-list control, and thefinal study showed CCBT, TCBT and relaxation tobe effective.

OCDFour studies of OCD, all for BT Steps, wereincluded in the review. One of these was an RCTusing TCBT and relaxation as comparators. Inthis trial, TCBT was significantly more effectivethan BT Steps, although both groups improvedsignificantly from baseline and both were moreeffective than relaxation. In the other RCT,schedule support was more effective than on-demand support. Finally, in the two non-comparative trials less than half of patients whocompleted treatment using BT Steps improvedfrom baseline.

Therapist timeThree studies gave no information regardingtherapist time. Two studies reported no directcontact, with all contact being via the Internet,and the other studies reported from 5 minutes to115 ± 44 minutes.

Cost-effectivenessCost-effectiveness models were constructed of thefive products. These models were based partly onsponsors’ submissions, but also on the advice oflocal experts and using evidence on key parametervalues (such as throughput, utility values andcosts) from other published sources. The resultsare presented as a series of incremental cost perQALY ratios and associated cost-effectivenessacceptability curves for each product under arange of purchasing scenarios.

DepressionThe three products share the same basic modelstructure of a decision tree model comparing twoarms: CCBT and TAU over an 18-month period.The BtB model was able to use the individual levelresults of the RCT and simply extend the benefitsby another 10 months by making assumptionsabout relapse rates taken from the literature onCBT. The costs of the intervention were estimated using more realistic assumptions about likely throughput than the submission. For practice-based licences, the overallintervention costs per patient were £219.30 forBtB, £195.86 for Cope (with practice-provided

Executive summary

Internet access and £170.30 without) and £72.64for Overcoming Depression. For PCT-basedlicences the costs fell to £104.62, £110.53 and£66.64, respectively.

The results in terms of incremental cost per QALYcompared with TAU and chance of being cost-effective at £30,000 per QALY for BtB were £1801 and 86.8%, for Cope were £7139 and£62.6%, and for Overcoming Depression were£5391 and 54.4%. It is difficult to compare acrossproducts, given that there have been no head-to-head comparisons and the main clinical studieswere undertaken on different populations.However, the strength of BtB lies in the fact that it has been evaluated in the context of anRCT with a control group. For this reason there isless uncertainty around the cost-effectiveness of BtB. The subgroup analysis found nodifferences in cost-effectiveness across the severity groupings.

[Commercial-in-confidence information has beenremoved.]

Phobia/panicFF was compared with TCBT and relaxation.TCBT is equivalent to standard therapist-led CBTand was designed to consist of six hourly sessions.Relaxation involved around 1 hour of contact timewith a trained behavioural therapist. Theeconomic model is a four-cycle discrete-stateMarkov model lasting for 12 months and eachcycle length is 3 months. The overall interventioncost of FF was £195.86 (with practice Internetaccess and £171.30 without) and £110.53 for aprimary care trust (PCT) licence. The incrementalcost per QALY of FF over relaxation was £2380.Its position compared with TCBT is less clear.Although one trial found TCBT to be moreeffective than FF, this difference was neithersignificant nor consistent across outcomemeasures. Assuming that this was a significantdifference, the incremental cost per QALY ofTCBT over FF was £17,608, but the probability ofbeing cost-effective at £30,000 per QALY was just61%. The main limitations of this model are thatthe effectiveness results were based on a smalltrial, the linkage of outcome to QALYs wasindirect and the assumed throughput levels wereuncertain.

OCDCost-effectiveness was assessed using a decisiontree model with three arms: BT Steps, TCBT andrelaxation. TCBT consisted of 11 weekly 1-hoursessions to negotiate self-exposure homework.

Relaxation therapy patients were asked to performrelaxation exercises on a daily basis for 10 weeks.The intervention cost of BT Steps per patient hasbeen estimated to be £837.23 for a practice-basedlicence with practice access to the Internet and£719.49 with no access to the Internet in generalpractice. A PCT licence is much cheaper at£248.83, assuming that it can achieve the samelevels of throughput per practice. Using thepractice-level licence cost meant that BT Steps wasdominated by TCBT, which had significantlybetter outcomes in one trial and was cheaper.However, the cheaper PCT licence resulted in BTSteps costing less than the more effective TCBT.At the lower cost the incremental cost-effectivenessof BT Steps over relaxation was £15,581 and ofTCBT over BT Steps was £22,484. The cost-effectiveness of BT Steps depends crucially on the licence and the throughput achieved perlicence.

ConclusionsClinical effectivenessThere is RCT evidence to support theeffectiveness of BtB and FF. There is no RCTevidence for Cope and Overcoming Depression.Evidence from the one RCT of BT Steps suggests that it is less effective than TCBT, but patients improved significantly from baseline.

● There is some evidence that CCBT is aseffective as TCBT for the treatment ofphobia/panic.

● There is some evidence that CCBT is moreeffective than TAU in the treatment ofdepression/anxiety.

● In studies reporting accurate estimates oftherapist time, CCBT appears to reducetherapist time compared with TCBT and istherefore of use where access to TCBT islimited.

● CCBT is not as effective as TCBT in OCD.

Cost-effectivenessReviewsThere was only one published economicevaluation of CCBT, which was an economicevaluation of BtB alongside an RCT. It concluded that BtB was cost-effective against TAU in terms of cost per QALY (less than £2000).It had a number of weaknesses that wereaddressed in the model. The submissionscontained some cost data, but no other cost-effectiveness studies.


xiii


Executive summary

xiv

DepressionThe results in terms of incremental cost per QALY compared with TAU and the chance ofbeing cost-effective at £30,000 per QALY for BtB were £1801 and 86.8%, for Cope were £7139 and 62.6% and for Overcoming Depressionwere £5391 and 54.4%. The strength of BtB lies inthe fact that it has been evaluated in the context ofan RCT with a control group. The subgroupanalysis found no differences across the severitygroupings.


Phobia/panicThe incremental cost per QALY of FF overrelaxation was £2380. Its position compared withTCBT is less clear.

OCDUsing the practice-level licence cost meant thatBT Steps was dominated by TCBT, which hadsignificantly better outcomes and was cheaper.However, the cheaper PCT licence resulted in theincremental cost-effectiveness of BT Steps overrelaxation being £15,581 and TCBT over BTSteps being £22,484.

These conclusions are subject to substantialuncertainties around the organisational level forpurchasing these products and the likelythroughput. This is in addition to concerns withthe quality of evidence on response to therapy,assumptions about longer term outcomes andquality of life.

Recommendations for researchFurther research priorities include the following:

● The position of CCBT within a stepped careprogramme needs to be identified, as well as itsrelationship to other efforts to increase access toCBT and psychological therapies.

● Research is needed to compare CCBT withother therapies that reduce therapist time, inparticular bibliotherapy.

● Further research is also needed to explore theuse of CCBT via the Internet.

● Research needs to be carried out byindependent researchers. Research should becarried out by those who are not associated withcommercial or product gains.

● Studies of CCBT should be RCTs and need toinclude an intention-to-treat analysis to takeinto account patients who drop out of trials.The reasons for withdrawal from trials need tobe identified as these relate directly to patientpreference.

● Patient preference should be addressed in thetrial design. Two possibilities are the inclusionof qualitative research methods and the use ofpatient preference trials.

● Research is needed to determine the level oftherapist involvement needed when usingCCBT programs to produce optimal outcomes.

● Studies need to be undertaken within the GPsetting, as this is where most patients withanxiety, depression and phobias are treated.

● Efforts should be made to include patients withco-morbidities routinely treated within primarycare.

The overall aim of the review was to update the National Institute for Health and

Clinical Excellence (NICE) guidance on theclinical and cost-effectiveness of computerisedcognitive behaviour therapy (CCBT) deliveredalone or as part of a package of care as compared with current standard treatments fordepression and anxiety (including phobias). Inaddition, obsessive–compulsive disorder (OCD)was included in this review. The software packages to be considered include Beating theBlues (BtB), Overcoming Depression, FearFighter(FF), Cope and BT Steps. Other packages orprograms incorporating CCBT were also

considered. More specifically, the review of CCBTaimed to:

● evaluate clinical effectiveness in terms ofimprovement in psychological symptoms

● evaluate effectiveness in terms of interpersonaland social functioning

● evaluate effectiveness in terms of quality of life● evaluate effectiveness in terms of preference,

satisfaction and acceptability of treatment● evaluate cost-effectiveness in comparison with

current standard treatments● estimate the possible overall cost in England

and Wales.


1


Chapter 1

Aim of the review

Description of underlying healthproblemAt any one time approximately one in six peopleof working age has a mental health problem, mostoften anxiety or depression.1 Most people withmental health problems who seek help are caredfor by their GP together with the primary careteam. For every 100 individuals who consult theirGP with a mental health problem, nine will bereferred to specialist services for assessment andadvice or for treatment.1

The Office of Population Censuses and Surveys(OPCS) Psychiatric Morbidity Survey (1995)2

found prevalence rates (per 1000 population) formixed anxiety and depression of 77 in Englandand 70 in Wales, for generalised anxiety disorder(GAD) of 31 in England and 40 in Wales, for adepressive episode of 21 in England and 24 inWales, and for panic disorders of nine in Englandwith no data reported for Wales. For all phobias,prevalence rates were 11 for England and ten forWales. Prevalence rates for OCD were 11 forEngland and 26 for Wales. Estimates in Britain forcommunity prevalence of anxiety disorders are5%, with over two million sufferers. However, onlya small minority actually undergo treatment.3

DepressionDepression is associated with long suffering,suicide, occupational impairment and impairmentin interpersonal and family relationships.4 It hasbeen estimated that up to 50% of attenders atprimary care level present with some symptoms of

depression, although depression is oftenundiagnosed.5 Patients may not seek treatment fordepression for several reasons, including failure torecognise symptoms, underestimation of theseverity, limited access to services or reluctance tosee a mental healthcare specialist because ofstigma. Patients may be unwilling to comply withtaking medication or to comply with psychologicaltherapies and for these reasons may also not seektreatment. GPs may not diagnose up to 50% ofdepression or anxiety disorders, particularly wherethe patient complains of somatic rather thanpsychological symptoms.6

There are two main depressive syndromes, majorand minor.7 A multinational study of depressionfound that the symptoms most commonlyreported from seven countries were insomnia, lossof energy and thoughts of suicide for majordepression.8 Table 1 shows the criteria for a majordepressive episode. A minor depressive episode, incontrast, is diagnosed when a patient has onlythree or four of the symptoms described in Table 1.

Two comprehensive guides frequently used for thediagnosis of mental disorders are the Diagnosticand statistical manual of mental disorders (DSM-IV),10

and the International statistical classification ofdiseases and related health problems – 10th revision(ICD-10).11 DSM-IV was developed by theAmerican Psychiatric Association, while the ICD-10 is the comparable European guide fordiagnosis of mental disorders. Both are used bypsychiatrists, psychologists, social workers andother mental healthcare providers to understand


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Chapter 2

Background

TABLE 1 Diagnostic criteria for a major depressive episode9

1. Depressed mood or2. Loss of pleasure or interest3. At least four (or three if both 1 and 2 are present) additional symptoms:

● Increase or loss of appetite or significant weight gain or loss when not trying to lose weight● Insomnia or hypersomnia● Psychomotor retardation or agitation (observable by others)● Fatigue or loss of energy● Feelings of worthlessness or excessive/inappropriate guilt● Diminished ability to think, concentrate or make simple decisions● Recurrent thoughts of death, passive or active suicidal ideas

4. Duration of at least 2 weeks with the above symptoms being present most of the time, nearly every day5. Symptoms are distressing and/or interfere with functioning

and diagnose mental health problems. DSM-IVlists over 200 mental health conditions and thecriteria required to make an appropriatediagnosis. According to the DSM-IV, an episode ofmajor depression involves symptoms (see Table 1)being evident for at least 2 weeks. Other disorderswith similar symptoms or subtypes of majordepressive disorder include dysthymic disorder,bipolar disorder, bereavement, adjustmentdisorder with depressed mood, seasonal affectivedisorder, and postpartum depression.12

Women consistently have higher rates ofdepression than men although this changes overthe age of 55.13 However, men have higher ratesof suicide at all ages. The mean onset of majordepression is in the late twenties. Deprivation isassociated with higher prevalence rates ofdepressive symptoms in a community, withvariations in prevalence related to indices ofdeprivation.14 Although depression can occur atany point in a life cycle, many elderly patients withdepression remain untreated. In examining a largecohort of depressed elderly patients in theLongitudinal Aging Study Amsterdam, theprognosis of late-life depression in the communitywas poor.15 There is little evidence concerning theeffectiveness of treatment for elderly people inprimary care, especially in people with mild formsof depression. There is a need for studiesexamining the efficacy of non-pharmacologicaltreatment with elderly patients, since theyfrequently take more medication, which can leadto contraindications for antidepressant use.16

Depression is also associated with physical illnessand some studies have shown that healthcare costsfor depressed patients are substantially more thanfor non-depressed patients.14

Depression is associated with considerableeconomic burden. The early recognition andtreatment of depression is important, sinceresearch has shown that the prognosis fordisorders of depression is poor, with rates ofrelapse and recurrence being high.17

AnxietyAnxiety disorders are recognised as one of themost prevalent diagnostic mental disordergroups.18 Anxiety syndromes are frequent inprimary care and are associated with a clinicallysignificant degree of severity and substantialpsychosocial disability.19 The OPCS Surveys ofPsychiatric Morbidity20 define generalised anxietydisorder by four criteria including durationgreater than 6 months, presence of free floating

anxiety, autonomic overactivity and an overallanxiety score of 2 or more (including heart racing,hands sweating, feeling dizzy and difficulty gettingbreath). Panic is diagnosed when criteria forphobic disorders are not met and the patient hashad recent panic attacks, is anxiety free betweenattacks and has an overall panic score of 2 or moresymptoms (frequency, duration and severity ofsymptoms are used in scoring).20

Symptoms of depression and anxiety more oftenthan not coexist.14 Studies of the prevalence ofdepression and anxiety disorders have shown thatthere is a high prevalence of co-morbidity of thesetwo disorders.8 One study of over 20,000individuals in the USA18 found 47.2% of thosemeeting lifetime criteria for major depression tohave also met criteria for a comorbid anxietydisorder. 25.6% had a lifetime prevalence ofsimple phobia, 20.4% had agoraphobia, 13.6%had social phobia, 13.0% had panic disorder and14.4% had OCD.18 The average age of onset ofany lifetime anxiety disorder (16.4 years) andsocial phobia (11.6 years) among those with majordepression was much younger than the age ofonset for major depression (23.2 years) and panicdisorder.

Recognition of anxiety disorders by GPs is oftenpoor and the proportion of patients who receivetreatment is low. There are several well-definedanxiety disorders, the most frequent beingagoraphobia, panic disorder and generalisedanxiety disorder.19 Women are more likely thanmen to develop anxiety disorders.21

Epidemiological studies suggest that women havea two to three-fold increase in the occurrence ofpanic disorder and GAD.21

One UK study22 found the lifetime prevalence ofpanic to be 8.6% and well over half of this sampleof 1000 patients had single or multiple additionalpsychiatric diagnoses. The amount of perceiveddisability suffered by individuals with panic isconsiderable.

PhobiasPhobias are separated by the OPCS PsychiatricMorbidity Survey20 into four categories:agoraphobia without panic disorder, agoraphobiawith panic disorder, social phobias and specific(isolated phobias). All four categories arediagnosed if social impairment is present, ifavoidant behaviour is a prominent feature and ifthere is an overall phobia score of 2 or more(scoring includes feeling nervous and anxious withthe symptoms such as heart racing, hands

Background

4

sweating, feeling dizzy and difficulty gettingbreath, among others, and avoidance behaviour).There is often overlap between panic and phobias,with many people suffering from both. There isalso considerable co-morbidity between disorderssuch as agoraphobia and panic disorder withdepression.14 Panic and agoraphobia alone form aconsiderable mental health burden, being the fifthmost common problem seen in primary caresettings.23 Phobias frequently have their onsetearly in life and are considered to be risk factorsfor later development of major depression andalcoholism.24 One study of phobias found thatsimple phobias often involve multiple fears.24 Themost prevalent specific fears identified in thisstudy were of animals for women and of heightsfor men.

Many people avoid the panic associated with theirphobias through avoidance behaviours, which canhave a considerable impact on their quality of life.One study of social phobia found that people withsocial phobia reported low functioning on theQuality of Well-Being (QWB) scale anddissatisfaction with many aspects of life.25 Socialphobia contributes to early behavioural difficultiesand decreased academic performance, potentiallyleading to lower educational attainment andincome.26 Rates of reported lifetime prevalence ofsocial phobia range from 0.5% to 16.0%.26

Changes in the diagnostic criteria have resulted inincreased estimates in more recent years.Variations in prevalence rates may also be due tothe use of different survey instruments andmethods used to identify cases.

Obsessive–compulsive disorderOCD is classified as an anxiety disorder, but wasnot included in the previous review as it isclinically quite distinct from the other anxietydisorders. DSM-IV (1994)10 defines obsessions asrecurrent and persistent thoughts, impulses orimages that are intrusive and inappropriate, andthat cause marked anxiety or distress.Compulsions are repetitive, purposeful andritualistic behaviour or mental acts, performed inresponse to obsessional intrusion, to a set ofrigidly prescribed rules. The behaviour must beaimed at reducing distress or preventing somefeared outcome, and to reach criteria for OCD,the symptoms must impair a person’s occupationor social life and cause significant distress.

OCD is a heterogeneous syndrome, which overlapswith both anxiety and mood disorders.27 Theprevalence of OCD varies according to age and

gender, with around 50% of patients having onsetin childhood or adolescence.28 Six-monthprevalence rates have been estimated at 1.5%, witha lifetime prevalence of 2.2–3%.29,30 UntreatedOCD has a long duration with low 1-year recoveryrates.

Since OCD is characterised by neuropsychiatricsymptoms that involve many functions (e.g.language, thought, memory and movement), it islikely that several cerebral regions are involved inthe psychophysiology of this complex disorder.27

Advances in neuroimaging techniques havesuggested that an underlying dysfunction in OCDmight be linked to the prefrontal cortex–basalganglia–thalamic circuit, rather than to one brainregion.27

A large variety of medications is used to treatOCD. Serotinergic agents [selective serotoninreuptake inhibitors (SSRIs)], includingclomipramine, have been found to be effectivecompared with other antidepressants; the specificinvolvement of serotonin [5-hydroxytryptamine (5-HT)] in the pathophysiology of OCD has beenproposed.27 Relapse rates are high whenmedication is discontinued.31

Behavioural treatment for OCD involves exposureto whatever evokes obsessions and preventsavoidance or neutralisation of the resultinganxiety [exposure and ritual or responseprevention (ERP)]. An example would be thepatient touching something felt to becontaminated with germs, then refraining fromrepeated hand washing. Over time, the levels ofanxiety and discomfort are reduced. Cognitivemethods have been combined with behaviouraltreatment, for example to combat compulsiverumination with thought-stopping. Cognitivetherapy aims to correct the obsessional thoughts(such as exaggerated sense of harm and personalresponsibility) by Socratic questioning, logicalreasoning and hypothesis testing. Cognitivetherapy can also challenge the negative automaticthoughts associated with the obsessions.

The success of combining pharmacological andbehavioural treatment for OCD ranges between 30and 50% improvement in symptoms in 50–85% ofpatients, although some residual symptoms arecommon.32 One quantitative analysis of therelative efficacy of behavioural andpharmacological treatments provided inconclusiveresults,33 but additional studies have found ERP tobe highly effective at reducing OCD symptoms.34

Cognitive therapy appears to be an effective


5


adjunct to ERP in the treatment of intrusivethoughts and ruminations, and in the preventionof relapse.35

Current service provisionAs stated previously, the majority of peopleidentified with depression are treated in theprimary care setting. Drugs prescribed in primarycare are usually either tricyclic antidepressants(TCAs) or SSRIs. However, antidepressants areoften associated with unwanted effects such as drymouth, drowsiness, blurred vision, constipation,urinary retention and sweating for TCAs, andgastrointestinal effects, anorexia andhypersensitivity reactions among others forSSRIs.36 This can result in poor compliance. Asthere is a stigma attached to the use ofantidepressants some patients may be hesitant touse them. Benefits are not immediately apparentand can take several weeks to occur. Patients arealso often unaware of the necessity for continuedtreatment over several months.

Some psychological therapies have been found tobe as effective as antidepressants in treating mildto moderate depression. These include cognitivebehaviour therapy (CBT), problem-solvingtherapy, psychodynamic-interpersonal therapy andinterpersonal therapy.14

Treatments recommended for anxiety includeCBT, antidepressant drugs, relaxation and othercoping strategies and behaviouralpsychotherapy.37 Panic disorders also benefit fromCBT. Recommended treatments for phobiasinclude combinations of cognitive treatments andexposure treatments.37 SSRIs are considered bymany to be the drug of choice in social phobia.38

In the OPCS Surveys of Psychiatric Morbidity inGreat Britain,20 one in eight people with aneurotic disorder was receiving treatment. Amongthis group two-thirds were taking medication andhalf were having either therapy or counselling.Patients classified as having two or more neuroticdisorders were three times more likely to havereceived some form of treatment than those withone disorder (30% compared with 10%). In theOPCS survey the groups most likely to bereceiving treatment were those classified as havinga phobia (28%) or a depressive episode (25%).Those least likely to be receiving treatment werethose with mixed anxiety and depressive disorder(9%). For patients with one or more neuroticdisorders receiving treatment, 39% received

psychotherapy or psychoanalysis, 2% received sex,marital or family therapy, 2% received art, musicor drama therapy, 5% received social skillstraining, 51% received counselling and 2%received behaviour or cognitive therapy. Therefore0.24% of all patients with a neurotic disorderreceive either behaviour or cognitive therapy.

Although many patients with depression wouldprefer psychological therapy to drug treatment,14

the huge demand for these services compared withthe resource of trained staff available means thatthey are not available to the majority of patients.Not all GPs possess the skills for mental healthwork, so services must often be obtainedelsewhere. Finally, GPs may not be enthusiasticabout the appropriateness of mental healthservices for patients and may therefore not referpatients who might benefit from these services.GPs interviewed for the Clinical StandardsAdvisory Group (CSAG) study, concerned with thetreatment of depression in the primary caresetting in the UK, reported that NHSpsychological therapy services had waiting lists ofas long as 18 months for some therapies. Waitingtimes for appointments with mental healthspecialists providing sessions in primary care weregenerally shorter, ranging from 2–3 weeks to up to3 months.14 The very long waiting lists may meanthat this treatment is simply not available to themajority of patients. There is also often a lack of clear referral criteria and referral pathwaysfrom primary care to specialist mental healthworkers.14 As with many mental health services,the provision of psychological therapy is patchy,uncoordinated, idiosyncratic, potentially unsafeand not fully integrated into managementsystems.39

The National Service Framework (NSF) for MentalHealth1 was developed to determine models oftreatment and care for adults of working age up tothe age of 65 years living in England. The NSF forMental Health defines national standards formental health, what they aim to achieve, how theyshould be developed and delivered and howperformance should be measured. Standard 2 ofthe NSF for Mental Health states that any serviceuser who contacts their primary healthcare teamwith a common mental health problem shouldhave their mental health needs identified andassessed and be offered effective treatments,including referral to specialist services for furtherassessment, treatment and care if they require it.Standard 3 states that any individual with acommon mental health problem should be able tomake contact round the clock with the local

Background

6

services necessary to meet their needs and receiveadequate care, and be able to use NHS Direct, asit develops, for first level advice and referral on tospecialist helplines or to local services.

The House of Commons Select Committee onHealth40 investigated the delivery of generalmental health services and the implementation ofthe NSF. The report states that there is clearevidence that there are considerable shortages inkey mental health professions and that the NSF isunlikely to become a reality unless these shortagesare addressed. One of the service gaps highlightedas currently inadequate was talking treatmentssuch as counselling, psychodynamicpsychotherapy, interpersonal psychotherapy andcognitive therapy (including CBT) on the NHS.Although the report identified a shortage ofpsychologically based treatments in the NHS,there was little evidence to determine whether thiswas due to a shortage of professionals, a lack ofawareness among those responsible for purchasingmental health services as to their benefits, or cost.More research in this area is recommended.

NICE is in the process of producing guidelines forthe management of depression in primary andsecondary care41 and the management of panicdisorder and GAD.42 Both of these guidelines werepublished in December 2004. A guideline forOCD was published in November 2005.

Cognitive behaviour therapyCBT is a psychotherapy commonly practised inthe NHS. CBT refers to the pragmaticcombination of concepts and techniques fromcognitive and behaviour therapies common inclinical practice.2 The behaviour component ofCBT is structured to solve problems and relievesymptoms by changing behaviour and theenvironmental factors that control behaviour.Graded exposure to feared situations is one of the most common behavioural treatmentmethods and is used in a range of anxietydisorders. Self-exposure therapy is exposuretherapy that is administered by the patient, whoexposes him or herself to situations of increasingdifficulty. It is often used in the treatment ofphobias.

The cognitive therapy component of CBT is also astructured approach. Techniques such aschallenging negative automatic thoughts andbehavioural techniques such as activity schedulingand behavioural experiments are used with themain aim of relieving symptoms by changingmaladaptive thoughts and beliefs.2 Relaxation

training and social skills training are also used inCBT.43

The NSF for Mental Health states that CBT andinterpersonal therapy have been found to beefficacious in the treatment of depression.2 CBThas been identified as a major component ofprimary and secondary mental healthcare services.The NSF for Mental Health proposes nationalstandards guided by ten principles, includingservice user involvement and evidence-basedinterventions.44 There is strong evidence that CBTis effective in specialist settings, but the resultsfrom general practice have been equivocal.45 Arandomised controlled trial (RCT) comparedtreatment with non-directive counselling, CBT andusual GP care for patients with depression.45 Thestudy found counselling and CBT to be equallyeffective and superior to usual GP treatment forboth depression and mixed anxiety/depression at4 months. By 1 year the usual GP care groupimproved to be equivalent to the other twogroups. Patients at 1 year expressed higher levelsof satisfaction with the non-directive counsellingtreatment.

In another RCT of CBT, CBT was compared withimipramine, their combination or placebo for thetreatment of panic disorder.46 Combiningimipramine and CBT appeared to confer limitedadvantage over imipramine alone acutely, butmore advantage by the end of the maintenancephase. Each treatment worked well immediatelyfollowing treatment and during maintenance.CBT improvements remained durable in thefollow-up phase.

A recent systematic review of brief psychologicaltreatments for depression47 included CBT as wellas interpersonal therapy (IPT), psychodynamictherapy (PDT) and supportive therapy (ST). Theauthors concluded that some forms of briefpsychological treatments, particularly thosederived from cognitive/behavioural models, werebeneficial in the treatment of depression outsidehospital settings.

A meta-analysis of treatment outcome for panicdisorder48 examined the effectiveness ofpharmacological, cognitive behavioural andcombined pharmacological and cognitivebehaviour treatments in 43 controlled studies thatincluded 76 treatment interventions. Cognitivebehavioural treatments yielded the highest meaneffect size (ES = 0.68) relative to the othertreatments. Dropout rates were also found to belower for CBT: 5.6% relative to 19.8% in


7


pharmacological treatments and 22% in combinedtreatments. Studies were selected on the basis thatthe patients had panic disorder with or withoutagoraphobia, and the studies used a control groupand had random assignment to treatment. Studiesthat compared multiple or combination treatmentswere included as long as they had a control.

CBT is also effective in treating anxiety disorderswith marked symptomatic anxiety (panic disorder,phobias and GAD).2 In another RCT, patientsmeeting the criteria for GAD were randomised toCBT, analytical psychotherapy or anxietymanagement training.49 In this trial, CBT wasfound to be significantly more effective thananalytical psychotherapy. Anxiety managementwas also significantly more effective, although atfollow-up CBT improvement was superior.

The Evidence Based Clinical Practice GuidelineTreatment choice in psychological therapies andcounselling states that common therapy length forCBT in the NHS is from eight to 20 sessions.2

Therapy length of fewer than eight sessions isunlikely to be optimally effective for mostmoderate to severe mental health problems.2

Often 16 sessions or more are required forsymptomatic relief. Recommendations from theguideline are that patient preference shouldinform treatment choice, particularly where theresearch evidence does not indicate a clear choiceof therapy. The skill and experience of thetherapist should also be taken into account. Morecomplex problems and those where patients arepoorly motivated require the more skilfultherapist.2

Two recent papers50,51 have challenged thetraditional length of time needed to obtain benefitfrom CBT. The RCT reported in these paperscompared three groups: standard therapist contactof 6 hours, minimal therapist contact of 3 hoursand bibliotherapy in 104 patients. The standardtherapy group showed the greatest treatmentefficacy, even though therapy was of notablyshorter duration than the usual recommendedlength of therapy. There was significantly greaterimprovement in the standard treatment groupcompared with the bibliotherapy group on all end-point measures and on some end-pointmeasures in the reduced therapy group.

In common with all psychological therapies, thereare problems in the delivery of CBT, including toofew therapists, expense, waiting lists and patients’reluctance to enter therapy. As stated previously,only 0.24% of patients with a neurotic disorder

receive either behaviour or cognitive therapy.20

There have been calls for therapists to rethink the traditional emphasis on 9–5 working hours,face-to-face sessions, hourly appointments andappointment systems run through outpatientwaiting lists,44 as this approach does not currentlymeet patient needs. At present there appears to beinsufficient evidence available on the cost-effectiveness of CBT in comparison to alternativeapproaches to the management of depression.52

Description of new interventionCCBT is one of several self-help therapies thataim to offer CBT to patients while using reducedamounts of therapist times. Stepped care is oneapproach in which a variety of self-help options isoffered to appropriately screened patients.

Self-help therapiesThere are currently problems with access to goodmental healthcare due to staff shortages, patchyservices, poor coordination between services andlong waiting lists. Recent developments inpsychological treatments have included problemsolving, psychoeducation and self-help. Theseprovide an alternative to the traditional therapist-led treatments.

Recent literature concerning the treatment ofanxiety disorders using self-help, self-administeredand minimal-contact interventions has shown thatself-administered treatments seem most effectivefor motivated patients seeking treatments withsimple phobias.53 Minimal-contact therapies havedemonstrated efficacy for a large number ofanxiety diagnoses (e.g. specific phobia). Self-helptherapies also appear efficacious for mild tomoderate depression and anxiety disorders.54

Problem solving is a simple treatment that can beimplemented by primary care staff, usuallyinvolving six sessions of treatment. Training isdelivered to nurses in as little as four half-daysessions. Techniques include problem definition,choice of achievable goals, finding solutions andevaluation. There is evidence that problem solvingcan be of benefit in major depression.55,56

Psychoeducation involves eight weekly 2-hoursessions. The techniques include information,changing thoughts, activities and relaxation.Training includes a 2-day course, practice group,video assessment, follow-up meetings and ongoingquality control. Psychoeducation may be aseffective as problem solving.55,56

Background

8

Self-help is used to describe the use of materials todeliver treatment in a medium-based format suchas via books, audiotapes or videotapes orcomputers, and used by an individual for self-treatment.57 Self-help usually forms an adjunct totherapy or may be a standalone treatment.

A recent systematic review of self-help treatmentsfor anxiety and depression found that theavailable evidence is limited in both quantity andquality.58 The review concludes that thesetreatments may have the potential to improve theoverall cost-effectiveness of mental health serviceprovision.

BibliotherapyBibliotherapy is one form of self-help involvingminimal contact with a therapist. It usually takesthe form of cognitive behaviour methods in awritten format. Bibliotherapy is a self-administered therapy. It has been used for treatingdepression and anxiety.58,59 Several studies haveshown the efficacy of this treatment with a rangeof ages from children to older adults.60

Self-administered treatments, when used across avariety of disorders, seem more effective incomparison to no treatment.58,61 Further researchhas shown that bibliotherapy, in comparison totherapist-administered treatments, is moreeffective for certain problems (assertion training,anxiety and sexual dysfunction) than for others(weight loss, impulse control and studyingproblems).62

Four meta-analyses of self-help59,62–64 found thatthey are as effective as therapist-led cognitivebehaviour therapy (TCBT). Self-help treatmentsappear to be most effective for skills-deficittraining and the treatment of anxiety, depressionand sexual dysfunction. In the meta-analysis ofbibliotherapy for unipolar depression, it was foundto be an effective treatment modality, and no lesseffective than either individual or group therapy.59

With regard to additional therapist input, thereappears to be little effect on patient outcome overself-help alone.62–64 However, anxiety treatmentsdo appear to be more effective when there isadditional therapist contact.62 Self-helpapproaches are not suitable for patients notinterested in using self-help, those with severe ormajor depression, and patients with visual,hearing or reading difficulties.57

The evidence on self-help therapies is limited andat present there is little evidence to suggest thatone approach may be more effective than another.

A recently completed trial assessed the use of self-help therapies in primary care.54 This RCT, calledPsychological Health Assessing Self-HelpEducation in Primary Care (PHASE), was amulticentre study in the UK and compared the useof a self-help booklet based on CBT techniquesand facilitated by practice nurses with ordinarycare by GPs for mild to moderate anxiety anddepression. The self-help intervention consisted ofup to three appointments, two 1 week apart andthe third 3 months later. Outcomes of interestincluded Clinical Outcomes in Routine EvaluationOutcome Measure (CORE-OM), EuroQol-5Dimensions (EQ-5D), patient satisfaction andcost. In the intention-to-treat (ITT) analysis,patients treated with the self-help interventionattained similar clinical benefit for similar costs,but reported more satisfaction than those treatedwith ordinary GP care. Patients in the self-helpgroup were more than twice as likely to achievereliable and clinical change at 1 month comparedwith the ordinary care group, but this differencehad disappeared by 3 months. Patients in the self-help group were also less likely to be referred toother services than those in the GP group.

Another trial, Self-Help in Anxiety and Depression(SHADE), involved the use of facilitated self-helpusing a manual with additional support fromassistant psychologists in primary care settingswithin a stepped care framework. Preliminaryresults of this trial are now published.65

A Dutch RCT of patients with subthresholddepression explored the effects of minimal contactpsychotherapy in primary care on the occurrenceof new cases of major depression.66 The authorsreport that 1 year after baseline, the incidence ofmajor depressive disorder was significantly lowerin the psychotherapy group compared with thosereceiving usual care.

Finally, a survey of CBT therapists’ attitudestowards structured self-help materials67 found thatself-help materials were used by 88.7% oftherapists who responded to the survey. The self-help materials were usually used as a supplementto individual therapy and delivered in paper-based formats.

Stepped careStepped care is a model of healthcare delivery thathas been applied to a range of disorders.68 Instepped care, more intensive psychologicaltreatments are reserved for those patients who donot benefit from the simpler initial treatments.Results of treatments and provision are monitored


9


and changes made if current treatments are notachieving significant health gain. Stepped careprogrammes need to include careful monitoring ofpatients to prevent at-risk patients being put intotreatment steps that are ineffective and potentiallydangerous. Stepped care models have thepotential to improve the efficiency ofpsychological therapy provision.68

To facilitate the implementation of a NationalEnhanced Service for depression the followingmodel of stepped care has been proposed.17 Afterappropriate initial assessment, the clinical pathwayfor stepped care in this model involves five steps.Patients enter at different steps depending onseverity and previous history. Within steps thereare choices for patients regarding type oftreatment. Each patient has scheduled contacts toassess progress. Step 1 is watchful waiting. Step 2involves four options: guided self-help, CCBT,group psychoeducation, exercise on prescriptionand signposting (assisting the patient in findingappropriate local or national voluntaryorganisations). Step 3 involves two choices: briefpsychological therapy and medication. Step 4involves chronic disease management principles ofdepression (such as assigning a case manager,provision of medication and/or psychosocialinterventions, proactive management of thepatient, feedback from the case manager to GPand mental health specialist) or longer term CBTor IPT. Finally, step 5 involves specialist treatment-resistant services.

Computers in mental healthcareComputers are used for a variety of purposes inmental healthcare. They can be used as adiagnostic assessment tool, for assessmentmeasures and to administer in vivo exposure, aswell as to provide treatment.69 Computers can alsobe used for monitoring patients’ progress and toprovide education to patients.70 A variety oftreatment options is possible and treatment maybe via the Internet, interactive telephones orvirtual reality systems.71 Even patients who areilliterate can have access to computers viainteractive voice response (IVR) telephonesystems.

Computerised therapy has distinct possibleadvantages.72 It allows the dissemination ofstandardised yet personalised treatments. Theprograms can be customised for each patient while still maintaining protocols in the correctsequence. Finally, the costs associated withcomputer-based treatments are potentially lessthan those associated with clinician-based

treatments. Other advantages are that they can beused 24 hours a day, 7 days a week, depending onaccess, without affecting efficiency, and they donot suffer some of the deficiencies of humantherapists such as memory problems and fatigue.73

Computer-based therapies can potentially improveaccess to treatment, promote self-monitoring, givesystematic feedback to the user and help withcoping skills, as well as provide built-in outcomemeasures.74 Privacy and consistency of care andease of data collection are other advantages.71

Computer-based therapies can be used at homemaking them particularly useful for people whoare currently unable to access care because of theirmental health problems. Other setting options forcomputer-based therapies include GP surgeries,psychiatric clinics, walk-in clinics, libraries andsupermarkets.

Fundamental requirements of computer programsin a public health system are that they are easy touse and of demonstrated effectiveness, and thatthey protect confidentiality of patient data.74

Client safety issues should be given carefulconsideration so that clinician negligence does notresult in harm to the patient.71 There is thedanger that patients are left to use the computerwith little supervision. Patient confidentiality alsoneeds to be taken into account. Recentrecommendations from the Department ofHealth75 emphasise the need for clearunderstanding of informed consent, expressconsent, public interest, anonymisation andpseudonymisation of patient information. Theseissues affect the use of computers in mentalhealthcare as patient information must remainconfidential but be accessible by professionalsinvolved in the care of the patient.

Clinician resistance may be a barrier to the use ofcomputers, as clinicians may feel supplanted. Thisapproach may not be useful for patients who arenot computer literate, although most programsare user friendly, requiring minimal computerskills. Some programs also use activation via thetelephone as opposed to keyboard. Not all patientswill be open to the idea of using a computer.Another drawback to the widespread use ofcomputer treatment programmes is that somepackages may be very expensive.

A computer-assisted therapy programmeTherapeutic Learning Program (TLP), has beendeveloped to permit individualised therapy in agroup context.76 In comparing TLP to standard

Background

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cognitive behavioural treatment in 109 patients,no significant differences were found in patientsatisfaction, effectiveness or clinician-rated patientimprovement, or on measures of anxiety anddepression. Clearly, computers and Internet-basedprogrammes are providing new advances in thepsychological assessment, treatment and cost-effectiveness.77 CLIMATE is a computer programthat uses information from clinical practiceguidelines for teaching patients about theirdisorder.78 It uses cognitive behaviour principlesto guide self-management in the treatment ofanxiety and depression disorders.

Computerised cognitive behaviour therapyAs stated earlier, CBT is an effective treatment formany psychological disorders. Owing to problemssuch as lengthy waiting lists there is a real need tofind new ways to make CBT accessible to patients.Along with the self-help approaches, such asbibliotherapy mentioned above, CCBT is apotentially useful treatment option for depression,anxiety and phobias, and involves minimaltherapist contact.

Equipment required to use CCBT includes acomputer or telephone. The type of equipmentneeded depends to a large extent on the program.At one end of the spectrum are programs availableon CDs, which can be purchased by individuals foruse on home computers. At the other end areprograms requiring designated specialisedcomputers.

Some CCBT programs are for use in GP surgeriesor libraries and some are used over the Internet.Patients may use other programs at home or inclinic or hospital settings. The personnel requiredto implement CCBT can vary from a psychiatristto a practice nurse. Therapist time needed willalso vary depending on the program. Some aredesigned to need very little input, apart from abrief introduction and monitoring from someonewith minimal training. Other programs are usedas a treatment adjunct so that patients receive thesame amount of CBT with a therapist and thecomputer treatment provides an additionaltechnique.

CCBT programs are most often developed forspecific patient groups, for example, patients withdepression or patients with phobias. Some,however, may be used for more than one patientgroup. Programs are interactive in that thecomputer makes appropriate responses to theinput received from the patients. On the basis ofthe responses, homework is often generated from

the computer sessions. Examples of availableCCBT packages include Overcoming Depression,Beating the Blues, FearFighter, Cope, BT Steps,MoodGym and ODIN. Currently, some CCBTsoftware packages are being used in certain areaswithin the NHS.

In a national survey of 500 cognitive behaviouraltherapists, of whom 329 responded (65.8%), only12 (2.4%) reported the use of computerised self-help and five (1%) reported its use as analternative to patient–therapist contact.79 Themajority saw computerised self-help as asupplement rather than as an alternative totherapist-led treatment.

NICE guidance on CCBTNICE issued guidance on the use of CCBT foranxiety and depression in October 2002.80 Therewas felt to be evidence to suggest that CCBT maybe of value in the management of anxiety anddepressive disorders, but insufficient evidence torecommend general introduction of thistechnology into the NHS. Independent researchwas recommended to explore the role of CCBTwithin stepped care, including user preferences,suitability needs and educational/culturalcharacteristics.

The following recommendations for research wereidentified:

● Clinical efficacy but not clinical effectiveness forBtB and FF has been established. Furtherinvestigation into the clinical efficacy of otherCCBT packages needs to be conducted.

● Optimum site of delivery needs to beestablished, whether primary or secondary careor dedicated centres.

● Criteria should be developed that allowidentification of the optimum CBT package(including CCBT) for individual patients.

● Research is needed to identify individuals mostsuited to CCBT in preference to other methodsof delivery of CBT.

● Processes for appropriate screening and referralfor CCBT need to be established andimplemented.

● The role and place of CCBT within steppedcare need to be established, and the use ofCCBT in conjunction with TCBT should beevaluated more fully.

● The level of facilitator involvement needed toproduce optimal outcomes for CCBT should beevaluated.


11


● Research is needed to compare the cost-effectiveness of CBT via a computerisedinterface with TCBT and usual GP care andwith a combination of these approaches.

Software packages included in thisreviewFive software packages are included in this review,three used to treat anxiety and/or depression, oneto treat phobias and panic, and one to treat OCD.

Depression and/or anxietyBeating the Blues BtB is a CBT-based package for patients withanxiety and/or depression. It consists of a 15-minute introductory video and eight 1-hourinteractive computer sessions. As described in themanufacturer’s submission, the CBT strategiesused include: identifying thinking errors,challenging automatic negative thoughts,modifying attributional style and identifying corebeliefs. The behavioural techniques used includegraded exposure, sleep management, problemsolving, task breakdown and activity scheduling.The sessions are usually at weekly intervals and arecompleted in the routine care setting (i.e. GP’spractice). Homework projects are completedbetween sessions and weekly progress reports aredelivered to the GP or other health professional atthe end of each session. These progress reportsinclude anxiety and depression ratings andreported suicidality. No minimum reading age isspecified.

CopeCope is a CBT-based system designed to helppatients with non-severe depression. It is notrecommended for patients with severe depressionor who are actively suicidal. Cope was developedby a joint UK–USA-based team as an IVR plusworkbook-based system. It is also available as anetwork version (netCope). It assumes a minimumreading age of 11 years. Patients can telephone asand when they wish.

Cope is a 3-month program with five maintreatment modules. Module 1 is an introduction tothe programme and depression. Module 2 is onassertive communication, expression of positiveand negative feelings, and practising scenarios.Module 3 is on constructive thinking and module4 is on pleasant activities. Module 5 is onconsolidating strategies and relapse prevention. Ifthe participant reports severe depression orsuicide plans the system urges them to consult

their doctor and will not allow the participant tocontinue until they and their doctor say that it issafe to continue. Suicide assessment questions areincluded and patients are urged to contact theirdoctor if suicidal ideation or plans were reported.Responsibility for reporting suicide risk appears torest with the patient.

Overcoming Depression: a five areas approachOvercoming Depression is a CD-ROM-based CBTsystem for patients with depression. A specific partof the remit of the system development was tooffer CBT in as jargon-free form as possible. Itassumes a minimum reading age of 9–12 years forall but one module.

The system consists of six sessions, each of whichtakes about 45–60 minutes to complete. Thesessions are delivered in a mixture of text, cartoonillustrations, animation, interactive text, soundand video. There is an offer of a self-help supportpractitioner (who may be a nurse) at thebeginning of each session. Sessions are completedon a weekly basis.

Phobia/panicFearFighterFF is a CBT-based package for phobic, panic andanxiety disorders. FF was originally developed forstandalone PC (standaloneFF) but was laterdeveloped for use on the Internet (netFF). It isalso available in a short version for educationalpurposes (FFeducation). FF assumes a minimumreading age of 11 years.

FF is divided into nine steps. Step 1 gives anintroduction to the system and rates theparticipant on the Fear Questionnaire (FQ), andWork and Social Adjustment (WSA) scale, and asksabout suicidal feelings and alcohol misuse. Step 2describes CBT with case examples and asksparticipants to keep a daily record of phobiatriggers. Step 3 is problem sorting, where theparticipant is asked to identify triggers for theirfears and is shown relevant scenarios. They arealso asked to rate their triggers on a 0–8 scale.Step 4 provides advice on getting a co-therapist.In Step 5 the participant sets and tests goals andrates them. The system then generates apersonalised homework diary. In Stage 6 theparticipant is shown a series of coping strategies tobe used during homework. In Stage 7 theparticipant is shown how to practise the strategiesin both imagined and live CBT homework. Stage8 reviews progress, including graphs, sets newgoals, and gives feedback and advice. Step 9 istrouble-shooting. Therapist contact for FF is brief,

Background

12

with 5 minutes before the session and up to 15minutes after each session. For netFF, therapistcontact is by telephone or e-mail.

Obsessive–compulsive disorderBT Steps As described in the manufacturer’s submission, BTSteps is designed to help patients with OCD byhelping them to plan and carry out CBT on a day-to-day basis. BT Steps was developed by a jointUK–USA-based team as a telephone IVR systemplus workbook. It assumes a minimum reading ageof 11 years. An Internet version is underdevelopment and will obviate the need for IVRand workbook. Helpline support is provided.

BT Steps is divided into nine steps. Step 1introduces BTS, CBT and how to use the IVRsystem. Step 2 teaches participants how to identifyrituals and their costs and explains CBT in moredetail. It also takes the participant through aprocess of identify their own rituals and obsessionsand then to rate themselves on the Yale–BrownObsessive–Compulsive Scale (YBOCS) and the

WSA scale. Step 3 involves the participantchoosing triggers (cues) appropriate to them froma list of commonly found triggers to rituals andobsessions. The participant is then asked to ratethe discomfort that each trigger causes. Step 4invites the participant to involve, if they wish, arelative or friend as co-therapist and takes the co-therapist through the relevant parts of theworkbook. The co-therapist is also asked to helpthe participant rate themselves on the HamiltonRating Scale for Depression (HAM-D). Step 5invites the participant to develop a first personalgoal for CBT with their first trigger for rituals andobsessions, choose and practise coping tactics,describe the difference it makes, and decidewhether a co-therapist will be used and whetherthe participant can commit the time. Step 6 isfine-tuning. Step 7 helps the participant with theCBT for each trigger and can be repeated as manytimes as necessary for many triggers. Step 8 istrouble-shooting and once again this can berepeated many times. Step 9 covers relapseprevention and the development of constructivealternatives to rituals and obsessions.


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Methods for reviewingeffectivenessIdentification of studiesSearch strategiesThe search aimed to identify all referencesrelating to the clinical and cost-effectiveness ofCCBT for anxiety and depressive disorders, withparticular emphasis on the literature publishedsince the original NICE guidance (no. 51).

Sources searchedFifteen electronic bibliographic databases weresearched, covering biomedical, health-related,science, social science and grey literature(including current research). A list of databases isprovided in Appendix 1.

In addition, the reference lists of relevant articleswere checked and various health services’ research-related resources were consulted via theInternet. These included HTA organisations,guideline-producing bodies, generic research andtrials registers, and specialist mental health sites. A list of these additional sources is given inAppendix 2.

Search termsA combination of free-text and thesaurus termswas used. ‘Population’ search terms (e.g.depression, anxiety, panic, agoraphobia, phobia,obsessive–compulsive disorder) were combinedwith ‘intervention’ terms (e.g. cognitive therapy,behavio(u)r therapy, psychotherapy, ANDcomputer, computerised, internet, computer-assisted instruction, multimedia, etc.). This wassupplemented by more specific searches on namedpackages, such as Overcoming Depression,Beating the Blues, Restoring the Balance,FearFighter, Cope and BT Steps.

Copies of the search strategies used in the majordatabases are included in Appendix 3.

Search restrictionsNo date, language, study or publication typerestrictions were applied. This is because thesearches included an additional population group(OCD) to the original NICE guidance.

Cost-effectivenessIn addition to the searches conducted above,searches were conducted in MEDLINE, EMBASE,NHS Economic Evaluation Database (EED) andOffice of Health Economic Health EconomicEvaluation Database (OHE HEED) specifically toidentify economic literature relating to anxietyand depressive disorders. The methodologicalsearch filters used are provided in Appendix 4.

Inclusion and exclusion criteriaThe following inclusion criteria were used.

● Subjects: adults with depression or anxiety withor without depression as defined by individualstudies. To include generalised anxiety, panicdisorders, agoraphobia, social phobia andspecific phobias and OCD.

● Intervention: CBT delivered alone or as part ofa package of care either via a computer interface(personal computer or Internet) or over thetelephone with a computer response includingthe following software packages: BtB,Overcoming Depression, FF, Cope and BT Steps.

● Comparators: current standard treatmentsincluding TCBT, non-directive counselling,primary care counselling, routine management(including drug treatment) and alternativemethods of CBT delivery (such as bibliotherapyand group CBT).

● Outcomes: improvement in psychologicalsymptoms, interpersonal and social functioning,quality of life, preference, satisfaction,acceptability of treatment and site of delivery.

● Study type: papers will be assessed according tothe accepted hierarchy of evidence, wherebysystematic reviews of RCTs are taken to be themost authoritative forms of evidence, anduncontrolled observational studies the leastauthoritative. Unpublished studies will beincluded. Non-RCT evidence will only beincluded in this review in the absence of RCTevidence.

● Studies from the previous review: studies fromthe previous review of the included softwarepackages will be included if they are RCTs.Previous non-RCT evidence of the softwarepackages will only be included in this review inthe absence of RCT evidence.


15


Chapter 3

Effectiveness

The following disorders did not fall within theremit of this review:

● post-traumatic stress disorder● postnatal depression● manic depression● depression with psychotic symptoms● past Tourette’s syndrome● schizophrenia● bipolar disorder● psychosis● psychosurgery● current co-morbid major depression● serious suicidal thoughts or unstable medical

conditions in the past 6 months● alcohol or substance abuse.

Figure 1 shows a summary of study selection andexclusion.

A list of excluded studies (including excludedstudies from the previous review) is provided inAppendix 5.

Quality assessment strategyQuality assessment was based on the CriticalAppraisal Skills Programme (CASP) checklist81

for RCTs, as it is user friendly and practitionerbased. The Downs and Black checklist82 was usedfor non-RCTs. Key components of the qualityassessment are listed in Appendices 6 and 7,(Tables 21, 22, 36 and 37).

Effectiveness

16

Potentially relevant studies identified and screened forretrievaln = 455OCD studiesn = 149

Total full papers screened (plus from other sources)n = 103 (7 of these from other sources)OCD studiesn = 28

Total abstracts screenedn = 120OCD studiesn = 55

Studies rejected at titlen = 335OCD studiesn = 94

Studies potentially relevantn = 39OCD studiesn = 5

Studies included in this reviewn = 13 RCTs (2 of which areacademic in confidence)7 non-RCTs (plus an additional 2studies discussed in the treatmentadjunct section)OCD studiesn = 2 RCTs, 2 non-RCTs

Studies rejected at abstractn = 17OCD studiesn = 27

Rejected full papern = 64OCD studiesn = 23

Studies excluded on the basis ofinclusion/exclusion criterian = 17OCD studiesn = 1

FIGURE 1 Summary of study selection and exclusion

Data extraction strategyAll abstracts were double read and consensus wasobtained. All data from included studies wereextracted by one reviewer and checked by asecond, using a standardised data extraction form,and any disagreements were resolved bydiscussion.

Data synthesisStudies were assessed for suitability of poolingresults with regard to populations, comparatorsoutcomes and study type. The evidence base fromthe original CCBT review was also considered.Owing to a lack of sufficient similarity regardingthese components, meta-analysis was notundertaken and the results are presented intabulated format with narrative synthesis of theresults.

Effect sizesWhere appropriate data were provided in thestudies, effect sizes were calculated for selectedoutcomes. However, it should be noted thatgreater emphasis should be placed on theconfidence intervals surrounding the treatmenteffect on the original scales of measurement. Twoeffect sizes were calculated, a within-group effectsize and a between-group effect size (e.g. CCBTversus TCBT). The within-group effect size wascalculated as the mean change over time (i.e.initial – final) divided by the baseline standarddeviation. A positive value denotes animprovement. The papers did not report standarddeviations of change in scores over time;therefore, it was not possible to divide thedifference in change scores by the standarddeviation of variability of change.

The between-group effect size was calculated asthe difference in mean changes over time between

the groups divided by the pooled baselinestandard deviations of the two groups combined.Cohen83 suggests that the standardised effect sizesof 0.2–0.5 should be regarded as ‘small’, 0.5–0.8 as‘moderate’ and above 0.8 as ‘large’. A positivevalue denotes that the first group had greaterimprovement than the second group.

ResultsQuantity and quality of researchavailable: depression/anxiety andphobia/panic studiesFor this update, 20 trials [two of which areacademic in confidence (AIC)] were identified, ofwhich 13 were RCTs and seven were non-randomised trials. The evidence tables for thesestudies are presented in Appendix 6. The OCDstudies are considered separately later in thischapter, with evidence tables in Appendix 7. Table 2 summarises the studies included in thissection on depression/anxiety and phobias/panic.Studies of included packages are identified by thename of the package in bold.

Studies from previous reviewStudies of included software packages in theprevious review are listed in Table 3. In theprevious review, three studies of BtB were reported(Proudfoot,102 Proudfoot,103 and Grime104). TheProudfoot RCT87 listed above in Table 2 for BtBwas included in the previous review; however, anadditional 107 patients have now been included.Grime was excluded from this review as allpatients were recruited via the workplace and arevised form of BtB was used to treat work-relatedproblems. As two RCTs are now available for BtBthe initial non-comparative pilot study103 isexcluded from this review.


17


TABLE 2 Summary of patient populations

Depression/anxiety studies Phobia/panic studies

Cavanagh, 200484 (non-comparative) BtB Kenwright, 200185 (non-RCT, comparative) FFKenwright, 200486 (non-RCT, comparative) FF

Proudfoot, 200487 (RCT) BtB Marks, 200488 (RCT) FFMarks, 200389 (non-comparative) Cope Schneider, 200590 (RCT) FFOsgood-Hynes, 199891 (non-comparative) Cope Carlbring, 200192 (RCT)Whitfield, 200493 (non-comparative) Overcoming Depression Carlbring, 200394 (RCT)Christensen, 200495 MoodGym Carlbring, 200496 (RCT)Clarke, 200297 (RCT) ODIN Fraser, 200198 (RCT) CAVE

Gilroy, 200399 (RCT) CAVEYates, 1996100 (pseudo-RCT) Balance Heading, 2001101 (RCT) CAVE

[Commercial-in-confidence information has been removed.]

For FF, a preliminary report of the Marks RCT88 for FF was also included in the previousreview and no new patients have since beenadded. The Shaw105 study was a report of twosmall non-comparative pilot tests (n = 17 and n =6) and is not included in this review as RCTevidence is now available.

With regard to Cope, no RCTs were identified ineither review. Therefore, the Osgood-Hynes trial91

is again included in this review. No studies ofeither Overcoming Depression or BT Steps wereincluded in the previous review.

Appendix 6 contains the evidence tables with dataextracted from the 20 studies included in thisupdate. RCTs and non-randomised trials arepresented in separate tables. Depression/anxietystudies are listed first, followed by phobia/panicstudies. Studies of the included CCBT softwarepackages are listed first within these categories,followed by other studies of eitherdepression/anxiety or phobia/panic.

Study characteristicsStudy characteristics for the 20 studies aredescribed in Appendix 6 (Tables 21 and 22).

Description of CCBTThe studies reported varying degrees of detailregarding the description of the CCBT packagesused. Studies of included packages provided cleardescriptions of their computer programs orreferenced such descriptions. These packages aredescribed in detail in the section ‘Description ofnew intervention’, p. 8. With regard to the othercomputer packages, all provided a briefdescription of the main components of theprogram, and are described in Appendix 6 (Tables 21 and 22).

Study qualityThe CASP checklist81 was used to assess thequality of the 13 RCTs, and the Downs and Blackchecklist82 was used to assess the quality of theseven non-randomised studies. These qualityassessment tools were chosen over the Jadadcriteria106 used in the first review as they were feltto be more suitable for assessing the quality oftrials of psychological therapies. Key componentsof quality assessment are listed in Appendix 6(Tables 21 and 22).

Included packages: RCTsOf the ten studies (one of which is AIC) ofincluded packages in this review, only four wereRCTs: Proudfoot87 for BtB and Marks88 andSchneider90 for FF. The CASP checklist waschosen to assess the quality of these RCTs. Fivecore components of CASP, listed in Appendix 6(Table 21), are method of randomisation, blinding,power calculations, the reporting of numbers andreasons for loss to follow-up. With regard to thefour RCTs, the method of randomisation wasreported for all four. Two studies reported blindedassessment88,90 and three reported powercalculations.87,88,90 One study90 reported numberslost to follow-up as well as reasons why patientswere lost to follow-up, and two RCTs of includedpackages reported numbers lost to follow-up andsome reasons.87,88


Included packages: non-RCTsThe quality of the non-RCTs was assessed usingthe Downs and Black checklist. The core items ofDowns and Black include presence of acomparator group and method of allocation,identification of prognostic factors and case-mix

Effectiveness

18

TABLE 3 Studies of Included software packages from the previous review

Study Software Study design Inclusion in/exclusion from this reviewpackage

Grime, 2001104 BtB RCT Work-related anxiety, depression and stress, nodiagnosis by healthcare professional: excluded

Marks, 200488 FF RCT Included in this review

Osgood-Hynes, 199891 Cope Non-comparative study Included in this review

Proudfoot, 2003103 BtB Non-comparative study Superseded by RCT evidence: excluded(pilot test)

Proudfoot, 2003102 BtB RCT Included, but with additional patients

Shaw, 1999105 FF Non-comparative study Superseded by RCT evidence: excluded(pilot test)

adjustment. Seven of the studies of includedpackages were non-randomised studies, four ofwhich had no comparator group and weretherefore of lower quality.84,89,91,93 The two non-RCTs with comparator groups involved FF, in onecase comparing with a group having clinicianguided self-exposure therapy in another setting inthe same year for whom data were available85 andin the other comparing two types of FF delivery,Internet versus standalone computer.86 Nomention was made of how allocation to treatmentwas done, apart from for Kenwright,86 in whichpatients were chosen for the Internet group owingto their inability to come to the clinic. None ofthese studies reported blinded assessment, powercalculations, descriptions of prognostic factors orany adjustment for confounding, althoughWhitfield93 compared scores for completers andnon-completers. With regard to follow-up,numbers were reported, but not reasons in any ofthe seven studies.

Other studiesTen other studies (one of which is AIC) areincluded in this review, nine of which were RCTsand one of which was a pseudorandomisedstudy.100 Method of randomisation was reported inall but three of these studies.98,99,101 In thepseudorandomised study,100 patients were assignedalternately to Balance or waiting list control(WLC). Two studies99,101 reported blindedassessment and two studies reported powercalculations.95,97 Of the ten other studies,six92,94–96,98,99 reported numbers lost to follow-upas well as the reasons why patients were lost tofollow-up, but two of these98,99 replaced dropoutswith new patients during the study. Noexplanation was given for how the new patientswere chosen. Two studies97,101 reported numberslost to follow-up but not reasons. One studyreported numbers and only some reasons.100


Other components of the Downs and Black qualityassessment, such as reporting of main outcomes,patient characteristics, description of intervention,method of recruitment and ITT analysis areprovided throughout the evidence tables.

In summary, the four RCTs of included studiesappear to be of reasonable quality whereas thenon-RCTs appear to be of considerably lowerquality as most do not include a comparator groupor they include an inappropriate comparatorgroup.

Co-therapy or medicationIncluded packagesOf the ten studies (including one AIC) involvingthe included packages, four gave no informationregarding the use of co-therapy or medicationduring the study, including BtB studies84 and twoFF studies.85,86

Other studiesIn the ten other studies (including one AIC)included in the review, two gave no informationregarding co-therapy and medication use,98,101

while two studies reported some information95,99

and the remaining six reported more extensiveinformation on co-therapy and use of medication.

ComparatorsComparators are shown in Table 4.

Included packagesFour studies of the included packages had nocomparator group, one BtB study,84 the two Copestudies89,91 and the Overcoming Depressionstudy.93 Two studies of FF compared CCBT toTCBT, one in an RCT, which also included arelaxation arm,88 and one in an uncontrolled,non-randomised study.85 One study of BtB87

compared BtB with treatment as usual (TAU). The two other FF studies compared two differentdelivery modes (internet versus standalonecomputer)86 and FF compared with a computerprogram excluding exposure.90


Other studiesThree studies96,99,101 compared CCBT with TCBT,one of which was in a prolonged single session.101

Four studies compared CCBT with TAU, three ofwhich were WLC.92,100,101 Other studies comparedCCBT with some type of placebo such as relaxationor information provision.94,95,97–99 One studycompared different numbers of sessions of CCBT.98

Sample sizeIncluded packagesAs in the previous review, samples sizes of thestudies were generally small. For the includedpackages, one study for Overcoming Depression93

had fewer than 30 patients taking part. Two studiesfor Cope89,91 and two for FF86,90 had between 30and 80 patients and four studies had over 80patients, two for BtB84,87 and two for FF.85,88



19


Other studiesAs for the sample size of the other studies, onehad a sample size of fewer than 30 participants,94

six had between 30 and 80 participants92,96,98–101

and the others had over 80 participants.95,97

Therapy detailsTables 23 and 24 in Appendix 6 describe the detailsof therapy for the 13 RCTs and seven non-RCTS.

RecruitmentIncluded packagesAll of the BtB studies84,87 recruited patientsthrough GP referral or screening with the GeneralHealth Questionnaire (GHQ). Recruitment for theCope studies was through self-referral89 and self-referral and health professional referral.91 Incontrast, referral for the Overcoming Depressionstudy93 was through consecutive referrals to aclinical psychology service. With regard to the fourFF trials, three85,88,90 used a mixture of self andhealth professional referral while one86 used self-referral only.

Other studiesFor the other studies, one trial recruited by amailshot to a random sample drawn from theelectoral register95 and other trials97 recruitedparticipants with known diagnoses from a healthscheme. One study recruited from a waiting list ofpatients referred to psychological services forfurther treatment by their GPs.100 The remainderwere self-referrals recruited via newspapers orother sources.

Number and length of sessionsIncluded packagesBtB consisted of an introductory session lasting for15 minutes and eight treatment sessions of 50minutes each. The Cope system used telephonecalls, and one Cope study89 reported a mean of 11 ± 8 calls with a total of 122 ± 83 minutes ontelephone calls. The other Cope study91 reporteda mean of 12.7 minutes for calls. OvercomingDepression used six sessions of 45–60 minuteseach. For FF, two trials88,90 consisted of sixsessions, one with two follow-up sessions. One of

Effectiveness

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TABLE 4 Comparators used in CCBT trials

Study Study type TCBT TAU Other None

BtBCavanagh, 200484 Non-comparative ✓

Proudfoot, 200487 RCT ✓

CopeMarks, 200389 Non-comparative ✓

Osgood-Hynes, 199891 Non-comparative

FFKenwright, 200185 Comparative ✓ (in separate

non-RCT cohort)

Kenwright, 200486 Comparative ✓ (FF via Internet and FF via standalone non-RCT computer)

Marks, 200488 RCT ✓ ✓ (computer-guided self-relaxation)

Schneider, 200590 RCT ✓ (computer program excluding exposure)

Overcoming DepressionWhitfield, 200493 Non-comparative ✓

Other studiesCarlbring, 200192 RCT ✓ WLC

Carlbring, 200394 RCT ✓ (applied relaxation)

Carlbring, 200496 RCT ✓

Christensen, 200495 RCT ✓ (web-based information programme and attention placebo control)

Clarke, 200297 RCT ✓ (information website)

Fraser, 200198 RCT ✓ (three sessions versus six sessions)

Gilroy, 2000107 RCT ✓ ✓ (relaxation)

Heading, 2001101 RCT ✓ (prolonged ✓ (WLC)single session)

Yates, 1996100 Pseudorandomised ✓ (WLC)

the FF studies85 reported a mean of four sessions,and the fourth FF study86 reported seven sessionsfor those accessing FF in the clinic, while theInternet group had unlimited access over a 12-week period. Sessions were reported to be 1 hourand the study reporting Internet usage found thatFF was used 16 ± 11 times over 66 ± 2.5 days.

Other studiesThe Balance system100 consisted of a 1-hoursession with 10–30 minutes debriefing, with theoption for more. Fraser98 and Gilroy99 reportedsessions of 45 minutes for CAVE, the first withthree or six sessions and the second with three,while Heading101 reported the use of a single 3-hour session for CAVE.

Christensen95 reported six sessions for MoodGym,Clarke97 reported mean and range (1–33 sessions)for ODIN, and Carlbring92,94,96 reported thenumber of modules, but not the number ofsessions. Modules may be completed in more thanone session. These studies give no informationregarding the length of sessions.

Therapist contact and backgroundTable 5 presents the results for the outcome oftherapist time. Some studies95,97 gave noinformation regarding the amount of time spentwith a therapist.

Included packagesFor BtB, one study87 reported therapist contact of80 minutes over eight sessions using a practicenurse, while the other study84 reported only 5minutes at the first computer session by a localservice receptionist or secretary.


Cope used nurse therapists and reported a meanof 46 ± 46 minutes therapist time.89 WithOvercoming Depression,93 the screening interviewwas 20–30 minutes with a total of 47.4 minutesspent on the six sessions. Screening was by aclinical psychologist with a self-help support nurseproviding the support during the sessions. For theFF studies, total therapist time ranged from 63minutes total85 to 115 ± 44 minutes total bytelephone, excluding screening.90

Other studiesFor the Balance system,100 up to 30 minutes wasspent on each patient after the single session by apsychologist. Other studies report no informationon length of therapist contact95–97 and three

studies report that all contact was via Internet/e-mail.92,94,96 Three studies98,99,101 report thattherapists were postgraduate students and werepresent for the first 5 minutes of treatment onlyand to carry out the initial assessments.

Study site, follow-up and inclusion/exclusion criteriaTables 25 and 26 in Appendix 6 describe the studysite, follow-up and inclusion/exclusion criteria ofthe included studies.

Study site and settingIncluded packagesAll studies of the included packages were carriedout in the UK, although one FF study90 hadparticipants from the UK, the USA and Canada.The BtB studies84,87 were carried out in GPsurgeries and other primary care services. TheCope studies were conducted via the telephone89,91

and the Overcoming Depression study93 wasconcluded within a clinical psychology service. FF studies were carried out within hospital-basedpsychiatric services,85,88 both at home and in aself-help clinic,86 or in a variety of settings such ashome, office, library, clinic and via the Internet.90

Other studiesThe Balance study100 took place in GP surgeriesand a research office in the UK. Six studiesinvolved home Internet use, one in Australia,95

one in the USA97 and three in Sweden.92,94,96

The three phobia studies of CAVE took place in auniversity setting in Australia.98,99,101

Follow-upIncluded packagesFor BtB, the Proudfoot study87 reports reasons forloss to follow-up, while Cavanagh84 does not.[Commercial-in-confidence information has beenremoved.] For one Cope study89 some reasons arereported, but not all, while no reasons arereported for the other Cope study.91 ForOvercoming Depression, Whitfield93 reports noinformation regarding reasons for loss to follow-up.Of the four FF studies, two report no informationregarding reasons for loss to follow-up.85,86

Other studiesOf the remaining studies in this review, two reportno information regarding reasons for loss tofollow-up97,101 and the others report informationregarding reasons for most patients.

Inclusion and exclusion criteriaAll studies included in this review had clearlystated inclusion criteria; however, one study97 didnot report exclusion criteria. As with the previous


21


review, many exclusion criteria included co-morbidities often associated with depression,anxiety and phobias, and this has implications for the reproducibility of the results from thesestudies.


Patient characteristicsPatient characteristics are described in Appendix 6(Tables 27 and 28).

Diagnosis of disorderOnly two studies85,97 gave no information regardingthe method for diagnosing the disorder, one ofwhich was a study for FF.85 Two studies reportmethods other than a screening tool. Whitfield93

in the Overcoming Depression study reports theuse of a screening appointment with brief riskassessment. Yates100 relies on GP clinicaljudgement for diagnosis. Methods for diagnosisincluded the following:

● General Health Questionnaire (GHQ)-12

Effectiveness

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TABLE 5 Therapist time

Study Study type CCBT Comparator

Included packagesProudfoot, 2004,87 BtB RCT 80 minutes over eight sessions NR (TAU)

Cavanagh, 2004,84 BtB Non-comparative 5 minutes for first session, other No comparatortherapist time not reported

Marks, 2003,89 Cope Non-comparative 46 ± 46 minutes No comparator

Osgood Hynes, 1998,91 Non-comparative Assessment only No comparatorCope

Marks, 2004,88 FF RCT 76 ± 43 minutes Therapist 283 ± 118 minutes;relaxation 76 ± 22 minutes

Schneider, 2005,90 FF RCT 115 ± 44 per patient plus screening 87 ± 28 minutes for Managing 40 minutes Anxiety computer group

Kenwright, 2001,85 FF Comparative 63 minutes mean including 20 minutes Mean of 444 minutes (TCBT)non-RCT screening

Kenwright, 2004,86 FF Comparative 113 ± 28.1 for Internet FF users 99 ± 11.4 minutes for standalone non-RCT FF users

Whitfield, 2004,93 Non-comparative 47.4 minutes plus 20–30-minute No comparatorOvercoming Depression screening interview

Other studiesCarlbring, 200192 RCT No direct contact, 90 minutes mean NR (WLC)

for assessment, administration and e-mails, all contact via Internet

Carlbring, 200394 RCT No direct contact, 30 minutes for NR (applied relaxation)standardised e-mail messages, all contact via Internet

Carlbring, 200496 RCT NR, all contact via Internet Maximum 600 minutes (TCBT)

Christensen, 200495 RCT Weekly telephone calls by lay Information website: weekly interviewer telephone calls by lay interviewer;

attention placebo: weeklytelephone calls by lay interviewer

Clarke, 200297 RCT NR NR (information website)

Fraser, 200198 RCT 15 minutes (for three sessions) plus 30 minutes (for six sessions)assessment

Gilroy, 200399 RCT Three assessments + 5 minutes TCBT: three 45-minute sessions;relaxation: 5 minutes

Heading, 2001101 RCT Maximum of 15 minutes + assessment 3 hours (TCBT)

Yates, 1996100 Pseudorandomised Up to 30 minutes NR (WLC)

[Commercial-in-confidence information has been removed.]NR, not reported.

● International Classification of Diseases (ICD)-10

● Kessler psychological distress scale● Diagnostic and Statistical Manual of Mental

Disorders (DSM)-IV● Composite International Diagnostic Interview

(CIDI)● Behavioural Assessment Test (BAT).


Age, gender, ethnicity, background and patienthistoryAs in the previous review most studies hadconsiderably more female than male participants,apart from Whitfield93 in the OvercomingDepression study and Kenwright86 in one of theFF studies, with slightly more males, and Yates100

with equal numbers. In most studies, patients wereaged between 30 and 45 years, although mean agesand standard deviations were not always reported.Not many studies87,97–99,101 reported informationon ethnicity, with only two actually includingpatients from ethnic minorities: Proudfoot87 forBtB and Clarke.97 Five studies84,85,92,94,96 reportedno information regarding patients’ education andsocio-economic background; the others reportedat least some information.


Of the included packages, all reported informationon patient history, such as duration of symptomsand previous therapy or medication, apart fromWhitfield93 in the Overcoming Depression study.With regard to the other studies in the review,five97–101 reported no information regardingpatient history.


Baseline comparabilityInformation on baseline comparability (nosignificant difference for important variables beforetreatment) is only relevant for the comparativestudies included in the review. Of these, Proudfoot87

for BtB did not report information on baselinecomparability.

Outcomes and resultsOutcomes to be reported in this review included:

● clinical effectiveness in terms of improvement inpsychological symptoms

● effectiveness in terms of interpersonal andsocial functioning

● effectiveness in terms of preference, satisfactionand acceptability of treatment.

Improvement in psychological symptoms andinterpersonal and social functioningThe psychological symptoms and interpersonaland social functioning outcomes reported in thestudies are presented in Appendix 6 (Tables 29 and30) together with the instruments or scales used tomeasure these outcomes.

InstrumentsOutcomes on the whole related to improvement indepression and anxiety symptoms or improvementin symptoms of phobias. To measure theseoutcomes a variety of instruments was used by theinvestigators. The full range of these instrumentsis presented in Table 6. Of these instruments, theBDI, BAI, HRSD and HADS are well recognisedand frequently used scales to measure depressionand/or anxiety. Of the others, little informationwas found to recommend one over another withregard to validity and reproducibility.

● The Beck Depression Inventory (BDI) is a 21-item self-report scale used to determinedepression severity. Items are scored on a 0–3scale giving a total range of 0–63. Total scoreswithin the 1–9 range indicate minimaldepression, 10–18 mild depression, 19–29moderate depression and 30–63 severedepression.

● The Beck Anxiety Inventory (BAI) is also a 21-item self-report scale. Patients ratesymptoms from 0 to 3 according to severity. A score of 0–9 reflects normal levels of anxiety,10–18 indicates mild to moderate anxiety,19–29 moderate to severe anxiety and 30–63severe anxiety.

● The Hamilton Rating Scale for Depression(HAM-D, HRSD) is designed to be used onpatients already diagnosed as suffering from anaffective disorder of depressive type. There are17 variables measured on either a five-point ora three-point rating scale.

● The Hospital Anxiety and Depression Scale(HADS) is a self-assessment instrument formeasuring depression and anxietyindependently. It was developed for use withphysically ill patients. It is limited to 14 itemsand scored on a four-point scale from 0 to 3.

● Work and Social Adjustment (WSA) is a self-report scale of five single-item subscales: abilityto work, home management, social life, privateleisure and relationships. A sixth scale measures


23


the degree to which the problems impair theiroverall ability to lead a normal life. Each of theindices is measured by a single item Likert scaleranging from 0 to 8, with 8 indicating severeimpairment. The total score range is 0 to 40.

● The Beck Hopelessness Scale (BHS) wasoriginally developed to predict suicide risk. The scale measures negative attitudes about thefuture. It is a 20-item true/false test whichexamines three aspects of hopelessness: feelingsabout the future, loss of motivation andexpectations. It is designed for use with peopleaged from 17 to 80 years, and takes 5–10minutes to administer.

● The Social Adaptation Self-evaluation Scale(SASS) contains 21 items covering aspects ofsocial interactions, global social attitude andself-perception. It evaluates social motivation

and behaviour. The SASS is sensitive to changesin the different areas of social functioning.

● The Attributional Style Questionnaire (ASQ)measures how people perceive everydaysituations. It uses 12 scenarios with themes ofachievement or affliction. Six of the scenarioshave positive outcomes and six have negativeoutcomes. Participants are required to imaginethemselves in each situation and thendetermine the major cause of the event.

● The Fear Questionnaire (FQ) is a 20-item self-report questionnaire, on a 0–8 scale (0 = do notavoid to 8 = always avoid), about phobias anddepression. It provides scores for three types ofanxiety: agoraphobia, blood-injury phobia andsocial anxiety, plus a rating of how distressingthe anxiety is (anxiety–depression score). Aglobal phobic rating can also be derived. It is

Effectiveness

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TABLE 6 Scales used as outcome measures in included studies

Scale Abbreviation Studies used

Beck Depression Inventory and Beck Anxiety Inventory BDI, BAI Proudfoot,87 Carlbring,92,94,96 Marks,89

Whitfield93

Beck Hopelessness Scale BHS Whitfield93

Social Adaptation Self-Evaluation Scale SASS Whitfield93

Hamilton Rating Scale for Depression HRSD or Marks,89 Osgood-Hynes91

HAM-D

Phobic Targets PT Fraser,98 Gilroy,99 Heading101

Hospital Anxiety and Depression Scale HADS Yates100

Attributional Style Questionnaire ASQ Proudfoot87

Center for Epidemiologic Studies Depression Scale CESDP Christensen,95 Clarke,97

Main Problems and Goals Marks,88 Schneider90

Work and Social Adjustment scale WSA Proudfoot,87 Marks,88 Schneider,90

Cavanagh,84 Marks,89 Kenwright,85,86

Osgood-Hynes91

Work and Adjustment Rating Scales WARS Fraser,98 Gilroy,99 Heading101

Fear Questionnaire FQ Marks,88 Schneider,90 Fraser,98 Gilroy,99

Heading,101 Kenwright85,86

Body Sensations Questionnaire BSQ Carlbring92,94,96

Agoraphobic Cognitions Questionnaire ACQ Carlbring92,94,96

Mobility Inventory for Agoraphobia MI Carlbring92,94,96

Automatic Thoughts Questionnaire ATQ Christensen95

Spider Questionnaire SPQ or SQ Fraser,98 Gilroy,99 Heading101

Short Form 12, Physical Component Summary and SF-12 PCS, Mental Component Summary SF-12 MCS

Quality of Life Inventory QOLI Carlbring92,94,96

Montgomery Åsberg Depression Rating Scale MADRS-SR Carlbring96

Behavioural Assessment Test BAT Fraser,98 Gilroy,99 Heading101

Subjective Units of Distress Scale SUDS Fraser,98 Gilroy,99 Heading101

Clinical Outcomes in Routine Evaluation Outcome Measure CORE-OM Cavanagh84

General Health Questionnaire GHQ-12 Yates100

Coping Responses Inventory CRI Yates100

used with adults and takes 5–10 minutes toadminister.

● CORE-OM is a 34-item scale measuring thedomains of symptoms, functioning, well-beingand risk. The total mean score ranges from 0 to4, with a high score representing increasedproblem severity.

Results for psychological symptoms andinterpersonal and social functioning outcomesThe results for improvement in psychologicalsymptoms and interpersonal and socialfunctioning outcomes are presented in Appendix 6(Tables 31 and 32). The results for the includedpackages and other studies are described below bycomparator. Some studies are reported more thanonce owing to multiple comparators. Calculatedeffect sizes are presented in Appendix 8.

Included packagesCCBT versus TCBT Two FF studies comparedCCBT with TCBT.85,88 In the RCT,88 both the FFgroup and the therapist group improvedsignificantly from baseline. In the otheruncontrolled, non-randomised study,85 bothgroups improved significantly from pretreatmentscores; however, the TCBT group scores weremore severe at baseline.


CCBT versus TAU One of the studies of the BtBcompared CCBT with TAU in an RCT.87 CCBTsignificantly improved scores for depression,negative attributional style, work and socialadjustment compared with TAU. However, foranxiety and positive attributional style, treatmentwas found to interact with severity, so that CCBTwas significantly more effective than TAU only formore severe patients.

CCBT versus other comparisons One FF studycompared two delivery methods, internet versusstandalone computer, in a non-randomised studyand both groups improved significantly on allmeasures.86 In the other FF study,90 FF wascompared with another computer program withcognitive components but no exposure (ManagingAnxiety), both of which were delivered via theInternet. Both computer programs were equallyeffective post-treatment, but at 1 month follow-upFF was significantly more effective on somemeasures.

The FF study mentioned above88 included arelaxation group as well as TCBT. The relaxation

group had no significant improvement comparedwith the CCBT and TCBT groups in this study.

Other studiesCCBT versus TCBT Three studies96,99,101

compared CCBT with TCBT. Carlbring,96

involving patients with panic disorder (PD), foundCCBT to be effective but less so than TCBT, withresults maintained at 1-year follow-up. Gilroy99

also reports significant improvement in both theCCBT and TCBT groups for patients with spiderphobia, but more so for TCBT. Improvementswere maintained at 33-month follow-up.Heading101 compared single-session CCBT withsingle-session TBCT for patients with spiderphobia and found single-session TCBT to besignificantly more effective than single-sessionCCBT. All three of these trials were RCTs.

CCBT versus TAU/WLC Three studies92,100,101

compared CCBT with WLC. Carlbring92 foundthat participants with PD improved significantlyon most measures in the CCBT group, but not inthe WLC group. Heading101 found no significantdifference between single-session CCBT for spiderphobia and WLC. Yates100 found significantimprovement in some depression scores, but notCoping Responses Inventory (CRI) scorescompared with WLC. Two of these studies wereRCTs92,101 and one was a pseudorandomisedtrial.100

CCBT versus other comparisons Severalstudies94,95,97–99 compared CCBT with othercomparators. Of these, two studies comparedCCBT with relaxation,94,99 one of which94 foundrelaxation to be somewhat more effective thanCCBT for the treatment of PD and the other99

found relaxation to be as effective as CCBT for thetreatment of spider phobia.

One study compared CCBT with web-basedinformation sites.95 Christensen95 found that bothCCBT and web-based information groupsimproved significantly. One study comparingCCBT with TAU plus access to an informationwebsite,97 found no improvement in either theCCBT group or the web-based information groupplus TAU for treatment of depression.


Finally, one study98 compared three sessions withsix sessions of the same CCBT program for spiderphobia and found that both groups improvedsignificantly on most measures.


25


In the previous review, two studies were includedcomparing CCBT with bibliotherapy. One studyfound CCBT to be as effective as bibliotherapy108

and the other found bibliotherapy to be moreeffective than CCBT.109 No further studies wereidentified in this review.

Patient preference, satisfaction and acceptabilityThe outcomes of patient preference, satisfactionand acceptability of treatment are presented inAppendix 6 (Tables 33 and 34).

Included packagesBeating the Blues Proudfoot87 found that BtBpatients were significantly more satisfied withtreatment than TAU patients, but values were notreported. Cavanagh84 provided no information onthese outcomes.


FearFighter Marks’88 ratings of treatmenthelpfulness were reported, no significantdifferences between FF, TCBT and relaxation withregard to this outcome although FF patientstended to be more satisfied than relaxationpatients. Satisfaction ratings for Schneider90 didnot differ between FF and the Managing Anxietyprogram. Satisfaction was positively correlatedwith the outcome of the main problem. InKenwright,86 Internet users were said to begenerally satisfied, although no data werereported; three of ten Internet users said that theywould have preferred face-to-face guided self-helpto Internet-guided self-help. Kenwright85 reportedno data on these outcomes.

Cope No information was reported specificallyfor Cope in Marks;89 however, in the previousreview, in the Osgood-Hynes study,91 patientswere found to feel comfortable with the system,found it easy to use and found the bookletshelpful, while 75% of the 28 completers said that Cope had improved the quality of their lives.

Overcoming Depression All 15 respondents in theWhitfield study93 said that they would recommendthe program to others. At the end of treatment80% said that they would prefer a CD-ROM overbook treatment, 60% rated treatment usefulness as‘a lot’ and 40% as ‘a little’.

Other studiesSeveral studies reported no information regardingpatient preference, satisfaction and acceptability of

CCBT.95,97–99 Carlbring92,94 reported that mostparticipants with PD in these studies consideredCCBT to be personal, and most found it anadvantage to have treatment at home. Participantsin Carlbring92 regarded the lack of eye contact ashelpful. Most participants in Carlbring96 alsoreported satisfaction with treatment. Gilroy99

found that participants rated live exposuretherapy (TCBT) for spider phobia as moreacceptable and helpful than CCBT. Finally,Yates100 found that the overall response to theBalance programme for depression was positiveand that the programme made participants thinkin a new way about their problem.

Studies with additional informationThree studies were identified in the literaturesearches and are included here as they were felt toadd additional information regarding the deliveryand acceptability of CCBT. The first describes theuse of a questionnaire to ascertain preference forlocation of CCBT and mode of delivery. The othertwo studies are very small trials of BtB.

Graham and colleagues (2000)110

Computer-aided self-help services for OCD andagoraphobia were advertised on Teletext.Information and a questionnaire were sent out to326 people. The questionnaire covered whether ornot the respondent would access self-help if GPreferral was required, preferred mode of accessand how much they would pay for the service.Completed questionnaires were returned by 113people (35%). Of these, 27% did not want to govia their GP. With regard to mode of access, 35%preferred the Internet, 45% a telephone IVRsystem, 43% a CD-ROM at home, 23% a computerat their GP surgery, 22% a computer in their localcommunity mental health resource centre, 16% acomputer in a leisure centre, café or pharmacy,and 62% a book. Twelve per cent preferred othermodes of delivery, such as telephone support froma human therapist, audiotape, CD or video.Participants were willing to pay a mean of £10 persession (ranges 0–100).

Keaverny and Blackburn, (2004)111

The study took place in Doncaster and SouthHumber Healthcare Trust where BtB had been inplace in GP surgeries. The terminals wereremoved and recently relocated in the EastCommunity Mental Health Team. The reasons forrelocation were unclear. The aim of the study wasto determine the views of the practice leads andpractice managers concerning the implementationof BtB. Questionnaires were administered topractices that had used BtB and another

Effectiveness

26

questionnaire to practices that had not had accessto the programme.

Eighteen practices were involved, four of whichhad used BtB and 14 that had not. Responses werereceived from two of the four practices using BtBand two of the 14 not using BtB. The tworespondents who had not used BtB felt that theadvantages of the community mental health team(CMHT) were that there would be more supportand that there was not enough room in the GPsurgery.

The two respondents who had used BtB wereasked whether they were happy for the terminalsto be removed. One respondent was notconcerned and the other was happy with theremoval of the terminals. Both respondentspreferred the terminals to be in the CMHT.

Three respondents were then interviewed throughsemi-structured interview. The interviewees feltthat removal of the terminals of the CMHT gaveaccess to more people although disappointmentwas expressed as the programme had become anintegral part of the service and many patients had found it helpful and convenient based in theGP practice. Advantages of BtB were that ithelped people without using drugs, it was thought to help with positive thinking, peoplewere probably less likely to relapse, it required thepatient to do some work themselves, some peoplemay find it difficult to open up to people, costsaving with regard to staff time and immediateaccess. Perceived disadvantages were the location,high non-attendance and preference for humancontact. Many patients found it difficult to copewith the fact that it was a computer-basedprogramme; it was felt to discriminate againstthose who are older and those without IT skills. Itwas considered a disadvantage to use it in place ofa person owing to lack of funds.

Coxall and Blackburn (2004)112

This was a small study of BtB used in a secondarycare setting for anxiety and depression. Nineparticipants were recruited into the study, but onlythree completed the programme. Outcomemeasures were BAI, CORE and Millon ClinicalInventory-III (MCMI-III). The three participantsshowed symptom improvement, but this was notstatistically significant.

Studies using CCBT as a treatment adjunctNo studies of CCBT as a treatment adjunct wereidentified for the included packages. Two other

studies of CCBT as a treatment adjunct wereidentified. These are briefly described below.

Gruber and colleagues (2001)113

This study describes computer-augmentedcognitive behavioural group therapy (CACBGT)for social phobia. A preprogrammed handheldcomputer (Casio PB-1000) was used as an adjunctto cognitive behaviour group therapy (CBGT).The computer produced an audible reminder eachmorning for the participant to confront a socialfear that day. Before entering a feared socialsituation the participant started the computer,which was programmed to remind the participantof key strategies learned in the group session. Twohours after the social situation the computer againprompted the participant to start the programme,this time for a debriefing module.

At post-treatment, the CACBGT group wassignificantly better than the WLC on mostmeasures of behaviour, but there was no significantdifference on self-report. CBGT (i.e. without thecomputer) was significantly better than control onmost behavioural measures and self-report.Participants in the CACBGT reported morepositive thoughts than CBGT at post-treatment,but not at follow-up. CBGT appeared to have astronger effect than CACBGT in reducing socialphobia symptoms at post-treatment, but by follow-up both appeared equally effective.

Kenardy and colleagues (2003)114

This study describes computer-augmentedcognitive behavioural therapy (CACBT) for PD. Apreprogrammed palmtop computer (HP200LX)was programmed to signal to participants fivetimes daily to prompt practice of therapycomponents. The computer program includedmodules for self-statement, breathing control anda new exposure module for both situational andinteroceptive exposure. Twelve sessions ofconventional CBT were better in outcome than six sessions of conventional CBT, and six sessionsof CACBT were between the two in terms ofoutcome but not statistically significantly differentfrom either.

OCD studiesFour studies of OCD were included in this review,all using BT Steps, as shown in Table 7.

Study characteristicsTables 36 and 37 in Appendix 7 show the studycharacteristics for the OCD studies. Two studieswere RCTs, one comparing BT Steps with TCBTand relaxation115 and the other comparing BT


27


Steps with scheduled telephone support versus BTSteps with on-demand telephone support.116

For the randomised trials, Greist115 does notreport method of randomisation, while theKenwright study116 does. None of the four studiesof OCD used blinded assessment or reportedpower calculations and only one reported reasonsfor loss to follow-up.118 With regard to co-therapyor medication, only Bachofen118 reported noinformation. Sample sizes ranged from 23 for thenon-comparative Bachofen study118 to 218 for theGreist study.115

Therapy detailsTherapy details are described in Appendix 7(Tables 38 and 39). Recruitment was by clinicianreferral for two of the studies116,118 and a mixtureof self-referral and clinician referral for the othertwo studies.115,117 Number and length of sessionswere not clearly described in the studies, althoughBT Steps consists of nine steps and is used via atelephone. Two studies117,118 said that BT Stepswas to be used daily. Therapist contact was limitedto 15 minutes at baseline and three times duringthe study for Greist.115 In the Kenwright study,116

only three patients were screened live; all othercontact was by telephone. The professionalbackground of the therapist was not reported forany of the studies.

Therapist timeTotal mean therapist contact time was reported fortwo of the studies and ranged from 16 ± 36minutes to 99 ± 50.6 minutes.118

Study site, follow-up and inclusion/exclusioncriteriaInformation on study site, follow-up andinclusion/exclusion criteria is presented inAppendix 7 (Tables 40 and 41). One study waslocated entirely in the USA,115 although the actualsetting was not stated, and two studies werelocated in the UK, both in a clinic/hospital setting.The fourth study117 took place in two locations inthe USA and one in the UK. Length of follow-up

was reported in three of the studies,115–117 with theGreist study115 having the longest follow-up, at 26weeks after the first screening visit. Only one ofthe studies reported any reasons for loss to follow-up, although not all.118 Two of the studies reportedboth inclusion and exclusion criteria,115,117

whereas one reported inclusion but not exclusioncriteria116 and one reported neither clearly.118

Patient characteristicsPatient characteristics are presented in Appendix 7(Tables 42 and 43). Three of the four used DSM-III-R criteria for diagnosis115–117 and one usedICD-10 criteria.118 All studies had patients mostlybetween 30 and 40 years of age, although therange in Greist115 is from 15 to 80 years. All fourstudies included more or less equal numbers ofmales and females. Two reported information onethnicity, with most patients being white.115,117 Allbut one study118 reported socio-economicinformation and all but one study117 reportedinformation on patient history. The onlyinformation on baseline comparability was fromKenwright,116 who reported that types of ritualswere similar for the two groups of patients in thestudy.

Outcomes and resultsInformation on outcomes and results arepresented in Appendix 7 (Tables 44–47). All studiesused the YBOCS to measure improvement. TheYBOCS is a self-rated scale with ten items and ascore range of 0–40. It covers obsessions andcompulsions, with categories for time spent,interference, distress, resistance and control forthese. Also used were HAM-D and WSA (bothdescribed above) and the Patient GlobalImprovement (PGI) scale. Two studies included anITT analysis.115,118

In the only RCT comparing BT Steps withTCBT,115 TCBT was found to be significantly moreeffective than BT Steps, although both groupsshowed significant improvement from baseline.Relaxation was found to be ineffective. In the RCTcomparing scheduled support with on-demand

Effectiveness

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TABLE 7 OCD studies of BT Steps

Study Study type Comparators

Greist, 2002115 RCT TCBT relaxation

Kenwright, 2005116 RCT Two types of BT Steps compared: scheduled support vs on-demand support

Greist, 1998117 Non-comparative trial None

Bachofen, 1999118 Non-comparative trial None

support for BT Steps,116 the scheduled supportgroup showed greater improvement. In the non-comparative trials, Greist117 reports significantimprovement in the 17 out of 40 patients whocompleted two or more sessions and Bachofen118

reports that the ten out of the original 23 patientswho went on to use the BT Step sessions showedsignificant improvement. Calculated effect sizesare presented in Appendix 8.

Patient preference, satisfaction and acceptabilityInformation on patient preference, satisfactionand acceptability is presented in Appendix 7(Tables 48 and 49). Greist115 reports that patientswere more satisfied with clinician-guided therapythan with BT Steps. Little information is providedin the other studies; however, in an additionalreport on the Bachofen study,118 Nakagawa119

reports that patients who had received BT Stepsand then went on to clinician-guided care (n = 9)were significantly more satisfied with clinician-guided care.

Assessment of effectivenessTable 8 presents a brief summary of the clinicaleffectiveness results. Calculated effect sizes arereported here and in more detail in Appendix 8.Twenty studies were included in this review, ten ofthe included software packages and ten otherstudies of CCBT. Comparators included TCBT,TAU, WLC, relaxation and varying lengths oftreatment. Some studies used more than onecomparator.

Studies from previous reviewStudies of software packages included in theprevious review are listed in Table 3.

Beating the BluesThree studies of BtB were reported in the previousreview.102–104 The Proudfoot RCT87 listed in Table 8 for BtB was included in the previousreview; however, an additional 107 patients havenow been included. Grime104 recruited all patientsvia the workplace and a revised form of BtB wasused to treat work-related problems. In this studythere was improvement on some scores for BtB,but these were not significant at 3 and 6 months.In the initial non-comparative pilot study (n = 20),103 11 patients completed treatment andshowed some improvement from baseline.

FearFighterFor FF, a preliminary report of the Marks RCT88

for FF was also included in the previous reviewand no new patients have since been added. TheShaw study105 was a report of two small non-

comparative pilot tests (n = 17 and n = 6).Conflicting results were obtained in these studies,but some patients seemed to improve.

CopeAs no RCT evidence is available for the presentreview, the Osgood-Hynes trial91 is again included.

No studies of either Overcoming Depression orBT Steps were included in the previous review.

OCD effectiveness summaryFour trials of OCD were identified, all using BTSteps. One RCT used TCBT and relaxation ascomparators.115 TCBT was significantly moreeffective than CCBT, although both groupsimproved significantly from baseline and bothTCBT and CCBT were more effective thanrelaxation. The other RCT compared two types ofsupport, scheduled and on-demand, both usingBT Steps.116 The scheduled support group showedgreater improvement. Finally, in the two non-comparative trials,117,118 less than half of thepatients in both trials completed the BT Stepssessions and those who did showed significantimprovement from baseline.

Patient populationsThe study populations are divided into threegroups although there was some overlap.

Depression/anxietyTen studies of CCBT for depression were includedin this review, six of included software packagesand four other studies. Three studies of BtB wereincluded, two for Cope and one for OvercomingDepression. One of these was an RCT.87 Onefound BtB to be more effective than TAU.87 Boththe Cope studies89,91 and the OvercomingDepression study93 had no comparator, butshowed improvement in symptoms of depressionfrom baseline.


Three other studies of depression are included inthis review,95,97,100 two of which were RCTs andone was a pseudorandomised trial.100 Two studiescompared CCBT with an information website, onefound CCBT to be ineffective97 and one foundboth to be effective.95 The fourth study comparedCCBT with a WLC and found CCBT to beeffective on some measures.100



29


Effectiveness

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TABLE 8 Summary of clinical effectiveness

Study Study type Total Comparators Evidence for CCBTstudy size

Proudfoot, 2004,87 BtB RCT 274 TAU CCBT more effective than TAU (ESb= 0.65 forBDI)

Cavanagh, 2004,84 BtBa Non-comparative 219 None Patients improved from baselinetrial

Marks, 2003,89 Cope Non-comparative 39 None Patients improved from baseline (ESw = 1.24 trial for BDI)

Osgood Hynes, 1998,91 Non-comparative 41 None Patients improved from baseline (ESw = 1.3 Cope trial for HAM-D)Marks, 2004,88 FF RCT 93 TCBT, Both CCBT and TCBT were effective, but

relaxation TCBT was more effective (ESb = –0.04 for WSAand –0.89 for global phobia) and relaxation wasnot effective

Schneider, 2005,90 FF RCT 68 Another CCBT Both were equally effective (ESb = –0.19 for programme total phobia), but FF significantly more so at

1 monthKenwright, 2001,85 FF Historical 85 TCBT Both groups improved (ESb= –0.12 for FQ

comparative group total)Kenwright, 2004,86 FF Comparative trial 27 Internet vs clinic Both groups improved (ESb = –0.11 for

computer CCBT FQ total)Whitfield, 2004,93 Non-comparative 20 None Patients improved from baseline (ESw = 0.71 Overcoming Depression trial for BDI)Carlbring, 200192a RCT 41 WLC CCBT more effective than WLC Carlbring, 200394 RCT 22 Relaxation Relaxation somewhat more effective than CCBT

(ESb = 0.04 for BSQ)Carlbring, 2004,96 RCT 49 TCBT CCBT as effective as TCBT (ESb = –0.39 for

BSQ)Christensen, 200495a RCT 525 Information Both CCBT and information site effective

website, attention placebo

Clarke 200297 RCT 299 Information CCBT not effective (ESb = –0.05 for CESDP)website + usual care

Fraser, 200198 RCT 30 Three sessions Both groups equally effective (ESb = –0.14 vs six sessions of for BAT and 0.02 for FQ global)CCBT

Gilroy, 200399 RCT 45 TCBT, relaxation All three groups were effective (ESb = –0.42 vsTCBT and 0.95 vs relaxation for FQ global)

Heading, 2001101 RCT 40 TCBT (single TCBT more effective than CCBT and WLC session), WLC (ESb = –0.62 for TCBT and 1.01 for relaxation

for FQ global)Yates, 1996100 Comparative trial 45 WLC CCBT effective on some measures (ESb = 0.89

for HADS-D)Greist, 2002,115 BT Step RCT 218 TCBT, relaxation TCBT more effective, but both groups improved

more than relaxation (ESb = –0.45 for TCBTand 0.83 for TCBT for YBOCS)

Kenwright, 2005,116 RCT 48 BT Steps Scheduled support group showed more BT Step scheduled improvement (ESb = 0.77 for YBOCS)

helpline support vs on-demand support

Greist 1998,117 BT Step Non-comparative 40 None Those completing (<50%) had significantimprovement (ESw = 0.10 for YBOCS)

Bachofen, 1999,118 Non-comparative 23 None Those completing (<50%) had significant BT Step improvement (ESw = 0.81 for YBOCS)

a Insufficient data were provided in these studies to calculate effect sizes.ESb, between-group effect size; ESw = within-group effect size.

Phobia/panicTen studies of CCBT for phobia/panic wereincluded in this review, including four for FF. Of these four, two were RCTs, one showing FF tobe as effective as TCBT and more effective thanrelaxation.88 The other FF RCT compared FFwith another CCBT package and found bothCCBT packages to be effective.90 The other twoFF studies were non-randomised studies. Onecompared CCBT with a historical cohort receiving TCBT and found both to be effective,85 and the other compared two delivery methods of FF (Internet versus cliniccomputer) and found that both groupsimproved.86

With regard to the six other studies included forphobia and panic, all were RCTs. Three of thesestudies, by Carlbring and colleagues, showedCCBT to be more effective than a WLC,92

somewhat less effective than relaxation94 andsomewhat less effective than TCBT.96 The finalthree studies, of CAVE for treatment of spiderphobia, found both three and six sessions ofCCBT to be effective,98 TCBT (single session) to be more effective than CCBT (single session)and a WLC101 and CCBT, relaxation and TCBTto be effective, but TCBT to be more so thanCCBT.99

OCDAs described above, there were four studies ofOCD. One of these was an RCT using TCBT and relaxation as comparators.115 In this trial,TCBT was significantly more effective than BTSteps and both were more effective thanrelaxation. In the other RCT, scheduled supportwas more effective than on-demand support.116

Finally, in the two non-comparative trials,117,118

less than half of patients who completedtreatment using BT Steps improved frombaseline.

Therapy detailsAs in the last review, the amount of informationregarding therapy provided in the studies variedwidely. The number of sessions of CCBT rangedfrom one100 to nine.84,87 The length of sessionswas not always reported. The professionalbackground of the therapist varied and includednurse therapists, psychologists, practice nurses,psychiatrists, receptionists and lay interviewers.Four studies did not report therapistcontact.92,94,96,97


OCDBT Steps consists of nine steps and was to be used daily. Length of sessions was onlyreported in one study (8.6 minutes for telephonecall).115 Only one study reported therapistbackground and stated only that clinicians wereinvolved.115

SettingThe 20 studies took place in a variety ofsettings.99,100,101 Two were in primary caresettings84,87 Three were provided in a hospital orclinic setting, one for Overcoming Depression93

and two for FF.85,88,89,93 In the other two FFstudies, access was via the Internet from thepatient’s home or elsewhere.86,90 The two Copestudies were accessed via an IVR system accessedfrom the patient’s home.86,86,91

Four were in a university or research setting98–101

and others via home internet.92,94–97


OCDNone of the four BT Steps studies115–118 reportedstudy setting, as contact was via an IVR systemaccessed from the patient’s home.

ComparatorsThe results of the 20 (including two AIC) studiesare summarised as follows.

TCBTFive studies used TCBT as acomparator,85,88,96,99,115 one as a single session.101 The other studies found both CCBTand TCBT to be effective, although TCBT wasmore so, apart from in one study101 which foundTCBT to be more effective than CCBT, althoughboth TCBT and CCBT were delivered in a single session in this study. In some cases TCBTinvolved fewer sessions than might be the case inusual TCBT delivery.


TAU/WLCThree studies used a WLC as a comparator92,100,101

and one used TAU.97 Three found CCBT to bemore effective than TAU/WLC and one foundthem to be equally effective,101 although this was asingle session of CCBT. One study comparedCCBT with TAU plus an information website andfound CCBT to be ineffective.97


31



RelaxationThree studies compared CCBT withrelaxation.88,94,115 One found relaxation to be lesseffective,88 one found relaxation to be moreeffective94 and one found relaxation to be equallyeffective.99

Other comparisons included different types ofdelivery methods, another CCBT package, numbersof sessions and a web-based information website.

OCDTwo RCTs with comparator groups were presentedfor BT Steps.115,116 One found TCBT to be moreeffective than BT Steps115 and BT Steps to bemore effective than relaxation. The other RCTfound that scheduled support gave greaterimprovement than on-demand support.116

Patient preferenceFive of the 20 studies84,85,95,97,98 provided noinformation regarding patient preference,satisfaction and acceptability of treatment. Inthose studies reporting information most reportedthat participants felt positively about CCBT, apartfrom one study,99 where participants rated TCBTas more acceptable and helpful.

OCDIn one of the OCD trials,115 patients rated TCBTmore positively than CCBT.

Therapist timeSome studies gave no information regardingtherapist time.97 Two studies reported no directcontact with a therapist, all contact being via theInternet92,94 and the other studies reportedtherapist time from 5 minutes99 to 115 ± 44minutes.90

Sponsor submissionsTwo of the 20 studies described above form part ofthe sponsor submissions.84,93 Other studiespresented in the sponsor submissions aredescribed below.

Beating the BluesEighteen appendices were included with the BtBsubmission.84 These are listed below.

● Appendix 1: Proudfoot,103 included in theprevious review.

● Appendix 2: Proudfoot,102 included in theprevious review.

● Appendix 3: Proudfoot,87 included above (thiscovers the same study as Proudfoot102 plus anadditional 107 participants).

● Appendix 4: McCrone120 is an economicevaluation and is reviewed in Chapter 4.

● Appendix 5: Cavanagh84 is a non-comparativestudy of 219 patients and is included above.

● Appendix 6: Cavanagh (unpublished). Thisstudy investigates users’ reactions to the BtBpackage. It is a comparison paper to Appendix5. Participants were diagnosed as havingdepression, mixed anxiety/depression or anxietydisorder. The location was a range of primarycare settings in the UK including GP surgeries,CMHTs and primary care clinical psychologyservices, in rural and urban settings. Forty percent of participants were male. Information wascollected pretreatment on treatment credibilityand expectations and post-treatment ontreatment feedback. Two hundred and nineteenparticipants were recruited into the study, 191completed the pretreatment data collection and84 completed treatment feedbackquestionnaires. The authors’ key findings werethat participants found the treatment a positiveexperience and that pretreatment attitudes toCCBT were not predictive of continuation,attrition or outcomes.

● Appendix 7: van den Berg (published).121 Thispaper describes the introduction of BtB to asecondary care service in the UK. Attrition rateswere high, with 45% non-completers, but staffdid not consider this a wholly negative findingas non-completers included those who hadbenefited sufficiently from the early modulesand felt that they did not need to complete thefull programme. Three case studies arepresented. Case 1, a 66-year-old woman withmixed anxiety and depression, dropped outhaving felt that she had benefited sufficiently todeal with her problems. Case 2, a 53-year-oldman with mixed anxiety and depression,completed all sessions and reported that theprogramme had helped him and that he foundthe computer program easy to use. Case 3, a34-year-old woman with generalised anxiety,dropped out reporting that she found some ofthe sessions useful but did not see the point ofinteracting with a computer, with which onecould not have a conversation.

● Appendix 8: Fox (published).122 This paperdescribes the introduction of BtB to a GPpractice in the UK. The authors’ positiveobservations include that the package offeredeffective, efficient and immediate access to CBT,and that patients took a leading role in theirown therapy. The majority of the participants in

Effectiveness

32

the study responded positively to the package.Some participants found the computer program‘patronising’ and ‘condescending’ and theautomatic responses ‘offensive’ and ‘insincere’.The authors describe some of the logisticalproblems of setting up such a service in a busyGP practice and also recommend that theassistant must be knowledgeable in CBT.

● Appendix 9: Grundy (unpublished). This smallstudy evaluates the effectiveness and acceptabilityof BtB for anxiety and/or depression. Eightparticipants were randomly selected from acohort of 15 patients who had completed acourse of BtB provided by a local CMHT inWales. Participants showed a significantpre–post-treatment decrease in their HADSscore and found the package helpful and useful.

● Appendix 10: HMP Moorland (unpublished).This is a small study of seven inmates at HMPMoorland who used BtB for anxiety and/ordepression. There were improvements in self-reported anxiety and depression ratings over 8 weeks, which were statistically significant fordepression but not for anxiety. The participantsreported that the programme was ‘a little better’than other treatments, and that they were happyto use the computer and found it easy to use.

● Appendix 11: Ryden (unpublished). This studyuses data from two previous trials (reported inProudfoot87) to test whether patientcharacteristics are predictive of the effectivenessof CCBT for depression at follow-up. The totalsample size was 274 and the characteristicsincluded treatment acceptability, education,demographics, and duration and severity ofdepression. The authors found that none of thecharacteristics was a reliable predictor oftreatment outcome.

● Appendix 12: Mairs (unpublished). This is abrief report of the computer-aided therapy foranxiety and depression in a GP practice setting.Fifty-one participants began treatment and 20completed all eight sessions. There weresignificant decreases in BDI and BAI scorespretreatment to post-treatment, although datawere not provided. There were favourablecomments from both participants and GPs.

● Appendix 13: author not stated. This is a smallstudy, with eight participants, of self-help groupworkers’ reactions to the use of the package withtheir clients. All felt that BtB was a helpfulprogramme and easy to use. Five of the eightworkers thought that it would have a long-termimpact on their clients, all said that they wouldlike to see the package available in theircommunity and seven would recommend thepackage to people in their community.

● Appendix 14: Cavanagh and Shapiro(published).123 This paper contains a review ofcomputer treatment for mental disorders and ameta-analysis of treatment effectiveness fordepression. This analysis is based on data inKaltenthaler;124 however, studies have beencombined inappropriately as they includedifferent comparators, patient populations andstudy designs. A discussion of the cost-effectiveness of CCBT is also included.

● Appendix 15: author not stated. This is asingle-sheet report of a survey of healthcaresites that have used BtB. Only 37 of the 87NHS sites responded to the survey. The reportgives only limited information. User and serviceoutcomes are both described as ‘generallypositive’, with no further details.

● Appendix 16: Sawyer (unpublished). This abrief report of pretreatment and post-treatmentoutcomes for BtB offered at a tertiary CBTservice in the UK between May 2001 and April2004. In total, 333 patients (197 female) usedthe service, although data collection was variablebetween outcomes. Significant improvementswere recorded for BDI and BAI scores, self-rated anxiety and depression, and problemdistress ratings. Very few data were providedregarding details such as study population.

● Appendix 17: Clash (unpublished). Theauthors used data from a previous study, byProudfoot,102 to test the effectiveness andsuitability of the package for subgroups. This isa partial report of the ongoing study. Thecurrent findings are that participants found thepackage useful, relevant and easy to use.

● Appendix 18: Proudfoot (published).125 Thispaper is a general overview of the literature onCCBT for anxiety and depression.

BT StepsFive studies are listed in the sponsorsubmission,126 all of which are included above,apart from Marks127 which covers the same studyas Greist117 and Bachofen.118 Kenwright,116

included above, is published. BT Steps is deliveredin a telephone IVR form at present. No data wereprovided of BT Steps used in an Internet form.

CopeStudies of the clinical effectiveness of Cope listedin the sponsor submission include Osgood-Hynes,91 which was included in the first reviewand above, Gega (case studies)156 and Marks.89

Marks89 is a non-comparative trial and includedabove. All were of Cope delivered in a telephoneIVR form. No data were provided of Cope used inan Internet form.


33


FearFighterThe sponsor submission lists five studies of clinicaleffectiveness. Shaw105 was included in the previousreview. Marks88 is included above and earlyunpublished data from this trial were alsoincluded in the previous review. Kenwright86 isalso included above. FF data from Marks89 are notincluded in this review as these patients are alsopresented in Kenwright.86 Kenwright86 andSchneider90 are the only data provided on FFdelivered via the Internet.

Three appendices were included with the FFsponsor submission.

● Appendix 1: Schneider90 is included above. ● Appendix 2: Gega (unpublished) covers several

software packages. The paper describes thetesting of a screening questionnaire to detectpeople who might be suitable candidates fortreatment by CCBT. The authors conclude that,although it needs further refinement, the

screening questionnaire could be used tochannel patients with anxiety/depression toCBT or CCBT.

● Appendix 3: Mataix-Cols (unpublished) coversseveral software packages and investigatesdifferences in outcome in CCBT betweenparticipants referred from different sources:self-referrals, GP referrals and referrals frommental healthcare professionals. The majorfindings were that although all three groupsshowed improvement, the GP referralsimproved the most and the mental healthcareprofessional referrals the least.

Overcoming DepressionTwo trials are mentioned in the OvercomingDepression sponsor submission.93 One is of anongoing RCT comparing Overcoming Depressionwith a WLC group. Data on this trial wererequested and not received by the assessmentteam. The second trial is a non-comparative pilotstudy by Whitfield93 and is included above.

Effectiveness

34


35


This section is in two parts. The first is a reviewof the literature and the evidence submitted

by the sponsors for each of the products beingreviewed. The second presents in detail cost-effectiveness models of the five products across thethree mental health conditions. These modelshave been based on sponsors’ submissions, adviceof local experts and evidence on key parametervalues such as throughput, utility values and costsfrom published sources. The results are a series ofincremental cost per quality-adjusted life-year(QALY) analyses and associated cost-effectivenessacceptability curves (CEACs) for each productunder a range of purchasing scenarios.

Search and review of publishedliteratureSearches were undertaken to identify anyeconomic studies relating to CCBT. Full searcheswere undertaken using the strategies outlined inAppendix 4, which included all articles found bythe clinical effectiveness searches supplemented bysearches for economic evaluations using terms setout in Appendix 4, along with the populationsearch terms for these mental health conditions.All electronic data sets set out in Appendix 1 weresearched, including the health economicsdatabases of NHS EED and OHE HEED.

As reported in the clinical effectiveness section,the general CCBT search identified 437 articles.The economics search identified a further 17papers. Two reviewers read abstracts of all 454papers and none of them contained economicstudies. Although some did contain some relevantinformation, none met the inclusion criteria. TheBtB sponsor’s submission identified a paper thatwas not published at the start of the review, buthas since been published.120

Review of submissionsBeating the BluesThe sponsor’s submission included a paperpresenting a cost-effectiveness analysis of BtBagainst treatment as usual120 and a costing of theintervention.

Cost-effectivenessThe stated aim of the McCrone paper120 was todetermine the cost-effectiveness of CCBT using BtBcompared with TAU among primary care patientswith anxiety and/or depression. It is an economicevaluation alongside the Proudfoot RCT. Theviewpoint for the economic analysis was that of theNHS (although indirect costs were also calculated).

The CCBT intervention included the BtBpackage, with patients being allowed to receiveother forms of treatment as per usual from the GP,with the exception of face-to-face counselling orother psychological input. The TAU interventioncomprised a variety of interventions, includingdiscussions with a GP, referral to a counsellor,practice nurse or mental health professional, andtreatment of physical conditions.

The trial recruited 274 patients with anxietyand/or depression from seven general practices inthe south-east of England and randomised themto receive either CCBT (146 patients) or TAU (128patients). This trial is included in the clinicaleffectiveness review.84 Patient outcomes weremeasured using three illness-specific measures: theBeck Depression Inventory (BDI); the BeckAnxiety Inventory (BAI); and the Work and SocialAdjustment (WSA) scale. Patients completed thesescales before and after treatment, and then at 1month, 3 months and 6 months post-treatment.

The results indicated that CCBT led to greaterimprovement than TAU on all three measures.This improvement was statistically and clinicallysignificant and was sustained at the 6-monthfollow-up. BtB resulted in a mean reduction in theBDI relative to TAU of 3.5 points [95% confidenceinterval (CI) 0.6 to 6.4]. No interactions of CCBTwith concomitant pharmacotherapy or duration ofillness were found, although the authorsacknowledge that the sample size was too small torule this out.

The chosen form of economic analysis was cost-effectiveness analysis in which the data onreported clinical outcomes were combined withcost data to produce a cost per point reduction inthe BDI and a cost per symptom-free day. Acost–utility analysis was undertaken by applying a

Chapter 4

Economic analysis

utility value to days with and without symptoms.Data on resource use were collected prospectivelyalongside the trial. The costs of the BtBintervention were supplied by the sponsor (seebelow for a critical review) and other resourceswere costed using appropriate unit costs. Itcovered a wide range of NHS resource usage.Estimates were also made of the indirect costs oflost production.

Resource-use data were collected for 6 monthsbefore study entry and for the 8 month durationof the study. Complete data were available for 138CCBT and 123 TAU patients. Comparisons weremade between the mean costs of CCBT and TAUusing a bootstrapping technique to generate 95%confidence intervals. Costs were reportedseparately with and without indirect costs.

An ITT analysis revealed that the mean servicecost for CCBT was £397 compared with £357 forTAU, resulting in an incremental service cost of£40 (90% CI –£28 to £148). Total costs includinglost employment costs were less for the BtB group,at £533 compared with £900 for TAU.

Based on the BDI, the mean number ofdepression-free days was 61 (standard deviation67.1) for TAU compared with 89.7 (74.2) forCCBT over the 8 months of the trial follow-up.The figure for depression days of 0.59 was takenfrom a published review of utilities studies ofpatients with depression128 and the figure of 1.0for depression-free days was assumed. Thesefigures resulted in an estimated QALY gain of0.032. While this QALY gain was small, ittranslates into a cost per QALY of £1250.Assuming just £5 per depressed-free day resultedin a 90% chance of BtB being cost-effective.Looked at another way, valuing a one-unitimprovement in the BDI at £40 results in an 81%chance of BtB being cost-effective. The authorsconcluded that CCBT is more cost-effective than TAU.

Sensitivity analysis was carried out around the unitcost of the BtB. Lower and upper values of £50and £150, respectively, were considered. When thehigher figure was used, the cost differenceremained statistically insignificant. Justification forthe range used in the sensitivity analysis was thatthis was the range of costs that could be expectedfrom the manufacturer. No sensitivity analysis wascarried out on the other costs, such as staff costs.They also looked at a range of possible values forthe health gains, and even zero resulted in a 45%chance of being cost-effective.

This paper is the only economic evaluation ofCCBT currently available in the literature. It hasbeen carried out thoroughly and is based on awell-conducted RCT with good internal validity.Its weaknesses lie in three main areas.

One weakness is the costing for the interventionthat was given to the authors by the sponsor. Thebasis for the £100 estimate used by McCrone120 isprovided in the sponsor’s submission. A moreimportant weakness in these cost estimates is theassumed throughput levels. The cost per patientdepends crucially on the number of patientstreated by each copy of BtB each year. However,the throughput levels are based on unrealisticassumptions about the number of cases likely tocome from a typical general practice. The costingshave been modified later in this report based onmore realistic estimates of throughput at thepractice level.

The other key weakness in the McCrone120 paperis the estimation of QALYs. The authorsacknowledge that their approach was very indirect.Furthermore, it used a utility value from a studythat combined the values from a number ofdifferent published studies, using a range ofsources and methods, many of which would notmeet the NICE reference case for economicevaluation. A more direct approach has beendeveloped for the TAR model based on the BDI.

Finally, the analysis is limited to 8 months,whereas the benefits of treatment are likely to lastlonger than this. This will underestimate the likelysize of benefit and so the TAR model attempts toextend the period of benefit.

Costs of interventionThe sponsor’s costing of BtB covers more than justthe licence cost, to include hardware, capitaloverheads and clinical helper. It excludes someitems, such as training and screening, but theseare shown in the TAR costings to be comparativelysmall items. The licence fee is the largestcomponent and depends on the number of copiespurchased. For one machine the cost pertreatment was £103 in the first year and then £96in subsequent years. For six, 20 and 50 copies thecosts are £77 and £70, £60 and £53, and £56 and£49, respectively. The £100 pounds used in theMcCrone120 study may be an overestimateaccording to these figures.

To obtain a cost per patient, the sponsor assumesthat the level of throughput will be 100 patientsper practice. This assumes that around 50% of the

Economic analysis

36

capacity of a computer will be used. [Based on 30hours per week, 30 × 50 hours per year (i.e. 1500),and allowing for eight sessions plus 15 minutes’introduction for a full course of BtB. Theseassumptions result in 187 patients.] However, theassumption of 100 patients coming forward eachyear in practices of one to five GPs is based on thefollowing assumptions: average list sizes of 10,000patients; a 10% prevalence of depression; and 10%of depressed patients being treated by CCBT eachyear. There is considerable uncertaintysurrounding these assumptions.

The assumed list size is high. Practices withbetween one to five GPs have an average of threeGPs and practices of six to ten have an average ofeight GPs, which result in mean list sizes of around5000 and 14,000, respectively (General MedicalStatistics: England and Wales, 2002). Theassumption of a 10% prevalence of depression isreasonable and is similar to estimates from theONS Morbidity Survey (ONS, 2000),129 but amajor problem is that many of these do not cometo the attention of a GP.130 It is not clear whetherthe 10% prevalence figure takes sufficient accountof this problem, but the proportion of known casesmay be as low as 5%. Finally, the assumption that10% of these will take up the service is anassumption and in practice it may be verydifferent. Currently, just one in eight patients with neurotic conditions are being treated in theNHS at any point in time. The TAR modelpresented below assumes more realistic levels ofthroughput.

Cope (ST Solutions)There was no formal analysis of cost-effectivenessin the sponsor’s submission. However, the sponsorprovided useful estimates of the likely costs ofCope at different organisational levels, includingpractice with one to five GPs, practice with five toten GPs, primary care trust (PCT), strategic healthauthority, NHS Purchasing and Supply Agency(PASA) and NHS England, Wales and Scotland.

As for BtB, the licence fee is fixed at eachorganisational level so the cost per patientdepends on the number of patients likely to useeach copy. The sponsor makes the sameassumptions about the throughput for Cope as forBtB. All of the criticisms made above are relevanthere.

Overcoming Depression There was no formal analysis of cost-effectivenessin the sponsor’s submission. Indeed, thesubmission contained no cost information.

ScHARR contacted the manufacturers forinformation and were given a simple price tariff of£500 for a single general practice and £50 forsubsequent copies in a single practice. PCTspurchasing the product on behalf of theirpractices would be entitled to 20% discount onthese charges. There were no assumptions aboutlikely throughput levels.

FearFighter (ST Solutions) There was no formal analysis of cost-effectivenessin the sponsor’s submission. ST solutions providedthe same information about the likely costs of FFas for Cope.

BT Steps (ST Solutions)There was no formal analysis of cost-effectivenessin the sponsor’s submission. ST Solutions providedthe same information about the likely costs of BTSteps as for Cope and FF.

For BT Steps the throughput of treated patientswas predicted to be lower in the sponsor’ssubmission than for COPE and FF. The number ofsufferers with OCD is known to be much lowerthan depression and anxiety, at around 2%.Working this through results in 20 treated patientsper year for practices with one to five GPs and 40for those with six to ten GPs. At PCT level, it isassumed in the submission that there will be 400patients. These assumptions result in average costsper treated case of £90–250 depending onorganisational level.

As for Cope, this assumes rather large list sizes.The assumption of a 2% prevalence of OCD issimilar to estimates from the ONS MorbiditySurvey,129 but there is a problem that many ofthese do not come to the attention of a GP.130 It isnot clear whether the 2% prevalence figure takessufficient account of this problem, but theproportion of known cases may be half of this.Finally, the assumption that 10% of these will take up the service is an assumption and inpractice it may be very different. The TAR modelpresented below assumes more realisticthroughput levels.

Cost-effectiveness and cost–utilityDepression modelThe question addressed by this model is whatwould be the likely impact of each CCBT producton the costs and effectiveness of treating patientswith depression in a primary care settingcompared with TAU.


37


StructureThe three products share the same basic modelstructure. The main model is a decision treemodel comparing two arms, CCBT and TAU, overan 18-month period. CCBT is one of the productsand TAU amounts to standard care in primarycare. The latter is difficult to specify, so this modelhas used the treatment received in the Proudfoottrial87as representing TAU in the NHS. TAUpatients in this trial continued to visit their GP,receive medication and be referred to a specialist,although they were not receiving psychotherapy atthe time of entering the trial. TAU is assumed tobe the same across all three products. For BtBanother arm has been examined in the model forTCBT using the results of the trial.


The CCBT arm of the decision tree is shown inFigure 2. Patients are assumed to arrive in primarycare for treatment with either mild to moderate,moderate to severe or severe depression. Theseare widely used categories in the depressionliterature that link with existing practice and havebeen operationalised using measures such as the

BDI. The distribution between these categorieswill depend on the patients attending thepractice. The main model results are based on the distribution in the Proudfoot trial, but asubgroup analysis has been performed to examinevariation in cost-effectiveness by severity ofdepression.

Patients are given either CCBT or TAU over a 2-month period (Figure 2). A proportion of theseare assumed to complete the treatment. Patientswho comply with treatment are then assumed tobe distributed across the four depression severitycategories depending on the success of theintervention: minimal, mild to moderate,moderate to severe and severe. For BtB and TAUthe transition probabilities between the fourseverity categories before and after treatment havebeen estimated from individual-level dataprovided by McCrone120 and for OvercomingDepression from Whitfield.93 For Cope these havebeen estimated from mean values presented inpublished studies. Those who do not completeCCBT are assumed to be offered TAU and thisresults in a set of transition probabilities betweendisease severity categories achieved in theProudfoot trial.

Economic analysis

38

Minimal

Mild

Moderate

Severe

Minimal

Mild

Moderate

Severe

CCBT

TAU

Not relapse

Relapse (to mild)

Minimal

Mild

Moderate

Severe

CCBT

FIGURE 2 Partial decision tree for depression: the CCBT arm

Patients are assumed to spend 6 months in theirnew severity state following treatment. At the endof this 6-month period, which is 8 months aftertreatment began, patients who improved may staythe same or relapse. The rate of relapse in eacharm is taken from the general literature on CBT. Ifthey relapse, then at 10 months after initialtreatment they will be offered either anothercourse of CCBT or TAU in the CCBT arm. At thissecond cycle, patients are assumed to transitbetween severity categories as before over the next2 months and then stabilise for the remaining 6months of the model. If they do not relapse theystay in the post-retreatment severity category. Ifthey did not improve in the first place (they are inmoderate or severe categories) they also stay inthe same severity category.

Parameter assumptionsComplianceThe rate of non-compliance is assumed to be 30%.This is similar to the dropout rates of clinical trialsin this area and submissions on CCBT, includingthe Proudfoot trial. Although the dropouts inthese cases were often those that were lost tofollow-up for a range of reasons, one of thesewould be compliance. People who drop out fromCCBT are assumed to receive TAU.

Transition probabilitiesAs this is a decision-analytic model, it has beennecessary to define a set of health states. The BDIhas been selected for this purpose since it is theprimary outcome measure in the Proudfoot studyand has been used in studies of Cope andOvercoming Depression. It is also useful becausethere are well-established cut-offs used in theliterature relating to the BDI to the four severitycategories used in the economic model, ofminimal (≤ 9), mild (10–18), moderate (19–29)and severe (30–63).131

A crucial driver for the depression models hasbeen the rates of transitions between depressionseverity categories. For BtB these have beenestimated directly from Proudfoot trial data. Usingindividual-level data, rates of transition have beenestimated for the four depression categoriesbetween the pretreatment and 2-months post-treatment assessment. The transition matrices arepresented for BtB and TAU in Appendix 9.However, for BtB these transition probabilitieswere not used in the first cycle because analyticaldata were available. So, for the first cycle, themodel uses pretreatment mean quality of life(QoL) scores and then the actual post treatmentdistribution. The estimated transition probabilities

were, however, used for the second cycle. ForOvercoming Depression it was not possible toestimate transition probabilities because of smallnumbers.

For Cope no individual-level data were availableand so values were interpolated using the meanscores before and after treatment. Thisinterpolation involves placing a normaldistribution around the mean to estimate thedistribution of patients across the four severitycategories before and after treatment. It has notbeen possible to estimate transition probabilitiesas such, since the precise transfer of each patientwas not known. However, the numbers in eachcategory post-treatment can be estimated.

Relapse ratesIt was assumed that the relapse rate for CCBTequals the relapse rate for traditional CBT, whichwas taken from Thase.132 The relapse was definedas meeting the DSM-III-R criteria for majordepression and having a HAM-d score of 15 ormore. This article estimated relapse rates forpartially recovered patients and the relapse ratefor fully recovered patients. In the model a relapsewas defined as someone who moves down onecategory of severity. This includes someone whowas fully recovered and moved from minimal tomild or a partially recovered person moving frommild to moderate or moderate to severe. Relapserates are assumed to be the same for TAU andCCBT.

Seventy per cent of the patients who relapse afterbeing treated successfully with CCBT are assumedto have a second cycle of CCBT. The remaining30% will prefer TAU. The same rates are applied topeople who are mild after the first cycle of CCBT.

LongevityA crucial component of these models is theassumption about the longevity of any gain. Giventhat the Proudfoot study showed that theimprovements in BDI were sustained between 2and 8 months from recruitment, it can be safelyassumed that the benefits last for at least 8months. It must also be the case that a day laterthis gain has not entirely disappeared. However,the longevity of the treatment effect is not known.In this model, patients are assumed either torelapse at 8 months or to continue in their post-treatment health states for another cycle. In bothcases the model lasts for 18 months.

It should be noted that relapse has already beenincluded in the model for the first 8 months since


39


this should have been incorporated in theProudfoot data in terms of mean BDI changes.The authors accept that assuming that relapseoccurs at 8 months after treatment begins issomewhat artificial and involves some doublecounting. It is also artificial to assume no benefitat the end of the second cycle at 18 months.However, these assumptions enable some accountto be taken of the longer term benefit.

Those in the CCBT arm who relapse are assumedto repeat CCBT in 70% of cases and theremainder have TAU. The transition probabilitiesassociated with TAU are the same as cycle 1 (i.e.taken from the Proudfoot study). For those in atreatment arm, it is assumed for simplicity that thetransitions are the same for all the CCBTpackages as for BtB. Transition rates were notavailable for Cope and the numbers in the trial ofOvercoming Depression are too small to estimatetransition rates between all four severitycategories. This assumption is favourable to Copeand Overcoming Depression since patientsreceiving these two forms of CCBT had smallergains on the BDI than BtB.

Given the weaknesses in the assumptions aboutlongevity it has been important to express this inthe distributions used in the probabilistic sensitivityanalysis (PSA). However, to test the sensitivity ofthese assumptions, the model has been run for onecycle only, assuming no benefit after the 8-monthfollow-up of the Proudfoot study.

Quality of life dataA systematic review was undertaken of publishedhealth state values in patients with depression.This is reported in detail in Appendix 10. Themain finding was that published studies did notuse the NICE reference case for economicevaluation of a generic preference-based measurevalued using UK general population values.Furthermore, the published data did not link tothe quality of life measures used in the studies ofCCBT. A search for studies using genericpreference-based measures in depression andanxiety identified the PHASE RCT of supervisedself-help CBT in primary care,54 which used theEQ-5D and CORE-OM. This provided a usefulsource of data because the patients were recruitedfrom 17 primary healthcare teams and werebroadly representative of the NHS. However, itused the CORE-OM rather than the BDI, but it issimilar in many ways to the BDI, and CORE-OMhas been mapped onto the BDI by the developerof the CORE-OM (Barkham, University of Leeds:personal communication, 2004). The mapping

function was fitted to provide a BDI score on eachcase.

The Richards study54 provided data on 62 patientswith BDI total scores and EQ-5D data. An initialsimple regression model indicated that therelationship between the BDI score and the EQ-5D was not linear, so it was decided to estimatemean (SD) scores for three depression categoriesof mild to moderate, moderate to severe andsevere, of 0.78 (0.20), 0.58 (0.31) and 0.38 (0.32),respectively. As in the trial, there were no patientswith scores in the minimal category since bydefinition they would not be suitable for the trial.It was assumed that patients in this minimalcategory would have age- and gender-matchednormal scores for this group of 0.88 (0.22).133 Asdiscussed in Appendix 10, these scores arecomparable to those obtained in other studies onhealth state values on similar groups of patients.

Cost dataCCBT has an impact on costs in two ways. One isfrom the cost of the intervention itself. The othercomes from the fact that it alters the distributionof patients between depression severity categories,which in turn has implications for the use ofservices.

Cost of the interventionThe provision of CCBT results in costs from thefollowing: licence fees, computer hardware,screening of patients for suitability, clinicalsupport, capital overheads (for facilities forcomputer and clinician) and the training of staff.While there are a number of important differencesin the costs of the three products, the basicprinciples of costing are very similar (seeAppendix 11 for details).

Each product comes with a licence fee tariff, withall products offering a fixed fee for purchase atthe level of general practice. Cope also offerslicences at different organisational levels: PCT,strategic health authority, NHD PASA consortiumand country (England, Wales and Scotland). Thecost per GP and per patient is substantially less atthese higher levels of purchase. For this costingexercise, it has been decided to limit the costingsto general practice and PCT level, since it seemsunlikely that the NHS would purchase theseproducts above practice or PCT levels. To do sowould be a major break with current purchasingpatterns.

The licence fee is fixed, so the cost per patientdepends on the number of patients likely to use

Economic analysis

40

each copy. The assumptions used in thesubmissions were unrealistically high and morerealistic values have been used for actual practicelist size and the numbers of prevalent cases knownto the GP (Appendix 11). The number of treatedpatients in a one to five GP practice is expected tobe 25–50 and for a five to ten GP practice 40–80.The costings are based on midpoint estimates of37.5 and 60 patients, respectively, at practice level.For PCTs the number of patients likely to betreated is 825–1650 rather than 2000, with a mid-point estimate of 1237.5.

For BtB, Overcoming Depression and Cope,practices will need to provide a computer andspace for it. Cope, however, does not require amachine to be available in general practice sincepatients can access it over the Internet at otherlocations, such as at home or in a public library,and so this latter option has also been costed.

For BtB and Overcoming Depression, there will besupport provided by a professional to help thepatients to use the computer program. This hasbeen estimated in BtB to be equivalent to aboutan hour of time over the duration of treatment(which can be up to 3 months). For Cope themanufacturer recommends their products besupported by a brief helpline. The manufacturerassumes a total of 1-hour support per patient overthe 3 months of therapy. These have been costedusing NHS costs allowing for on-costs andoverheads. All products are assumed to have noadditional impact on use of GP time, althoughthere is an additional element for the time forstaff involved in training for the use of CCBT intheir practice. There is also additional time spentassessing the suitability of the patient for CCBT.

Other costsCCBT has an impact on the severity level ofdepression compared with TAU, which hasconsequences for the use of other services.Analysis of the economic data provided byMcCrone120 (personal communication) from theProudfoot study87 found that mean costs vary byseverity level, but that the treatment arm did notmake a significant independent contribution.Combined post-treatment mean costs by severityhave been used in the model and these are£122.50 (85.74) for minimal, £253.50 (275.16) formild, £274.64 (505.07) for moderate and £423.93(741.93) for severe depression.

DiscountingCosts and outcomes (QALYs) were discounted atthe recommended Treasury rate of 3.5% and a

sensitivity analysis was performed using the oldDepartment of Health rates of 1.5% for QALYsand 6% for costs.

AnalysisThe cost-effectiveness results are presented interms of incremental cost per QALY of eachproduct. The uncertainty around parameterinputs is presented in Appendix 12. To handlethis uncertainty in the most efficient way a PSAwas performed to investigate uncertainty aroundthe key parameters. The probabilistic sensitivityanalysis consists of 10,000 runs, where each of therandom parameters is drawn from its owndistribution to give a cost-effectiveness of eachtreatment. The probabilistic sensitivity analysis isintended to capture most of the uncertainty in themodel; however, one variable that is not capturedis the organisational level at which the NHSwould purchase CCBT. This will be explored inunivariate sensitivity analysis along with other keyparameters. Uncertainty around longevity willalso be explored by removing any benefit beyond8 months. Finally, a subgroup analysis wasundertaken using the BtB model to examinepossible variation in cost-effectiveness by severity.

ResultsBeating the Blues modelCosts were estimated for a single-copy licence anda 20-copy licence (Appendix 11). The single-copylicence is equivalent to a one to five GP practicepurchasing the product. The 20-copy licence isequivalent to a PCT purchasing a licence(although it is not clear in the submission whetherthis is available to PCTs). The estimated cost ofthese is £219.30 and £104.62, respectively, pertreated patient. These estimates come with largeranges, reflecting the uncertainties around theunit costs and, more importantly, the uncertaintiesaround the expected numbers of patients treatedat practice level.

The transition probabilities, quality of life andcosts used in the economic model on BtB areshown in Appendices 9–11. Means anddistributions are presented along with datasources.

BtB was found to be more effective and morecostly than TAU. The incremental cost per QALYof BtB over TAU is £1801 (Table 9). Figure 3 showsthe CEAC. The probability of accepting BtB overTAU at 30,000 is 86.8%.

The PSA is intended to capture most of theuncertainty in the model, but some variables were


41


explored in a one-way sensitivity analysis. Usingthe discount rates of 6% for costs and 1.5% forQALYs results in little change to the cost perQALY (i.e. £1709). The above analysis assumesthat the licence would be held at practice level,but it might be offered to PCTs at the lower ratefor 20 copies. If this were the case, then theincremental cost per QALY would fall to £415.Finally, running the model for one cycle (i.e.limiting it to the duration of the Proudfoot trial)increases the cost per QALY to £4961.


Subgroup analysisThe incremental cost per QALY was estimated forpatients presenting with mild to moderate,moderate to severe and severe depression atbaseline using data from the Proudfoot trial.There were some patients with minimaldepression, but these were excluded from thisanalysis. Severity level-specific transitionprobabilities shown in Appendix 12 were used;otherwise the parameter values are the same. Theresults in Table 10 show that the mild to moderategroup has the lowest mean incremental cost perQALY of £1802, but there is little differencebetween the groups.

Economic analysis

42

TABLE 9 Cost-effectiveness of BtB

Strategy Cost (£) Incremental cost (£) Effectiveness Incremental effectiveness ICER

TAU 437 1.02BtB 584 147 1.10 0.08 1801

TABLE 10 Cost-effectiveness by severity category


Mild to moderateTAU 366 1.13BtB 497 131 1.20 0.07 1802

Moderate to severeTAU 436 1.02BtB 593 157 1.11 0.08 1844

SevereTAU 546 0.86BtB 700 154 0.95 0.08 1851

Willingness to pay (£)

Prop

ortio

n co

st-e

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0 26,000 52,000 78,000

1.0

0.9

0.8

0.7

0.60.5

0.4

0.3

0.2

0.1

0

BtBTAU

FIGURE 3 CEAC for BtB

CopeParameter values: costsTwo costings were undertaken for practice-levellicences, one assuming that the practice will haveto provide computer access and the otherassuming that patients can access the Internetfrom home or some other location that is cost freeto the NHS (Appendix 11). Both options include acost for a telephone support line for 1 hour perpatient for a course of CCBT. The estimated costis £171.30 for no practice computer access and£195.86 with practice computer access. At the PCTlevel, the cost falls to £110.53. These estimatescome with large ranges, reflecting theuncertainties around the unit costs and, moreimportantly, the uncertainties around the expectednumbers of patients treated at practice level.

The company will also be marketing IVR Cope,but only at strategic health authority or nationallevel. It is unlikely that the NHS would be willingto buy this at these organisational levels and sothis option has not been costed. Furthermore, thelicence would cost 40% more than the computer-based version of Cope.

Transition probabilitiesData on the probability of being in one of the fourstates post-therapy were estimated from the Markstrial.89 An individual-level data set was not

available for this trial, so assumptions were madeabout the likely distribution around the mainvalues reported before and after treatment fromthe study. It was assumed that the distributionaround the mean BDI post-treatment values wouldbe a normal distribution. The BDI cut-off pointswere used to calculate the proportions in eachseverity category. The cost of the licence chosen inthis model is the one calculated on a GP practicelevel (Appendix 11).

The model assumes a comparable starting point toBtB. The mean TAU arm is the same as BtB, butwith a larger range of uncertainty reflecting thesmaller number in the Cope study. All the otherdata used in the model are the same as for BtB.

ResultsCope was found to be more effective and morecostly than TAU. The incremental cost per QALYof Cope over TAU is £7139 (Table 11). Figure 4shows the CEAC as a summary of the 10,000 runsfrom the model. At £30,000 per QALY theprobability of acceptance stabilises at 62.6%.

The above analysis assumes that the licence wouldbe at a practice level, but it might be offered toPCTs at the lower rate. If this were the case, thenthe incremental cost per QALY would be £3915.The discount rate has little impact at £6078 per


43


TABLE 11 Cost-effectiveness of Cope


TAU 437 1.02Cope 630 193 1.05 0.03 7139


Prop

ortio

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st-e

ffect

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0 26,000 52,000 78,000

1.0

0.9

0.8

0.7

0.6

0.5

0.4

0.3

0.2

0.1

0

Cope

TAU

FIGURE 4 CEAC for Cope

QALY. Limiting the model to one cycle increasesthe cost per QALY to £16,469.

Overcoming DepressionCostsCosts were estimated for a single licence with oneand two copies and a PCT licence of 20 copies(Appendix 11). The sponsor offers the product at£500 for a licence to a practice and £50 forsubsequent copies. PCTs can bulk buy on behalf ofpractices at a discount and for this costing it isassumed that they buy 20 copies, one for eachpractice, with a 20% discount (Taylor-Parker,Calypso: personal communication, 2004). Theestimated cost of these options is £72.64 and £66.64 per treated patient, respectively. Thisis the cheapest CCBT product for this condition.

These estimates come with large ranges reflectingthe uncertainties around the unit costs and moreimportantly, the uncertainties around the expectednumbers of patients treated at practice level.

Transition probabilitiesThe probability of being in one of the four statespost-therapy was estimated from individual-levelstudy data provided by Whitfield.93 However, it

was not possible to estimate transitions betweenpretreatment and post-treatment states becausethe numbers available were too small to populate atransition matrix. Instead, a pretreatment meanhealth state value was used in the model. The BDIscore of patients in the Whitfield study93 beforeentering in the clinical trial is slightly higher thanfor Cope and BtB, reflecting more severe cases ofdepression. All other data are the same as in BtBand Cope.

ResultsOvercoming Depression was found to be moreeffective and more costly than TAU. Theincremental cost per QALY of OvercomingDepression over TAU is £5391 (Table 12). Aprobabilistic sensitivity analysis was performed toinvestigate uncertainty around the key parameters,as before. The distributions used around eachvariable are shown in Appendix 10. The very lowsample size of the main study again increased therange of values. No other allowance was made forthe uncertainties from using the TAU fromanother study.

Figure 5 shows the CEAC. At £30,000 per QALY,the probability of accepting OvercomingDepression over TAU is 54.4%.

Economic analysis

44

TABLE 12 Cost-effectiveness of Overcoming Depression


TAU 437 1.01Overcoming Depression 501 64 1.03 0.01 5391


Prop

ortio

n co

st-e

ffect

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0 26,000 52,000 78,000

1.00.90.80.70.60.50.40.30.20.1

0

Overcoming Depression

TAU

FIGURE 5 CEAC for Overcoming Depression

One variable that is not in the PSA is theorganisational level at which the NHS wouldpurchase the product. The above analysis assumesthat it would be at a practice level, but it might beoffered to PCTs at the lower rate. If this were thecase, then the incremental cost per QALY wouldbe £4856. At the old discount rates of 6% for costsand 1.5% for QALYs, the cost per is £5343.Limiting the model to one cycle increases the costper QALY to £26,087.

DiscussionThe main limitations lie in the assumptions oncompliance rates, rates of relapse, clinicaleffectiveness and throughput.

It was assumed that the probability of non-compliance is 30%. It might be that this rateshould be even higher as CCBT is still a newintervention. However, this is not likely to have alarge impact on the final cost per QALY. It wasassumed that the relapse rate for CCBT is thesame as traditional CBT. This assumption is astrong one and needs to be validated withappropriate research in the field, although again,it may not dramatically alter the result.

There is a considerable amount of uncertaintyaround the cost of the licence per patient due touncertainty in the throughput of people receivingCCBT. This is one of the main drivers of cost andis a major unknown. The licence costs also dependon the organisational level of purchasing, withPCT and higher organisational levels attractinglower costs per practice. For the PCT licence toresult in a major cost reduction per patient eachpractice would have to use the package asefficiently as those practices who buy it forthemselves under the practice licence option.

Finally, there are questions surrounding theclinical data, particularly for Cope andOvercoming Depression where there have notbeen any controlled trials.


ConclusionIt is difficult to compare across product giventhere have been no head-to-head comparisons andthe main clinical studies were undertaken ondifferent populations. However, BtB achieves thelowest cost per QALY across the three productsMore importantly, the strength of BtB lies in thefact that it has been evaluated in the context of anRCT with a control group. For this reason there is

less uncertainty around the results and this isreflected in a higher level of acceptance in thePSA compared with the other products (86.8%versus 62.2% and 54.4%). The subgroup analysissuggests that the cost-effectiveness of theseproducts is not altered by the severity ofdepression (for mild to moderate, moderate tosevere and severe).


Panic phobia (FearFighter)The question addressed by the model is whatwould be the likely impact of CCBT on the costsand effectiveness of treating patients with panicphobia in a primary care setting compared withclinician-led therapy and TAU.

StructureThis model draws heavily on the RCT by Marks,which compares FF to TCBT and relaxation.88

TCBT is equivalent to standard clinician-led CBTof six hourly sessions. Relaxation involved around1 hour of contact time with a trained behaviouraltherapist. Relaxation acts as a TAU arm and hasbeen chosen because it was the control arm in theMarks trial.88

The model is a four-cycle discrete-state Markovmodel lasting for 12 months, and each cyclelength is 3 months. It is a very simple modelwhere patients are assumed to be either well orsuffering from panic phobia. A schematic of themodel is shown in Figure 6. At the first cyclepatients start in the panic phobia state and eitherrespond to treatment and move to the well state orstay in the panic phobia state. In the next cyclepatients are assumed either to remit (stay in thewell state) or to relapse back into the panic phobiastate. In cycles 3 and 4, patients move betweenstates depending on where they are; thus, patientsin the well state can remit or relapse, and patientsin the panic phobia state can respond to therapyand move to well or stay out.

Parameter inputsTransition probabilitiesRates of response are taken from the Marksstudy88 using the global phobia item from the FQ.A cut-off point of 4 was chosen, where it isassumed that those who score lower than 4 post-treatment are responders, while those who have ascore equal to or higher than 4 are not responding(i.e. they stay in the same panic phobia state). Thiscut-off is justified on the grounds that it was aninclusion criterion for entering the Marks trial and


45


one of its primary outcomes.88 Moreover, thedevelopers of the scale suggest that a score of 4 ormore indicates a clinical disability.134 The responserate used in the model was elicited by placing anormal distribution with mean and standarddeviation equal to the post-treatment scores in thetrial.

RelapseThere is a very limited literature on relapse ratesin this patient group; what there is refers more tothe natural history of disease than to relapse ratesafter CBT, and there is nothing on CCBT. Thiswas taken from a study by Liebowitz that estimatedthe annual relapse rate in CCBT versusphenelzine in social phobia.135 Relapse wasdescribed as the manifestation of panic attackafter accomplishing full recovery. The annual rateestimated in this study was 17% and this has beenconverted to a 3-month rate of 0.045. It is alsoassumed in the model that the relapse rate is thesame for CCBT and clinician-led therapy.

Cost dataCCBTThis product is made by the same manufacturersas Cope and is to be marketed at the same price asNetCope. The costs associated with the product interms of licence fees, computer hardware,screening of patients for suitability, clinicalsupport, capital overheads (for facilities forcomputer and clinician) and the training of staffare the same as for NetCope. The manufacturersargue there will be the same level of demand forFF as for Cope, and this has been assumed in thecosting. However, the ONS survey suggests thatthe prevalence of panic phobia is somewhat lowerthan that of depression and so the average costper patient may be underestimated.

In their submission the sponsors suggest atelephone support line and this has been costed inthe economic model as for NetCope. However, theMarks trial88 used a face-to-face meeting with aclinician averaging 76 minutes per patient. Thissecond method of providing support would cost£29 compared with the cost of £35 from telephonehelpline support and so makes little difference tothe costs.

TCBTThere is considerable uncertainty around the likelycost of clinician-led therapy.52 This stems from thevariation in treatment length and the qualificationof the therapist. Published costs vary from as lowas £191 up to the figure in the NICE DepressionGuidelines of £867. The figure used in this reportwas based on the Marks trial, but in practice theactual cost of TCBT may be different.

The cost of TCBT is based on a shortened courseof CBT provided in the Marks trial88 of six hour-long individual treatment sessions. The actualaverage amount of treatment received was 2.83contact-hours per patient. It is assumed that theunused sessions are wasted and treatment is costedon the basis of 6 hours. The Marks trial used acombination of nurse and psychiatrists. In primarycare it is unlikely to be provided by a clinician andso it has been costed for a clinical psychologist at£66 per hour,136 giving a total cost of £396. Thecost would be substantially less if a practice nurseprovided the treatment.

RelaxationThis was a computer-guided programme ofrelaxation supported by brief face-to face helpfrom a clinician of up to 5 minutes coaching andreview before the session and up to 15 minutes

Economic analysis

46

Panic phobia Well

Response

Relapse

FIGURE 6 Markov model for panic phobia

spent discussing progress and giving extratreatment advice at the end. In the trial patientsreceived a total of 76 minutes of such clinicalsupport. This is costed as 1 hour at £23 for apractice nurse.136

For the depression model, the other costsassociated with the different levels of severity wereestimated from the Proudfoot study.87 There is noevidence on the impact of CBT, TCBT orrelaxation on other health-service usage. In themodel the only other cost is for patients whorelapse or remain in an ill state, where it has beenassumed that there will be an additional GP visitbetween cycles.

Quality of life dataThe review of utilities data on phobia yielded justone possible source of evidence, namely theEuropean Study of the Epidemiology of MentalDisorders (ESEMeD) survey.137 The details of thisare explained in Appendix 10, but essentially itwas a large, community-based mental healthsurvey across Europe, in which members of thegeneral population underwent a range ofpsychiatric assessments and completed a series ofquality of life instruments, including the EQ-5Dand the Short Form 36 (SF-36).

Table 13 shows the quality of life attached to threephobic states and no disorder for the EQ-5D.138

These data are not ideal for the economic model.The patients are not the same as those recruitedinto the Marks trial. The ESEMeD samplecomprises people who were found to have thesemental disorders over the past 12 months. It is amixed group of patients, some of whom will beexperiencing some degree of remission as well asthose in the worst phases of the condition. It isunclear how these relate to the patients in thetrial. Furthermore, it is not clear how much thesespecific disorders contributed to these quality oflife scores. If these patients have been cured oftheir condition it is not clear that they would have

been restored to the value for those with nodisorder. Nonetheless, this sample is the bestavailable evidence.

DiscountingThere is no discounting because the model onlyruns for 12 months.

AnalysisThe cost-effectiveness results are presented interms of incremental cost per QALY of eachproduct. The uncertainty around parameter inputsis presented in Appendix 12. To handle thisuncertainty in the most efficient way a PSA wasperformed to investigate uncertainty around thekey parameters. The probabilistic sensitivityanalysis consists of 10,000 runs, where each of therandom parameters is drawn from its owndistribution to give the cost-effectiveness of eachtreatment. The PSA is intended to capture most ofthe uncertainty in the model; however, onevariable that is not captured is the organisationallevel at which the NHS would purchase theproduct. This will be explored in univariatesensitivity analysis.

Results Parameter values The costs of FF are the same as for NetCope andare shown in Appendix 11. Two costings weredone for practice-level licences, one assuming thatthe Internet can be accessed by patients eitherfrom home or at some other location that is costfree to the NHS, and the other assuming Internetaccess via the local practice, and one PCT-levelcosting. The estimated cost of these is £171.30 forthe first practice-level option, increasing to£195.86 if the practice has to provide computeraccess. At the PCT level, the cost falls to £110.53.These estimates come with large ranges, reflectingthe uncertainties around the unit costs and, moreimportantly, the uncertainties around the expectednumbers of patients treated at practice level. Ifthis disorder resulted in a lower throughput thandepression, then the average costs would behigher than for NetCope.

The data used to populate the model, quality oflife and costs used in the economic model areshown in Appendix 12.

ResultsRelaxation is the least costly strategy, but also the least effective (Table 14). The results show that there is no clear dominance betweeninterventions. In terms of their incremental cost-effectiveness, FF achieves a cost per QALY of


47


TABLE 13 Health state values for patients with panic phobia:ESEMeD survey137

Condition over past EQ-5D12 months

n Mean 95% CI

Social phobia 218 0.79 (0.75 to 0.84)Agoraphobia 86 0.79 (0.73 to 0.84)Specific phobia 698 0.82 (0.80 to 0.85)

No disorder 2133 0.91 (0.97 to 0.98)

£2380 over the largely ineffective relaxation.Using the self-reported global phobia item,clinician-led therapy is more effective than CCBT,although this was not statistically significant and isnot a consistent finding across the outcomemeasures. However, using this figure results in anincremental cost per QALY of TCBT over FF of£17,608.

Figure 7 shows the CEAC calculated on 10,000runs of the model. At £30,000 per QALY the rateof acceptance for FF is 39% and for TCBT 61%.At this point the curves are still diverging.

The main analysis was performed using a highcost of FF (cost at GP practice level). A sensitivityanalysis using a lower cost estimate (cost at PCTlevel) results in the incremental cost-effectivenessof FF over relaxation being reduced to £901 andthe incremental cost-effectiveness of TCBT overCCBT being increased to £25,432.

DiscussionResults from this model have to be interpretedwith care. The economic model provided a means of extrapolating from the Marks trial88

to a full year. To do this, the results on recoveryfrom the trial were combined with the assumptionthat relapse is the same for CCBT and TCBT.

To construct the Markov model, data on symptomsfrom the Marks trial88 were converted into asimple dichotomous cut-off to populate theMarkov model and to link to health state utilityvalues from a European-wide survey of theseconditions. There is considerable uncertaintyabout these connections. The time framework forthe model is only 12 months. The benefits maypersist beyond 12 months, but it was feltuntenable given the short follow-up in the trial.

ConclusionCCBT seems to be cost-effective compared withdoing nothing. However, it is more difficult tojudge its effectiveness compared with TCBT. Ashortened variant of CBT was found in the Marksstudy88 to be marginally more effective than CCBT,although this was not a statistically significantfinding and was not consistent across outcomemeasures. The extent to which this possible extraeffectiveness is worth the extra cost depends onthe relative costs of CCBT and CBT, and these tooare uncertain. Currently, the evidence seems tooweak to allow comment on the relative cost-effectiveness of the CCBT product compared withTCBT.

OCD (BT Steps)The question addressed is: what would be the likelyimpact of BT Steps on the costs and effectiveness

Economic analysis

48

TABLE 14 Cost-effectiveness of FF


Relaxation 78 0.736FF 217 138 0.794 0.058 2,380TCBT 410 194 0.805 0.011 17,608


Prop

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0 11,000 22,000 33,000 44,000

1.00.90.80.70.60.50.40.30.20.1

0

FFClinicianRelaxation

FIGURE 7 CEAC for panic phobia

of treating these patients compared with thealternatives of clinician-based therapy and TAU?

StructureThis decision-tree model draws heavily on theGreist trial,115 which has three arms: BT Steps,TCBT and relaxation. The variant of TCBTconsists of clinician-guided therapy of 11 weekly 1-hour sessions to negotiate self-exposurehomework. The relaxation therapy patients areasked to perform relaxation exercises on a dailybasis for 10 weeks. The latter provides a TAUgroup for the model and is an arm in the Greisttrial.115 The decision-tree diagram is shown inFigure 8.

As with the depression model, it runs for 18months with two main cycles. Patients start with adiagnosis of OCD (total score on the YBOCS of atleast 16) and receive treatment with BT Steps,TCBT or relaxation. Patients receiving BT Stepseither comply with treatment or do not. Thosewho comply may respond or not respond at theend of 2 months. Those who respond are assumedto enter a well state for 6 months. Those who failto respond or fail to comply remain in the OCDstate for 6 months and are then offered relaxationand experience the outcome associated with thattherapy (see below). Those who initially respondto BT Steps may relapse back to having OCD after6 months and these too will be offered relaxationin the next cycle. Those who have clinician-ledtherapy follow the same structure. Relaxationpatients also follow a simplified version of thisstructure.

Parameter valuesComplianceThe rate of non-compliance is assumed to be30%. This is similar to the dropout rates in theclinical trials and submissions on CCBT, althoughthe dropout rate is a loss for various reasons, oneof which would be compliance. People who dropout from CCBT receive TAU straight away. Thiscompliance rate is applied to all arms of thestudy.

Response rate dataYBOCS data from the Greist trial115 were used todefine responders and non-responders. Patientsrecruited into this trial had to have a YBOCSscore of 16 or more (Table 15). The resultant meanpretreatment score was around 25, and this wasused to define non-responders after treatment. A responder is defined as someone experiencing a35% improvement in YBOCS with respect to hisor her original score.139 This is a little morestringent than the 25% improvement commonlyused in the literature, but results in a mean scoreof 16 post-treatment that represents the cut-offvalue for the trial. A normal distribution wascentred on the YBOCS mean score and standarddeviation post-treatment. The proportions ofthose who score less than the cut-off point definethe proportion of improved patients, as shown inTable 16.

Quality of lifeThe review of OCD found little evidence on thehealth state utility values of people with OCD(Appendix 10). The only study to have any data


49


Response

RelaxationNo response

Comply

RelaxationNot comply

BT Steps

Response

RelaxationNo response

Comply

RelaxationNot comply

Clinician

Response

Do nothingNo responseRelaxation

FIGURE 8 Decision tree for OCD

on this was the ESEMeD European community-based psychiatric survey, which included adiagnosis of OCD in the past 12 months. Themean EQ-5D health state utility value of peoplediagnosed with OCD was 0.85, compared with0.91 for those without disorder. However, it wasfelt that a better approach would be to use theYBOCS, since this would enable a more directlinkage to the Greist trial.115

The YBOCS is a self-rated questionnaire that askspeople about their obsessive and compulsivesymptoms. It generates scores for these twodomains and a total score based on a simplesummation of these scores. The ESEMeDundertook a mapping exercise for use between theYBOCS and the EQ-5D and found that a 1-pointreduction in the obsessive scale was equivalent to a0.03 reduction in the EQ-5D preference scale(p=0.0006). This algorithm was applied to theGreist data to convert those who responded intoEQ-5D scores.

YBOCS values for non-responders are assumed tobe 25 (i.e. the mean pretreatment score) andresponders to be equivalent to a post-treatmentscore of 16. These scores were converted into EQ-5D scores by applying the mapping functionfrom the obsessive scale to the 0.04 decrement per point change in the score. The change in theobsessive score was estimated to be half of theoverall change in YBOC score. The EQ-5D valuesestimated in this way are 0.92 (0.07) forresponders and 0.80 (0.15) for non-responders.

Cost dataCCBTThe same manufacturer as Cope makes thisproduct and it is to be marketed at the same priceas NetCope. The costs associated with the productin terms of licence fees, computer hardware,screening of patients for suitability, clinicalsupport, capital overheads (for facilities forcomputer and clinician) and the training of staffare the same as for NetCope. The only differenceis the fact that the number of patients with OCD issignificantly lower. The sponsor used a prevalencefigure of 2% rather than 10%. This results in the

following reduction in throughputs: a one to fiveGP practice goes from 20 to 7.5 (range 5–10), asix to ten GP practice from 40 to 12 (8–16) and aPCT from 400 to 247.5 (165–330). All other costsare assumed to be as for Cope. The lowerthroughput of BT Steps compared with Coperesults in a lower level of helpline supportrequired per copy; otherwise, the total costs arethe same as for Cope. This results in costs pertreated patient that are substantially higher thanthe other CCBT products.

TCBT and relaxationThe exact amount of clinician-led therapy likely tobe provided on the NHS is unclear, so this analysisused the figure given in the Greist trial of 11hourly sessions. At £66 pounds per hour for aclinical psychologist136 this equates to a cost of£726. The course of relaxation is assumed to bethe same as for FF of approximately 1 hour at acost of £23.

For the depression model, the other costsassociated with the different levels of severity wereestimated from the Proudfoot study. There is noevidence on the impact of CBT, TCBT orrelaxation on other health-service usage. In themodel, it is assumed that the patient will visit theirGP in search of alternative treatment when theyfail to comply, and this is costed at £26 per visit.136

DiscountingCosts and outcomes (QALYs) were discounted atthe recommended Treasury rate of 3.5% and asensitivity analysis was performed using the oldDepartment of Health rates of 1.5% for QALYsand 6% for costs.

ResultsParameter valuesThe cost structure for BT Steps is the same as forFF and NetCope, with the only difference beingthe substantially lower levels of throughput. Twocostings were done for practice-level licences, oneassuming that the Internet could be accesseddirectly by patients and the other from generalpractice, and one PCT-level costing. The estimatedcost per patient is £714.49 for the first practice-

Economic analysis

50

TABLE 15 Responders using the YBOCS

Baseline mean End-point 35% reduction Cut-off point Responders (SD) for responder below cut-off (%)

BT Steps 24.6 (4.3) 19.0 (7.2) 8.61 15.99 33Clinician 25.2 (4.6) 17.6 (6.2) 8.82 16.38 42Relaxation 25.8 (5.1) 24.1 (6.7) 9.03 16.77 13

level option and £837.23 if the practice has toprovide computer access. At PCT level, the costper patient falls dramatically to £248.83. Theseestimates come with large ranges, reflecting theuncertainties around the unit costs and, moreimportantly, the uncertainties around the expectednumbers of patients treated at practice level.

TCBT has a cost per QALY of £18,342 overrelaxation (Table 16). The incremental costs perQALY show that clinician-led TCBT dominates BTSteps. At £30,000 per QALY, TCBT is cost-effective on 58% of occasions (Figure 9).

Applying discount rates of 6% to costs and 1.5% toQALYs has little impact on the cost per QALY. A sensitivity analysis was undertaken using the

lower estimate of BT Steps from purchasing atPCT level. The results are shown in Table 17. Atthe lower cost per patient, there is no dominatedstrategy. The cost per QALY of BT Steps overrelaxation is £15,581 (Table 17). Assuming a cost of£66 per session for TCBT, then it costs more for aslightly larger effect, with a mean incremental costper QALY of £22,484.

DiscussionThere are considerable limitations to the modelused to examine the cost-effectiveness of BT Steps.The health state utility values were based on a veryindirect method and there is considerableuncertainty in the values used. The cost per patient of BT Steps is considerably higher thanthat of the other CCBT products. The relative cost


51


TABLE 16 Cost-effectiveness of BT Steps and TCBT


Relaxation 45 1.202TCBT 518 474 1.228 0.026 18342BT Steps 878 360 1.218 –0.010 Dominated


Prop

ortio

n co

st-e

ffect

ive

0 26,000 52,000 78,000

1.0

0.9

0.8

0.7

0.6

0.5

0.4

0.3

0.2

0.1

0

BT Steps

Clinician

Relaxation

FIGURE 9 CEAC for BT Steps

TABLE 17 Sensitivity analysis on OCD (low cost of BT Steps)


Relaxation 45 1.202BT Steps 286 241 1.218 0.015 15,581TCBT (clinician led) 518 232 1.228 0.010 22,484

of BT Steps depends crucially on the licence, witha practice licence leading to BT Steps costingmore than TCBT. A PCT licence brings the cost tobelow that of BT Steps, but TCBT could beoffered at lower cost if practice nurses providedmost of the therapy. The sponsor may decide tochange its tariff for BT Steps in the light of thisanalysis.

ConclusionThere is considerable uncertainty around the cost-effectiveness of BT Steps. While it achieves a lowercost per QALY against relaxation, compared withTCBT there is too much uncertainty to draw firmconclusions. TCBT was found to be more effectiveand seems to cost less than BT Steps for a practicelicence, but it may cost more with a PCT licence.

Cost impactThe cost impact was estimated using the modelsdeveloped for assessing cost-effectiveness, ratherthan directly from the licence fee schedulesprovided by the sponsors. This is because theimpact of CCBT on costs is far wider than thelicence fee. The provision of CCBT also results incost consequences from computer hardware,screening of patients for suitability, clinicalsupport, capital overheads (for facilities forcomputer and clinician) and the training of staff.CCBT also has an impact on costs via changes tothe severity level of each condition. Theconsequences of changing severity group havebeen estimated for depression, but it was notpossible to do this for the other conditions. Fordepression the incremental cost over TAU allowsfor possible reductions in the use of existingservices. For panic phobia and OCD, the costingassumes that the CCBT is additional to existingservices. Costing methods have been describedbriefly earlier in this chapter and are detailed inAppendix 11.

BtB and Overcoming Depression have a licencefee tariff for single copies for purchase at the levelof general practice. Cope, FF and BT Steps alsooffer licences at different organisational levels:PCT, strategic health authority, NHD PASAconsortium and country (England, Wales andScotland). For the cost-effectiveness analysis, it wasdecided to limit the costings to the level of generalpractice and PCT, since it seems unlikely that theNHS would purchase these products above thislevel. For this costing, the authors propose to dothe same.

Tables 18 and 19 present the estimated cost impactof the different CCBT products in England andWales for practice and PCT licences. These costestimates are based on the assumption that allpractices and PCTs will purchase a licence. Thecosts differ between products owing to differencesin cost of the licence (Overcoming Depression hasthe lowest cost licence), effectiveness (withconsequence impact on severity) and throughput(BT Steps, for example, treats fewer patients andso incurs fewer non-licence fee costs).

The costs presented in Tables 19 and 20 differconsiderably from the fee for a national licence forCope, FF and BT Steps provided in the sponsorssubmissions of £4,900,000 for England and£280,000 for Wales. The reason for thediscrepancy is not just the differences in thelicence fees, but also the fact that the modelsincluded other cost consequences of theinterventions. However, presenting the nationalcost impact raises a question about the possibilityof national licence agreements. The cost-effectiveness assessment did not look at thisoption, but it may be possible to negotiatediscounts for the NHS and this could substantiallyalter the total costs, although the impact on cost-effectiveness will depend on throughput levels.The sponsor submissions assume a constantthroughput across licences, but it is likely thatmany practices will not use the service asefficiently as those that purchase a practicelicence.

Economic analysis

52

TABLE 18 Cost impact in England

CCBT product Practice PCT licence (£) licence (£)

BtB 32,181,975 5,151,000Cope 42,252,525 16,059,000Overcoming Depression 14,011,200 8,635,500FF 45,317,475 11,817,000BT Steps 23,643,900 18,073,193

TABLE 19 Cost impact in Wales

CCBT product Practice PCT licence (£) Licence (£)

BtB 1,866,900 238,000Cope 2,451,100 742,000Overcoming Depression 812,800 399,000FF 2,628,900 546,000BT Steps 1,371,600 835,065


53


The NSF for Mental Health1 states that patientswho contact their primary healthcare team

with a common mental health problem shouldhave their mental health needs identified andassessed and be offered effective treatment. CBThas been identified by the NSF as being effectivein the treatment of depression. Currently, theNHS is unable to deliver CBT to all patients whomay benefit from it. Long waiting lists, too fewtherapists, expense and patients’ reluctance toenter therapy are some of the barriers preventingmany patients with depression, anxiety, phobiasand OCD from accessing services providing CBT.

As in the previous review, the evidence for CCBTis limited, although potentially promising for thetreatment of depression, anxiety, phobias andpanic. The implementation of a CCBT packagewithin the NHS requires careful consideration of anumber of issues. Computers need to be madeavailable either in a public place or in a patient’shome. Internet access of a suitable capacity wouldbe required for those packages delivered via theInternet. A designated person, such as a GP, nurseor therapist, would need to be responsible forimplementing CCBT and their training needswould need to be met. Money would also berequired for the licence fee. The appropriatemethod and length of screening to determinesuitability of patients for CCBT also need to betaken into consideration.

Computer use would not be acceptable to allpatients and alternatives would need to be offered.Options include bibliotherapy, group CBT andshortened courses of CBT. Other treatmentoptions need to be made available for those whodo not want to use CCBT or who try it and find itunacceptable. This is particularly important forelderly people, a group frequently presenting withsymptoms of depression, but for whom computerusage may be unacceptable.

Although the use of CCBT could potentially allowCBT to be made available to more patients,patients would need careful monitoring. This isparticularly true for patients with depressionwhere there is a suicide risk. CCBT packagescould potentially fit within a stepped careapproach to the treatment of these mentaldisorders. Formal assessment of patients isrequired to determine whether or not patients aresuitable and they need careful monitoringthroughout treatment.

Those CCBT packages available only over theInternet are potentially useful within the NHS andcan provide a complementary treatmentcomponent to usual care with a GP, who would beable to monitor progress at regular intervals andoffer alternatives when patients do not improvewith this approach.

Chapter 5

Factors relevant to the NHS


55


Main resultsClinical effectivenessTwenty studies (two of which were AIC) wereidentified in the clinical effectiveness review. Tenof these studies were of the included softwarepackages and ten were of other studies. Theresults from the RCT for BtB suggest that BtB ismore effective than TAU. The data provided forCope include no RCT evidence. In the two non-comparative trials provided, patients improvedfrom baseline. Likewise, the data provided forOvercoming Depression included no RCTevidence, although patients improved frombaseline. FF appears to be as effective as TCBT.BT Steps was not as effective as TCBT, althoughpatients improved from baseline.


With regard to the other ten studies, all apart fromone (a pseudorandomised trial) were RCTs. Sixinvolved studies of CCBT delivered via theInternet. Three studies of a program for panicfound CCBT and TCBT to be effective, but TCBTmore so, and more effective than WLC, but foundthat relaxation was more effective than CCBT. Twoother Internet-based programs for depression(ODIN and MoodGym) showed MoodGym to beeffective. ODIN was found to be ineffective in onestudy. Balance, another software program fordepression, was found to be effective on somemeasures compared with WLC. Finally, three studiesof CAVE, used to treat spider phobia, found CAVEto be effective, as well as TCBT and relaxation.


Cost-effectivenessReviewThe review of published studies identified oneeconomic evaluation of CCBT and was included inthe submission from Ultrasis for BtB. It was a cost-effectiveness analysis undertaken alongside arandomised clinical trial of BtB compared withTAU. It was well conducted and had good internalvalidity. The main weaknesses were: (1) the

assumed cost of intervention was based onunrealistically high expectations regarding thelikely numbers using the package at GP practicelevel; (2) the derivation of QALYs was based onsymptom-free days and so did not take into accountall potential benefit, and used non-reference casehealth state values; and (3) the trial was limited to 8 months and the benefits of BtB may extendbeyond this period. The assessment of BtB and theother packages for depression was based on aneconomic model that addressed these problems.

Sponsors of the other packages submittedinformation only on the costs of their products(and this was used in the economic model).

DepressionThe three products share the same basic modelstructure of a decision-tree model comparing twoarms, CCBT and TAU, over an 18-month period.TAU is difficult to specify, so this model used thetreatment received in the Proudfoot trial87 asrepresenting TAU in the NHS. TAU patients inthis trial continued to visit their GP, receivemedication and be referred to a specialist,although they were not receiving psychotherapy atthe time of entering the trial. TAU is assumed tobe the same across all three products. For practice-based licences, the overall intervention costs were£219.30 for BtB, £195.86 for Cope with practice-provided Internet access and £170.30 without, and£72.64 for Overcoming Depression. For PCT-based licences the costs fell to £104.62, £110.53and £66.64, respectively.

The BtB model was able directly to use the resultsof the RCT and simply extend the benefits byanother 10 months by making assumptions aboutrelapse rates taken from the literature on CBT.The primary end-point of the trial, BDI, wasmapped onto the EQ-5D to derive cost per QALY.The costs of the intervention were estimated usingmore realistic assumptions about likely throughputthan the submission. A key assumption was thatthe TAU arm of the BtB trial was appropriate forthese products.

The results in terms of incremental cost per QALYcompared with TAU and the likelihood of being

Chapter 6

Discussion

cost-effective at £30,000 per QALY were £1801and 86.8% for BtB, £7139 and £62.6% for Cope,and £5391 and 54.4% for Overcoming Depression.It is difficult to compare across product given thatthere have been no head-to-head comparisons andthe main clinical studies were undertaken ondifferent populations. However, the strength ofBtB lies in the fact that it has been evaluated inthe context of an RCT with a control group. Forthis reason there is less uncertainty around thecost-effectiveness of BtB. The subgroup analysisfound no difference across the severity groupings.


Phobia/panicFF was compared with TCBT and relaxation.TCBT is equivalent to standard therapist-led CBTand was designed to consist of six hourly sessions.Relaxation involved around 1 hour of contact timewith a trained behavioural therapist. Relaxationacts as a TAU aim and was chosen because it wasthe control arm in the main trial of this product.88

The economic model is a four-cycle discrete-stateMarkov model lasting for 12 months, and eachcycle length is 3 months. Patients are assumed tobe either well or suffering from panic phobia. Inthe first cycle patients start in the panic phobiastate and either respond to treatment to move tothe well state or stay in panic phobia state. In thenext cycle patients are assumed either to remit(stay in the well state) or to relapse back into thepanic phobia state. In cycles 3 and 4, patientsmove between states depending on where they are;thus, patients in the well state can remit orrelapse, and patients in the panic phobia state canrespond to therapy and move to well or stay thesame. A global phobia item in the trial was used toestimate transition probabilities and this waslinked to EQ-5D health state values from aseparate survey.

The overall intervention cost of FF was £195.86with practice Internet access and £171.30 without,and £110.53 for a PCT licence. The incrementalcost per QALY of FF over relaxation was £2380.Its position compared with TCBT is less clear.Although the Marks trial88 found TCBT to bemore effective than FF, this difference was neithersignificant nor consistent across outcomemeasures. Assuming that this is a significantdifference, the incremental cost per QALY ofTCBT over FF was £17,608, but the probability ofbeing cost-effective at £30,000 per QALY is just61%.

OCDCost-effectiveness was assessed using a decision-tree model with three arms: BT Steps, clinician-guided therapy and relaxation. TCBT consisted of11 weekly 1-hour sessions to negotiate self-exposure homework. Relaxation therapy patientswere asked to perform relaxation exercises on adaily basis for 10 weeks. This provides a TAUgroup for the model. These were the three arms inthe Greist trial115 and these were included in theeconomic model. The model uses a simpledichotomy: with OCD or well. The rate ofresponse to therapy and the quality of lifeassociated with these states were estimated from acondition-specific measure called the YBOCS.

The intervention cost of BT Steps per patient wasestimated to be £837.23 for a practice-basedlicence and practice access to the Internet and£719.49 with no access to the Internet in generalpractice. A PCT licence is much cheaper, at£248.83, assuming that it can achieve the samelevels of throughput per practice. Using thepractice-level licence cost means that BT Steps isdominated by TCBT, which had significantly betteroutcomes in the Greist trial115 and is cheaper.However, the cheaper PCT licence results in BTSteps costing less than the more effective TCBT.At the lower cost the incremental cost-effectivenessof BT Steps over relaxation is £15,581 and that ofTCBT over BT Steps is £22,484.

Assumptions, limitations anduncertaintiesClinical effectivenessLittle information was identified on the optimalsetting, and type of patient with regard to age,gender, ethnicity and socio-economic background.In most studies, recruitment was through self-referral. This does not reflect usual practice in GPsettings. There were large dropout rates in moststudies; it is unclear whether this is becausepatients got better and felt that they did not needtreatment or because they felt that they were notimproving.

Little information was provided in the studiesregarding patient preference. Patients may stillprefer TCBT or bibliotherapy and these issuesneed to be considered before there is a largecommitment made to the provision of CCBTthroughout the NHS. NICE issued guidance onthe use of CCBT for anxiety and depression inOctober 2002.80 The following recommendationsfor research were identified.

Discussion

56

● Clinical efficacy but not clinical effectiveness forBtB and FF has been established. Furtherinvestigation into the clinical efficacy of otherCCBT packages needs to be conducted. An RCTwas identified comparing BT Steps with TCBT.Apart from these two studies no new RCTevidence of the included packages was identifiedcomparing CCBT with TCBT or TAU.

● Optimum site of delivery needs to beestablished; that is, primary or secondary care,dedicated centres or via the Internet. No RCTevidence of the included packages wasidentified comparing CCBT in differentsettings.

● Criteria should be developed that allowidentification of the optimum CBT package(including CCBT) for individual patients. Nostudies were identified comparing CCBTpackages.

● Research is needed to identify individuals mostsuited to CCBT in preference to other methodsof delivery of CBT. No research was identifiedregarding preference, apart from some studiesindicating that patients showed some preferencefor TCBT.

● Processes for appropriate screening and referralfor CCBT need to be established andimplemented. No independent studies wereidentified investigating appropriate screeningand referral procedures.

● The role and place of CCBT within steppedcare need to be established and the use ofCCBT in conjunction with TCBT should beevaluated more fully. No studies of CCBTwithin a stepped care framework wereidentified.

● The level of facilitator involvement needed toproduce optimal outcomes for CCBT should beevaluated. No studies were identified thatinvestigated the level of facilitator involvement.

● Research is needed to compare the cost-effectiveness of CBT via a computerisedinterface with TCBT and usual GP care andwith a combination of these approaches.Evidence on this point is presented in Chapter4 of this report.

Research is still needed in these areas. As in thelast review, assumptions have been made inevaluating these studies that the investigators havebeen objective in assessing the programmes thatthey are using. However, investigator allegiancecan introduce strong bias in studies ofpsychological treatments.140 Many of the resultspresented in this report are from unpublishedtrials and have therefore not been peer reviewed.Undertaking research in a primary care setting is

associated with a number of difficulties, as shownin a recent study attempting to randomise patientsto BtB, TCBT or TAU.141

Cost-effectivenessDepressionThe main limitations of the cost-effectivenessestimates lie in the assumptions of the model. Thekey assumptions are around compliance, rate ofrelapse, clinical effectiveness and throughput.

It was assumed that the probability of non-compliance is 30%. CCBT is still a newintervention and there is little evidence on thelikely levels of compliance. It was assumed that therelapse rate for CCBT is the same as fortraditional CBT. This assumption is a strong oneand needs to be validated with appropriateresearch in the field.

There is a large amount of uncertainty in the costof the licence per patient owing to uncertainty inthe throughput of people receiving CCBT. Themodel used more realistic throughput levels, butthere is little evidence on the likely take-up inpractice. The licence costs also depend on theorganisational level of purchasing, with PCT andhigher organisational levels attracting lower costsper practice. However, the lower costs per patientassume that the PCT (or strategic health authorityor the NHS) is able to make sure that eachpractice uses the packages as efficiently as apractice purchasing its own copy; but in practice,for example, some practices may be less efficientat selecting cases.

It has been suggested that CCBT might be used ina stepped care programme, where patients areoffered interventions of increasing intensity andcosts depending on the severity of their conditionand recovery. The present models did not look atthis option because there is no evidence on thelikely effectiveness of such a programme. Astepped intervention is not simply the sum of itsconstituents, because the effectiveness of eachintervention will depend on what went before.This is an important area for research.

Phobia/panicThe economic model provided a means ofextrapolating from the Marks trial88 to a full year.The rate of relapse following CCBT was assumed tobe the same as for TCBT. To construct the Markovmodel, data on symptoms from the Marks trial wereconverted into a simple dichotomous cut-off topopulate the Markov model and to link to healthstate utility values from a European-wide survey of


57


these conditions. There is considerable uncertaintyabout these connections, but the model makes thebest use of available evidence. The time frameworkfor the model is only 12 months. The benefits maypersist beyond 12 months, but this was feltuntenable given the short follow-up in the trial.

While FF seems to be cost-effective compared withrelaxation, its position compared with TCBT isless clear owing to the uncertainties. The Markstrial88 has small numbers and this makes itdifficult to interpret the difference found betweenCCBT and TCBT. Furthermore, there isconsiderable uncertainty surrounding the cost ofCCBT and TCBT. It is difficult to draw any firmconclusions about the cost-effectiveness of FFcompared with CBT.

OCDThere are considerable limitations to the modelused to examine the cost-effectiveness of BT Steps.No consideration is given to relapse rates, as theliterature contains little data on them. The healthstate utility values were based on a very indirectmethod and there is considerable uncertainty inthe values used. The response rate came from atrial which again suffers from small numbers.

The cost per patient of BT Steps is significantlyhigher than for the more effective TCBT. Thecost-effectiveness of BT Steps depends on theorganisational level at which the NHS buys alicence. A PCT licence would substantially reducecosts and make it less attractive, although the finalposition also depends on the cost of TCBT.

Need for further researchSeveral key research needs were identified in thisreview. These remain the same as in the previousreview.

The priority areas for research include thefollowing.

● The position of CCBT within a stepped careprogramme needs to be identified as well as itsrelationship to other efforts to increase access toCBT and psychological therapies.

● Research is needed to compare CCBT withother therapies that reduce therapist time, inparticular bibliotherapy.

● Further research is also needed to explore theuse of CCBT via the Internet.

● Research needs to be carried out byindependent researchers. It should be carried

out by those who are not associated withcommercial or product gains.

● Studies of CCBT should be RCTs and need toinclude an ITT analysis to take into accountpatients who drop out of trials. The reasons forwithdrawal from trials need to be identified, asthey relate directly to patient preference.

● Patient preference should be addressed in trialdesign. Two possibilities are the inclusion ofqualitative research methods and the use ofpatient preference trials.

● Research is needed to determine the level oftherapist involvement needed when usingCCBT programmes to produce optimaloutcomes.

● Studies need to be undertaken within the GPsetting, as this is where most patients withanxiety, depression and phobias are treated.

● Efforts should be made to include patients withco-morbidities routinely treated within primarycare.

Other important issues requiring further researchinclude the following.

● The type of patient most likely to benefit fromCCBT needs to be identified, particularly withregard to condition and severity of condition.

● Patients from a variety of ethnic and socio-economic backgrounds must be included instudies, and attention should be paid to ageand gender.

● Co-morbidity and medication must be takeninto account

● Other variables such as chronicity, previoustreatment, social adjustment, interpersonaldifficulties and social circumstances also need tobe considered.

● Further research is needed to determine howpatients with agoraphobia and social phobia,who do not currently access services becausethey are housebound, may benefit from CCBT.

Study design issues include the following.

● Study design should minimise researcherallegiance effects.

● If possible, patients who drop out of trialsshould be asked to complete outcome measuresand reasons for withdrawal from trials should beclearly stated.

● Studies must be designed with adequatestatistical power, taking into account the samplesizes needed to determine equivalent andsuperior effectiveness.

● Studies should use appropriate, well-validatedoutcome measures.

Discussion

58


59


● Studies comparing CCBT with TAU need to bedesigned so that TAU is indeed that and notminimal intervention, to maximise the benefitsassociated with CCBT.

Components of CCBT warranting further researchinclude:

● incorporation of CBT material ● readability and legibility of material● length and frequency of sessions ● amount of homework ● the most appropriate software and computer

interface● comparison of individual CCBT packages to

determine whether one may be more effectivethan others; CCBT packages need to be fullydescribed and categorised to facilitatecomparison

● amount of therapist time required for CCBTpackages to be effective

● use of individual rooms for each patientcompared with multiple user rooms.

Research recommendations for cost-effectivenessinclude:

● larger trials in a variety of settings: it isrecommended that the trials have sufficientnumbers to provide enough power forestimating important differences in both costand effectiveness

● a pragmatic RCT of CCBT in a stepped careprogramme with economic data

● primary data to be collected using genericpreference-based measures in people withdepression and anxiety, panic phobias and OCD, and consideration given topreference-based condition-specific measures to provide a better basis forestimating QALYs for interventions in this area.


61


There is evidence to support the effectiveness ofBtB and FF. There is limited evidence of

poorer quality that Cope and OvercomingDepression are effective. There is no RCTevidence to support the effectiveness of BT Steps.

● There is some evidence that CCBT is aseffective as TCBT for the treatment ofdepression/anxiety and phobia/panic.

● There is some evidence that CCBT is moreeffective than TAU in the treatment ofdepression/anxiety.

● In studies reporting accurate estimates oftherapist time, CCBT appears to reducetherapist time compared with TCBT and istherefore of use where access to TCBT islimited.

Cost-effectivenessReviewsThere was only one published economicevaluation of CCBT, which was an economicevaluation of BtB alongside an RCT. It concludedthat BtB was cost-effective against TAU in terms ofcost per QALY (less than £2000). It had a numberof weaknesses that were addressed in the model.The other submissions contained some cost data,but no other cost-effectiveness studies.

ModellingThe results in terms of incremental cost per QALYcompared with TAU and the likelihood of being

cost-effective at £30,000 per QALY were £1801and 86.8% for BtB, £7139 and 62.6% for Cope,and £5391 and 54.4% for Overcoming Depression.The strength of BtB lies in the fact that it has beenevaluated in the context of an RCT with a controlgroup. The subgroup analysis found no differenceacross the severity groupings.


The incremental cost per QALY of FF overrelaxation was £2380. Its position compared withTCBT is less clear.

The position of BT Steps is even more equivocalbecause there is more uncertainty surrounding thelikely cost of the licence. Midpoint estimatessuggest that BT Steps will be dominated by TCBT,but allowing for a lower cost PCT licence results inthe incremental cost-effectiveness of BT Steps overrelaxation being £15,581 and TCBT over BTSteps being £22,484.

These conclusions are subject to substantialuncertainties around the organisational level forpurchasing these products and the likelythroughput. This is in addition to concerns withthe quality of evidence on response to therapy,longer term outcomes and quality of life.

Chapter 7

Conclusions


63


Special thanks are due to Professor MichaelBarkham for providing EQ-5D data on a

depression sample, Professor Jordi Alonso and theESEMeD group for undertaking additionalanalyses to generate EQ-5D and SF-6D for PanicPhobia and OCD states, Dr Paul McCrone andProfessor Judy Proudfoot for making the datafrom the BtB trial available to the TAR team andGraham Whitfield and his colleagues for makingthe data from their trial of OvercomingDepression available to the TAR team.

Thanks also to Stephen Walters, who providedstatistical advice, and to Gill Rooney for her helpin preparing and formatting the report.

The contents of the report remain theresponsibility of the authors.

Contribution of authorsCatherine Beverley (Systematic ReviewsInformation Officer) undertook the electronicliterature searches. Eva Kaltenthaler (ManagingDirector, ScHARR-TAG), Mike Ferriter (ResearchFellow) and Gill Rooney (Project Administrator)carried out the review of clinical effectiveness foranxiety, depression and phobias. Indra Tumur(Research Fellow) carried out the clinicaleffectiveness review for OCD. John Brazier(Professor of Health Economics) and Enrico deNigris (Research Assistant) carried out theeconomic analysis. Paul Sutcliffe (ResearchAssociate) updated the background chapter.Glenys Parry (Professor of Applied PsychologicalTherapies) provided specialist advice.

Acknowledgements


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1. Biological Abstracts2. CINAHL3. Cochrane Central Database of Controlled

Trials (CENTRAL)4. Cochrane Database of Systematic Reviews

(CDSR)5. EMBASE6. Health Management Information Consortium

(HMIC)7. MEDLINE8. MEDLINE Plus

9. NHS Database of Abstracts of Reviews ofEffectiveness (DARE)

10. NHS Economic Evaluations Database (NHSEED)

11. NHS Health Technology Assessment (HTA)Database

12. Office of Health Economics Health EconomicEvaluations Database (OHE HEED)

13. PsycINFO14. Science Citation Index15. Social Sciences Citation Index

Appendix 1

Electronic bibliographic databases searched


73


1. Agency for Healthcare Research and Quality(AHRQ)

2. Aggressive Research Intelligence Facility(ARIF)

3. British Association for Behavioural andCognitive Psychotherapists (BABCP)

4. Bandolier5. British Psychological Society (BPS)6. Canadian Co-ordinating Centre for Health

Technology Assessment (CCOHTA)7. Centre for Health Economics, University of

York8. Computers in Mental Health9. Current Controlled Trials (CCT)10. Department of Health11. Google12. Health Evidence Bulletins, Wales13. International Network of Agencies for Health

Technology Assessment (INAHTA)Clearinghouse

14. Index to Theses15. Medical Research Council (MRC) Funded

Projects Database

16. National Assembly for Wales (NAfW)17. National Guideline Clearinghouse (NGC)18. National Research Register (NRR)19. National Co-ordinating Centre for Health

Technology Assessment (NCCHTA)20. Organising Medical Networked Information

(OMNI)21. Research Findings Register (ReFeR)22. Royal College of Psychiatrists 23. ScHARR Library Catalogue24. Scottish InterCollegiate Guideline Network

(SIGN)25. Trent Working Group on Acute Purchasing26. Turning Research into Practice (TRIP)

Database27. Wessex Development and Evaluation

Committee (DEC) Reports28. West Midlands Development and Evaluation

Services (DES) Reports29. World Health Organisation (WHO)

Appendix 2

Other sources consulted


75


CDSR and CENTRALOvid, 2004 Issue 1Search undertaken March 2004

1 depression2 exp anxiety/3 exp anxiety disorders/4 (depression or depressive for depressed).tw5 (anxiet$ or anxious).tw6 panic$.tw7 agoraphobi$.tw8 phobi$.tw9 obsessive compulsive disorder/10 (obsess$ and (personalit$ or compuls$)).tw11 or/1-1012 exp psychotherapy/13 (cognitive adj2 therap$).tw14 ((behaviour$ or behavior$) adj2 therap$).tw15 or/12-1416 11 and 1517 exp medical informatics computing/18 multimedia/19 computer-assisted instruction/20 exp decision-making, computer-assisted/21 computer$.tw22 Internet.tw23 interactive voice response.tw24 therapy, computer-assisted/25 or/17-2426 16 and 2527 “beating the blues”.tw28 “overcoming depression”.tw29 “restoring the balance”.tw30 fearfighter.tw31 or/27-3032 26 or 31

CINAHLOvid, 1982–2004Search undertaken March 2004

1 exp depression/2 exp anxiety disorders/

3 exp anxiety/4 (depression or depressed or depressive).tw5 (anxiet$ or anxious).tw6 panic$.tw7 agoraphobi$.tw8 phobi$.tw9 (obsess$ and (personalit$ or compuls$)).tw10 or/1-911 exp psychotherapy/12 ((cognitive or behaviour$ or behavior$) adj2therap$).tw13 or/11-1214 10 and 1315 exp “computers and computerization”/16 exp information systems/17 exp information technology/18 multimedia/19 computer assisted instruction/20 comput$.ti21 interactive voice response.tw22 internet.tw23 exp decision making, computer assisted/24 exp telecommunications/25 (telephone$ or phone$).ti26 or/15-2527 14 and 2628 “beating the blues”.tw29 “overcoming depression”.tw30 “restoring the balance”.tw31 “fearfighter”.tw32 or/28-3233 27 or 32

CRD databases (NHS DARE, EED,HTA)CRD website: complete databasesSearch undertaken March 2004

depress or anxiety or anxious or panic oragoraphobi or phobi or obsessive or compulsive/all fields AND psychotherapy or cognitive orbehavior or behaviour/ all fields

Appendix 3

Search strategies used in the major electronic bibliographic databases

EMBASESilverPlatter WebSPIRS, 1980–2004Search undertaken March 2004

#1 ‘depression-‘ / all subheadings#2 ‘anxiety-‘ / all subheadings#3 explode ‘anxiety-neurosis’ / all subheadings#4 explode ‘phobia-‘ / all subheadings#5 (depression or depressed or depressive) in ti,ab#6 (anxiet* or anxious) in ti, ab#7 panic* in ti, ab#8 phobi* in ti, ab#9 agoraphobi* in ti, ab#10 (obsess* and (personalit* or compuls*)) in ti,ab#11 #1 or #2 or #3 or #4 or #5 or #6 or #7 or#8 or #9 or #10#12 explode ‘psychotherapy-‘ / all subheadings#13 (cognitive near2 therap*) in ti, ab#14 ((behaviour* or behavior*) near2 therap*) inti, ab#15 #12 or #13 or #14#16 #11 and #15#17 explode ‘computer-‘ / all subheadings#18 explode ‘automation-computers-and-data-processing’ / all subheadings#19 comput* in ti#20 interactive voice response in ti, ab#21 ‘telephone-‘ / all subheadings#22 (telephone* or phone*) in ti#23 internet in ti, ab#24 #17 or #18 or #19 or #20 or #21 or #22 or#23#25 #16 and #24#26 beating the blues#27 overcoming depression#28 restoring the balance#29 fearfighter#30 #26 or #27 or #28 or #29#31 #25 or #30

OHE HEEDCD-ROM versionSearch undertaken March 2004

Search terms:● (depress* or anxi* or panic* or

agoraphobi* or obsessive or compulsive) and(cognitive or behavi* or therap* orpsychotherap*)

Fields searched:● All data

MEDLINEOvid, 1966–2004Search undertaken January and March 2004

1 depression2 exp anxiety/3 exp anxiety disorders/4 (depression or depressive for depressed).tw5 (anxiet$ or anxious).tw6 panic$.tw7 agoraphobi$.tw8 phobi$.tw9 obsessive compulsive disorder/10 (obsess$ and (personalit$ or compuls$)).tw11 or/1-1012 exp psychotherapy/13 (cognitive adj2 therap$).tw14 ((behaviour$ or behavior$) adj2 therap$).tw15 or/12-1416 11 and 1517 exp medical informatics computing/18 multimedia/19 computer-assisted instruction/20 exp decision-making, computer-assisted/21 computer$.tw22 Internet.tw23 interactive voice response.tw24 therapy, computer-assisted/25 or/17-2426 16 and 2527 “beating the blues”.tw28 “overcoming depression”.tw29 “restoring the balance”.tw30 fearfighter.tw31 or/27-3032 26 or 3133 bibliotherapy/34 bibliotherap$.tw35 or/33-3436 16 and 3537 32 or 36

PsycINFOSilverPlatter, 1967–2004Search undertaken March 2004

#1 explode ‘affective-disorders’ in de#2 explode ‘anxiety-disorders’ in de#3 explode ‘anxiety-‘ in de#4 ‘anxiety-management’ in de#5 explode ‘phobias-‘ in de#6 ‘panic-disorder’ in de#7 (depression or depressed or depressive) in ti,ab

Appendix 3

76


77


#8 (anxiet* or anxious) in ti, ab#9 panic* in ti, ab#10 agoraphobi* in ti, ab#11 phobi* in ti, ab#12 (obsess* and (personalit* or compuls*)) in ti,ab#13 #1 or #2 or #3 or #4 or #5 or #6 or #7 or#8 or #9 or #10 or #11 or #12#14 explode ‘psychotherapy-‘ in de#15 explode ‘cognitive-techniques’ in de#16 (cognitive near2 therap*) in ti, ab#17 ((behaviour* or behavior*) near2 therap*) inti, ab#18 #14 or #15 or #16 or #17#19 #13 and #18#20 explode ‘computers-‘ in de#21 explode ‘computer-applications’ in de#22 explode ‘computer-software’ in de#23 ‘computer-programming’ in de#24 ‘human-computer-interaction’ in de#25 computer* in ti, ab#26 internet in ti, ab, de#27 interactive voice response* in ti, ab#28 #20 or #21 or #22 or #23 or #24 or #25 or#26 or #27

#29 #19 and #28#30 beating the blues#31 overcoming depression#32 restoring the balance#33 fearfighter#34 #30 or #31 or #32 or #33#35 #29 or #34

Science and Social SciencesCitation IndexWeb of Science, 1981–2004Search undertaken March 2004

TI=((depress* or anxiet* or panic* or phobi* oragoraphobi* or obsessive or compulsive) and(comput* or multimedia or internet or interactivevoice response or telephone* or phone* oraudio)); DocType=All document types;Languages=All languages; Databases=SCI-EXPANDED, SSCI; Timespan=All Years


79


Economic evaluations1 economics/2 exp “costs and cost analysis”/3 economic value of life/4 exp economics, hospital/5 exp economics, medical/6 economics, nursing/7 economics, pharmaceutical/8 exp models, economic/9 exp “fees and charges”/10 exp budgets/11 ec.fs12 (cost or costs or costed or costly or costing$).tw13 (economic$ or pharmacoeconomic$ or price$or pricing).tw14 or/1-13

Quality of life1 exp quality of life/2 quality of life.tw3 life quality.tw4 hql.tw5 (sf 36 or sf36 or sf thirtysix or sf thirty six orshort form 36 or short form thirty six or shortform thirty six or shortform 36).tw

6 qol.tw7 (euroqol or eq5d or eq 5d).tw8 quality adjusted life$.tw9 (qaly$ or qald$ or qale$ or qtime$).tw10 hye$.tw11 health$ year$ equivalent$.tw12 health utilit$.tw13 hui.tw14 quality of wellbeing$.tw15 quality of well being.tw16 qwb.tw17 or/1-16

Economic models1 exp models, economic/2 *models, theoretical/3 *models, organisational/4 economic model$.tw5 markov chains/6 markov$.tw7 monte carlo method/8 monte carlo.tw9 exp decision theory/10 (decision$ adj2 (tree$ or analy$ or model$)).tw

Appendix 4

Economic evaluations, quality of life and economic models methodological search filters used in

MEDLINE (Ovid) 1966 to March 2004


81


Reviews or descriptionsAckermann RT, Williams J. Rational treatment choicesfor non-major depressions in primary care: an evidence-based review. J Gen Intern Med 2002;17:293–301.

Altshuler LL, Cohen LS, Moline ML, Kahn DA,Carpenter D, Docherty JP, et al. Expert consensusguidelines for the treatment of depression in women: a new treatment tool. Economics of Neuroscience 2001;3(6):48–61.

Anderson PL, Rothbaum BO, Hodges L. Virtual reality:using the virtual world to improve quality of life in thereal world. Bull Menninger Clin 2001;65:78–91.

Andersson G, Carlbring P. Internet and cognitivebehaviour therapy: new opportunities for treatment andassessment. Cognitive Behaviour Therapy 2003;32:97–9.

Andrews G, Erskine A. Reducing the burden of anxietyand depressive disorders: the role of computerizedclinician assistance. Current Opinion in Psychiatry 2003;16:41–4.

Anon. Improving the recognition and management ofdepression in primary care. Effective Health Care 2002;7:1–11.

Bai YM, Lin CC, Chen JY, Liu WC. Virtual psychiatricclinics [6]. Am J Psychiatry 2001;158:1160–1.

Bower P, Richards D, Lovell K. The clinical and cost-effectiveness of self-help treatments for anxiety anddepressive disorders in primary care: a systematicreview. Br J Gen Pract 2001;51:838–45.

Christensen H, Griffiths KM. The prevention ofdepression using the Internet. Med J Aust 2002;177(Suppl):S122–5.

Churchill R, Hunot V, Corney R, Knapp M, McGuire H,Tylee A, et al. A systematic review of controlled trials ofthe effectiveness and cost-effectiveness of briefpsychological treatments for depression. Health TechnolAssess 2001;5(35).

Freudenstein U, Jagger C, Arthur A, Donner BN.Treatments for late life depression in primary care – asystematic review. Fam Pract 2001;18:321–7.

Gega L, Marks I. Computer-aided CBT self-help foranxiety and depressive disorders: experience of aLondon clinic and future directions. J Clin Psychol 2004;60:147–57.

Gould RA. A meta-analysis of treatment outcome forpanic disorder. Clin Psychol Rev 1995;15:819–44.

Heimberg RG. Current status of psychotherapeuticinterventions for social phobia. J Clin Psychiatry 2001;62(Suppl 1):36–42.

Heimberg RG, Coles ME. Reflections on innovations incognitive behavioral treatments of anxiety disorders.Cognitive and Behavioral Practice 1999;6:258–63.

Kennedy SH, Lam RW, Morris B. Clinical guidelines fordepressive disorders: summary of recommendationsrelevant to family physicians. Can Fam Physician 2003;49:489–91.

Lloyd MG, Schlosser B, Stricker G. Case vignette:cybertherapy. Ethics and Behavior 1996;6:169–77.

McKendree-Smith NL, Floyd M, Scogin FR. Self-administered treatments for depression: a review. J ClinPsychol 2003;59:275–88.

Marks I. Potential of computer aids in mental healthcare. Br J Psychiatry (in press).

Marks IM. The maturing of therapy. Some briefpsychotherapies help anxiety/depressive disorders butmechanisms of action are unclear. Br J Psychiatry 2002;180:200–4.

Muhlberger A, Herrmann MJ, Wiedemann GC, Ellgring H, Pauli P. Repeated exposure of flight phobicsto flights in virtual reality. Behav Res Ther 2001;39:1033–50.

Newman MG. The clinical use of palmtop computers inthe treatment of generalized anxiety disorder. Cognitiveand Behavioral Practice 1999;6:222–34.

Newman MG, Erickson T, Przeworski A, Dzus E. Self-help and minimal-contact therapies for anxietydisorders: is human contact necessary for therapeuticefficacy? J Clin Psychol 2003;59:251–74.

Pampallona S, Bollini P, Tibaldi G, Kupelnick B,Munizza C. Patient adherence in the treatment ofdepression. Br J Psychiatry 2002;180(FEB):104–9.

Pomerantz JM. Clinical responsibility and E-therapy.Drug Benefit Trends 2002;14:29–30.

Proulx K. Integrating mindfulness-based stressreduction. Holistic Nursing Practice 2003;17:201–8.

Richards J, Klein B, Carlbring P. Internet-basedtreatment for panic disorder. Cognitive Behaviour Therapy2003;32:125–35.

Rush AJ, Trivedi M, Fava M. Depression, IV: STAR*Dtreatment trial for depression. Am J Psychiatry2003;160:237.

Appendix 5

Excluded studies

Taylor CB, Luce KH. Computer- and Internet-basedpsychotherapy interventions. Current Directions inPsychological Science 2003;12:18–22.

Van Balkom AJLM, Spinhoven P, Bakker A, Rammeloo KC, Graatsma AT, Adriaanse MTh, et al. Panic-free status is not associated withimprovement on continuous measures in panic disorder.Journal of Nervous and Mental Disease 2000;188:840–2.

Van Schaik DJF, Van Marwijk HWJ, Van Der WindtDAWM, Beekman ATF, De H, et al. Effectiveness ofpsychotherapy for depressive disorder in primary care.A systematic review. Tijdschrift voor Psychiatrie2002;44:609–19.

Vincelli F, Choi YH, Molinari E, Wiederhold BK, Riva G.A VR-based multicomponent treatment for panicdisorders with agoraphobia. Studies in Health Technologyand Informatics 2001;81:544–50.

Whitfield G, Williams C. Computer-assisted CBT: an option for primary care? 2003 URL:http://www.calipso.co.uk/downloads/Articles/Computer_CBT_primarycare.pdf

Wiederhold BK, Jang DP, Gevirtz RG, Kim SI, Kim IY,Wiederhold MD. The treatment of fear of flying: acontrolled study of imaginal and virtual reality gradedexposure therapy. IEEE Trans Inf Technol Biomed 2002;6:218–23.

Williams C. Use of written cognitive-behavioural therapyself-help materials to treat depression. Advances inPsychiatric Treatment 2001;7:233–40.

Williams C, Whitfield G. Written and computer-basedself-help treatments for depression. Br Med Bull 2001;57:133–44.

Zamorski MA, Albucher RC. What to do when SSRIsfail: eight strategies for optimizing treatment of panicdisorder. Am Fam Physician 2002;66:1477–84.

Zuckerman E. Finding, evaluating, and incorporatingInternet self-help resources into psychotherapy practice.[review] J Clin Psychol 2003;59:217–25.

Cost-effectiveness studiesAntonuccio DO. A cost-effectiveness analysis of cognitivebehavior therapy and fluoxetine (Prozac) in thetreatment of depression. Behavior Therapy 1997;28:187–210.

Bower P, Byford S, Sibbald B, Ward E, King M, Lloyd M,et al. Randomised controlled trial of non-directivecounselling, cognitive-behaviour therapy, and usualgeneral practitioner care for patients with depression.II: Cost effectiveness. BMJ 2000;321:1389–92.

Byford S, Bower P. Cost-effectiveness of cognitive-behavioral therapy for depression: current evidence andfuture research priorities. Expert Review ofPharmacoeconomics and Outcomes Research 2002;2:457–65.

Gibbons RD. Mixed-effects models for mental healthservices research. Health Services and Outcomes ResearchMethodology 2000;1:91–129.

Schulberg HC, Raue PJ, Rollman BL. The effectivenessof psychotherapy in treating depressive disorders inprimary care practice: clinical and cost perspectives. Gen Hosp Psychiatry 2002;24:203–12.

Scott J, Palmer S, Paykel E, Teasdale J, Hayhurst H. Use of cognitive therapy for relapse prevention inchronic depression: cost-effectiveness study. Br JPsychiatry 2003;182:221–7.

Studies not CCBTBillipp SH. The psychosocial impact of interactivecomputer use within a vulnerable elderly population: areport on a randomized prospective trial in a homehealth care setting. Public Health Nurs 2001;18:138–45.

Datto CJ, Thompson R, Horowitz D, Disbot M, OslinDW. The pilot study of a telephone disease managementprogram for depression. Gen Hosp Psychiatry 2003;25:169–77.

Miller L, Weissman M. Interpersonal psychotherapydelivered over the telephone to recurrent depressives apilot study. Depress Anxiety 2002;16:114–17.

Simpson S, Corney R, Fitzgerald P, Beecham J. Arandomised controlled trial to evaluate the effectivenessand cost-effectiveness of counselling patients withchronic depression. Health Technol Assess 2000;4(36):1–4,15–47.

ProtocolsBennett M. The effectiveness of Beating the Blues: acomputer-based treatment for anxiety and depression inprimary care. Thames Valley Primary Care ResearchPartnership, 2004.

Blackburn K. An evaluation of the clinical effectivenessof the Beating the Blues computer based service-usertreatment program, with a cohort of secondary andprimary care service-users within East CommunityMental Health Team (CMHT). Doncaster and SouthHumber Healthcare NHS Trust, 2004.

Hurn K. The effectiveness of Beating the Blues: acomputer-based treatment for anxiety and depression.Gwent Healthcare NHS Trust, 2004.

Leibowitz J. Use of facilitated self-help for the treatmentof anxiety and depression in primary care – comparisonof computerised CBT and a self-help manual. Anexploratory study. Camden and Islington Mental HealthTrust, 2004

Neal M. Computer assisted self-help materials for thetreatment of depression. Cochrane Database Syst Rev2003;3.

OtherChristensen H, Griffiths KM, Korten A. Web-basedcognitive behavior therapy: analysis of site usage andchanges in depression and anxiety scores. J Med Internet

Appendix 5

82

Res 2000;4:e3-Mar. [Description of website usage, not atrial.]

Dunn G, Maracy M, Dowrick C, Ayuso-Mateos JL,Dalgard OS, Page H, et al., ODIN Group. Estimatingpsychological treatment effects from a randomisedcontrolled trial with both non-compliance and loss tofollow-up. Br J Psychiatry 2003;183:323–31. [Analysis ofsome trial components.]

Gilroy LJ, Kirkby KC, Daniels BA, Menzies RG,Montgomery IM. Controlled comparison of computer-aided vicarious exposure versus live exposure in thetreatment of spider phobia. Behavior Therapy2000;31:733–44. [Preliminary trial results, replaced bylater Gilroy study.]

Gruber K, Moran PJ, Roth WT, Taylor CB. Computer-assisted cognitive behavioral group therapy for socialphobia. Behavior Therapy 2001;32:155–65. [Treatmentadjunct.]

Keaverny E, Blackburn K. A survey of East Primary Caretrust general practitioners’ views, about their use of‘Beating the Blues’ computer based service-usertreatment program. 2004. [Unpublished, smalldescription of some components of a trial.]

Kenardy JA, Dow MGT, Johnston DW, Newman MG,Thomson A, Taylor CB. A comparison of deliverymethods of cognitive-behavioral therapy for panicdisorder: an international multicenter trial. J ConsultClin Psychol 2003;71:1068–75. [Treatment adjunct study.]

McDonough M, Marks IM. Teaching medical studentsexposure therapy for phobia/panic – randomized,controlled comparison of face-to-face tutorial in smallgroups vs. solo computer instruction. Med Educ 2002;36:412–17. [Not patients.]

Richards JC, Alvarenga ME. Extension and replicationof an internet-based treatment program for panicdisorder. Cognitive Behaviour Therapy 2002;31:41–7. [No comparator.]

Small DK. The development of Christian-orientedcomputer-assisted cognitive therapy: a pilot study.Dissertation Abstracts International: Section B: The Sciencesand Engineering 2003;63(7-B):3492. [Not an RCT.]

Studies from last reviewBowers W, Stuart S, MacFarlane R, Gorman L. Use ofcomputer administered cognitive behavior therapy withdepressed inpatients. Depression 1993;1:294–9.

Carr AC, Ghosh MD, Marks IM. Computer-supervisedexposure treatment for phobias. Can J Psychiatry 1988;33:112–17.

Ghosh A, Marks IM, Carr AC. Therapist contact andoutcome of self-exposure treatment for phobias. Br JPsychiatry 1988;152:234–8.

Grime PR. An open, randomised study, to compare the effectsof a computerised cognitive behavioural therapy programme(Beating the Blues) plus conventional care, vs conventional

care alone, on absence from work due to anxiety, depression orstress. An attempt to evaluate a workplace intervention forstress. London: Faculty of Occupational Medicine, RoyalCollege of Physicians; 2001.

Jones RB, Kamarzaman Z, Naven LM, Morton WR,Marriott C, Craig N, et al. Cognitive behaviouralcomputer therapy for anxiety: difficulties in carryingout a randomised trial and lessons learned. 2001.Unpublished.

Klein B, Richards JC. A brief internet-based treatmentfor panic disorder. Behavioural and Cognitive Psychotherapy2001;1:113–17.

Newman MG. Comparison of palmtop-computer-assisted brief cognitive-behavioural treatment tocognitive-behavioural treatment for panic disorder. J Consult Clin Psychol 1997;65:178–83.

Newman MG, Kenardy J, Herman S, Barr Taylor C. The use of hand-held computers as an adjunct tocognitive behavior therapy. Computers in Human Behavior1996;12:135–43. [Treatment adjunct.]

Newman MG, Consoli AJ, Taylor CB. A palmtopcomputer program for the treatment of generalizedanxiety disorder. Behav Modif 1999;23:597–619.[Treatment adjunct.]

Proudfoot J, Goldberg D, Mann A, Everitt B, Marks I,Gray JA. Computerized, interactive, multimediacognitive-behavioural program for anxiety anddepression in general practice [see comment]. PsycholMed 2003;33:217–27.

Proudfoot J, Swain S, Widmer S, Watkins E, Goldberg D,Marks I, et al. The development and beta-test of acomputer-therapy program for anxiety and depression:hurdles and lessons. Computers in Human Behavior2003;19:277–89.

Selmi PM, Klein MH, Greist JH, Sorrell SP, Erdman HP.Computer-administered cognitive-behavioural therapyfor depression. Am J Psychiatry 1990;147:51–6.

Shaw SC, Marks IM, Toole S. Lessons from pilot tests ofcomputer self-help for agora/claustrophobia and panic.MD Computing 1999;16:44-48.

Smith KL, Kirkby KC, Montgomery IM, Daniels BA.Computer-delivered modeling of exposure for spiderphobia: relevant versus irrelevant exposure. J AnxietyDisord 1997;11:489–97.

White J, Jones R, McGarry E. Cognitive behaviouralcomputer therapy for the anxiety disorders: a pilotstudy. Journal of Mental Health 2000;9:505–16.

Wright JH, Wright AS, Basco MR, Albano AM, Raffield T,Goldsmith J, et al. Controlled trial of computer-assistedcognitive therapy for depression. World Congress ofCognitive Therapy, 2001, Conference Proceedings.

Wright JH, Wright AS, Salmon P, Beck AT, Kuykendall J,Goldsmith LJ, et al. Development and initial testing of amultimedia program for computer-assisted cognitivetherapy. Am J Psychother 2002;56:76–86. [Treatmentadjunct.]


83



85


This appendix contains the evidence tables with data extracted from the 19 studies included in thisupdate. RCTs and non-randomised trials are presented in separate tables. Depression/anxiety studies

are listed first followed by phobia/panic studies. Studies of the included CCBT software packages arelisted first within these categories, followed by other studies of either depression/anxiety or phobia/panic.

Appendix 6

Evidence tables for depression/anxiety and phobia/panic studies

Appendix 6

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eriv

ed

RCT

Pani

c di

sord

er

Alle

rgy

Rese

arch

, Boë

thiu

s Fo

unda

tion,

Sw

edish

Cou

ncil

from

sel

f-he

lp b

ooks

for

Rese

arch

in t

he H

uman

ities

and

Soc

ial S

cien

ces,

and

Sö

ders

tröm

-Kön

iska

Foun

datio

n

Fras

er, 2

00198

NR

CAV

E fo

r sp

ider

pho

bia

RCT

Spec

ific

phob

ia(s

pide

rs)

Gilr

oy, 2

000,

107

Gilr

oy, 2

00399

NR

CAV

E fo

r sp

ider

pho

bia

RCT

Spec

ific

phob

ia(s

pide

rs)

Hea

ding

, 200

1101

NR

Prol

onge

d sin

gle

sess

ion

of C

AVE

for

RCT

Spec

ific

phob

ia

spid

er p

hobi

a(s

pide

rs)

[Com

mer

cial

-in-c

onfid

ence

info

rmat

ion

has

been

rem

oved

.]

Appendix 6

88 TA

BLE

21

Stud

y ch

arac

teris

tics:

RCT

s

Stud

yD

escr

ipti

on o

f CC

BT

Stud

y qu

alit

yC

o-th

erap

y or

med

icat

ion

Com

para

tor

Sam

ple

size

Dep

ress

ion/

anxi

ety:

incl

uded

pac

kage

s

Prou

dfoo

t,20

0487

BtB

Met

hod

of r

ando

misa

tion:

seal

ed e

nvel

opes

, str

atifi

ed fo

rm

edic

atio

n an

d du

ratio

n of

curr

ent

episo

de; n

o bl

inde

das

sess

men

t; po

wer

cal

cula

tion

repo

rted

; los

s to

follo

w-u

p an

dso

me

reas

ons

repo

rted

Not

cur

rent

ly r

ecei

ving

any

psyc

holo

gica

l tre

atm

ent

orco

unse

lling

; 119

pat

ient

s us

ing

med

icat

ion

TAU

502

patie

nts

wer

e as

sess

ed,

406

of w

hom

wer

e su

itabl

e fo

rin

clus

ion.

132

of t

hese

decl

ined

to

part

icip

ate,

leav

ing

274

to b

egin

the

tria

l: 14

6 in

the

BtB

grou

p an

d 12

8 in

the

TAU

gro

up

Dep

ress

ion/

anxi

ety:

oth

ers

cont

inue

d

Chr

isten

sen,

2004

95M

oodG

ym o

ffers

CBT

for

the

prev

entio

n of

dep

ress

ion

Met

hod

of r

ando

misa

tion:

com

pute

r pr

ogra

mm

efu

nctio

n; n

o bl

inde

das

sess

men

t; po

wer

cal

cula

tion

repo

rted

; los

s of

follo

w-u

p an

dre

ason

s re

port

ed

Non

e of

the

par

ticip

ants

was

rece

ivin

g cl

inic

al c

are

from

aps

ycho

logi

st o

r ps

ychi

atris

t; no

info

rmat

ion

on m

edic

atio

nre

port

ed

1. W

eb-b

ased

pro

gram

me,

Blue

Page

s, w

hich

pro

vide

sde

pres

sion

liter

acy,

offe

ring

evid

ence

-bas

ed in

form

atio

n.2.

Con

trol

gro

up, ‘

atte

ntio

npl

aceb

o’: t

elep

hone

d on

ce a

wee

k by

inte

rvie

wer

s to

disc

uss

lifes

tyle

and

envi

ronm

enta

l fac

tors

525

wer

e ra

ndom

ised,

182

inth

e M

oodG

ym g

roup

, 165

inBl

uePa

ges

and

178

in t

heco

ntro

l gro

up

Cla

rke,

200

297In

tern

et-b

ased

inte

rven

tion

focu

sing

on c

ogni

tive

rest

ruct

urin

g te

chni

ques

adap

ted

from

CBT

man

uals

Eigh

t se

ctio

ns c

over

ing

info

rmat

ion

on d

epre

ssio

n,th

roug

h pr

oces

ses

and

prac

tical

exe

rcise

s

Met

hod

of r

ando

misa

tion:

rand

om a

ssig

nmen

t al

gorit

hmen

code

d in

web

site

prog

ram

me;

no

blin

ded

asse

ssm

ent;

pow

er c

alcu

latio

nre

port

ed; l

oss

to fo

llow

-up

repo

rted

but

not

rea

sons

Prov

ided

for

the

perio

d of

12

mon

ths

afte

r ra

ndom

isatio

n.In

the

CC

BT g

roup

: 55.

1% m

ade

men

tal h

ealth

out

patie

nt v

isits

;16

.3%

wer

e di

spen

sed

TCA

s,47

.1%

SSR

Is, 2

0% b

upro

pion

,5.

6% li

thiu

m c

arbo

nate

, 20.

4%be

nzod

iaze

pine

and

2.8

%ve

nlaf

axin

e. T

he c

ompa

rabl

efig

ures

for

the

cont

rol g

roup

wer

e: 4

8.3%

mad

e m

enta

l hea

lthou

tpat

ient

visi

ts; 1

0.5%

wer

edi

spen

sed

TCA

s; 4

9.0%

SSR

Is,

15.9

% d

ispen

sed

bupr

opio

n,3.

2% li

thiu

m c

arbo

nate

, 24.

1%be

nzod

iaze

pine

and

8.5

%ve

nlaf

axin

e. A

ll pa

rtic

ipan

ts w

ere

free

to

obta

in u

sual

car

e fo

rde

pres

sion

No

acce

ss t

o O

DIN

site

but

acce

ss t

o no

n-in

tera

ctiv

ew

ebsit

e pr

ovid

ing

info

rmat

ion

on a

ran

ge o

f hea

lth c

once

rns

incl

udin

g de

pres

sion

and

usua

lca

re

526

initi

ally

acc

esse

d th

e st

udy

web

site

and

299

com

plet

edba

selin

e as

sess

men

t; 14

4 w

ere

rand

omise

d to

OD

IN (1

16w

ere

in t

he d

epre

ssio

n gr

oup)

and

155

to u

sual

car

e co

ntro

lgr

oup

(107

wer

e in

the

depr

essio

n gr

oup)


89


TA

BLE

21

Stud

y ch

arac

teris

tics:

RCT

s (c

ont’d

)

Stud

yD

escr

ipti

on o

f CC

BT

Stud

y qu

alit

yC

o-th

erap

y or

med

icat

ion

Com

para

tor

Sam

ple

size

Pho

bia/

pani

c: in

clud

ed s

tudi

es

Mar

ks, 2

00488

FFM

etho

d of

ran

dom

isatio

n:op

aque

sea

led

enve

lope

s in

thre

e se

ts, o

ne p

er p

hobi

aty

pe; a

sses

sors

blin

ded;

pow

erca

lcul

atio

n re

port

ed; l

oss

tofo

llow

-up

repo

rted

and

reas

ons

mos

tly r

epor

ted

Nin

e pa

tient

s (1

1%) w

ere

onTC

As,

five

(6%

) on

an S

RI, t

wo

(3%

) on

othe

r an

tidep

ress

ants

and

four

(5%

) on

benz

odia

zepi

nes;

52

had

seen

ahe

alth

care

pro

fess

iona

l for

the

irpr

oble

m in

the

pas

t 3

mon

ths

1. S

elf-

expo

sure

the

rapy

with

a cl

inic

ian

2. C

ompu

ter-

guid

ed s

elf-

rela

xatio

n

129

wer

e in

itial

ly s

cree

ned,

94

wer

e el

igib

le, o

ne r

efus

ed,

leav

ing

93 p

atie

nts

who

wer

era

ndom

ised.

FF

gro

upn

= 3

7; c

linic

ian

grou

p n

= 3

9 an

d re

laxa

tion

grou

p n

= 1

7; o

f the

se, d

ata

wer

e lo

st fo

r th

ree

patie

nts,

so

thes

e pa

tient

s w

ere

excl

uded

from

dat

a an

alys

is

Pho

bia/

pani

c: o

ther

stu

dies

Car

lbrin

g,20

0192

The

pro

gram

me

cons

ists

of s

ixm

odul

es: p

sych

oedu

catio

n,br

eath

ing

retr

aini

ng, t

houg

htpr

oces

ses

in r

elat

ion

toan

xiet

y, in

tero

cept

ive

expo

sure

, exp

osur

e in

vivo

and

rela

pse

prev

entio

n. E

ach

mod

ule

ends

with

que

stio

ns t

obe

ans

wer

ed a

nd e

-mai

led

toan

ass

esso

r to

judg

e w

heth

erth

e pa

rtic

ipan

t is

read

y to

mov

e on

to

the

next

mod

ule

Met

hod

of r

ando

misa

tion:

pairw

ise d

raw

ing

of lo

ts; n

obl

inde

d as

sess

men

t; no

pow

erca

lcul

atio

n re

port

ed; l

oss

tofo

llow

-up

and

reas

ons

fully

repo

rted

37%

had

not

pre

viou

slyre

ceiv

ed a

ny t

reat

men

t fo

r th

eir

PD. 6

4% w

ere

taki

ngps

ycho

activ

e m

edic

atio

n du

ring

the

stud

y, t

he m

ajor

ity (4

4%)

taki

ng S

SRIs

. One

par

ticip

ant

was

rec

eivi

ng p

sych

odyn

amic

ther

apy

WLC

500

com

plet

ed t

he a

pplic

atio

nfo

rm; 4

1 pa

rtic

ipan

ts m

et t

hein

clus

ion

crite

ria, 1

0 of

who

mdi

d no

t co

mpl

ete

base

line

mea

sure

men

ts a

nd fi

vew

ithdr

ew a

fter

rand

omal

loca

tion

Schn

eide

r,20

0590

FFM

etho

d of

ran

dom

isatio

n:op

aque

sea

led

enve

lope

s in

the

requ

ired

2:1

ratio

,st

ratif

ied

for

phob

ia t

ype;

asse

ssor

s bl

inde

d; p

ower

calc

ulat

ion

repo

rted

; los

s to

follo

w-u

p an

d re

ason

sre

port

ed

19 o

n an

SSR

I, six

on

anot

her

antid

epre

ssan

t, ni

ne o

n a

seda

tive,

six

on

a �

-blo

cker

and

two

on a

n an

tipsy

chot

ic

MA

: net

-gui

ded

min

imal

CBT

incl

udin

g re

laxa

tion

but

excl

udin

g ex

posu

re, i

nclu

ding

mos

t of

the

Bal

ance

sys

tem

,us

ed fo

r de

pres

sion/

anxi

ety

94 a

pplie

d, 7

9 w

ere

scre

ened

,68

wer

e su

itabl

e an

d w

ere

rand

omise

d, 4

5 to

FF

and

23to

MA

cont

inue

d

Appendix 6

90 TA

BLE

21

Stud

y ch

arac

teris

tics:

RCT

s (c

ont’d

)

Stud

yD

escr

ipti

on o

f CC

BT

Stud

y qu

alit

yC

o-th

erap

y or

med

icat

ion

Com

para

tor

Sam

ple

size

Car

lbrin

g,20

0394

As

abov

e in

Car

lbrin

g92M

etho

d of

ran

dom

isatio

n: t

rue

rand

om n

umbe

r se

rvic

e; n

obl

inde

d as

sess

men

t; no

pow

erca

lcul

atio

n re

port

ed; l

oss

tofo

llow

-up

and

reas

ons

repo

rted

In t

he C

CBT

gro

up 3

6.4%

wer

eta

king

SSR

Is, 1

8.2%

benz

odia

zepi

nes,

36.

4% T

CA

s,9.

1% �

-blo

cker

s an

d 9.

1%ps

ycho

ther

apy.

In t

he c

ontr

ol g

roup

63.

6%w

ere

taki

ng S

SRIs

, 27.

3%be

nzod

iaze

pine

s, 9

.1%

TC

As,

0% �

-blo

cker

s an

d 18

.2%

psyc

hoth

erap

y

AR:

nin

e m

odul

es o

nre

laxa

tion

and

rela

pse

prev

entio

n

53 p

eopl

e w

ere

inte

rvie

wed

initi

ally,

of w

hom

22

fulfi

lled

the

incl

usio

n cr

iteria

, 11

inea

ch g

roup

Car

lbrin

g,20

0496

Ten

mod

ules

incl

udin

gin

form

atio

n ex

erci

ses

and

essa

y qu

estio

ns, s

imila

r to

abov

e in

Car

lbrin

g.92

Met

hod

of r

ando

misa

tion:

tru

era

ndom

num

ber

serv

ice;

no

blin

ded

asse

ssm

ent;

no p

ower

calc

ulat

ion

repo

rted

; los

s to

follo

w-u

p an

d re

ason

sre

port

ed

In t

he C

CBT

gro

up 3

6% w

ere

taki

ng S

SRIs

, 4%

benz

odia

zepi

nes,

4%

TC

As

and

8% �

-blo

cker

s. In

the

con

trol

grou

p 25

% w

ere

taki

ng S

SRIs

,12

.5%

ben

zodi

azep

ines

, 8.3

%TC

As

and

4% �

-blo

cker

s

Trea

tmen

t w

ith t

hera

pist

simila

r to

the

con

tent

of t

heC

CBT

pro

gram

me

(TC

BT)

Initi

ally

427

com

plet

ed t

heco

mpu

teris

ed in

terv

iew

and

363

wer

e ex

clud

ed (r

easo

nsgi

ven)

. 64

peop

le w

ere

calle

dto

an

in-p

erso

n in

terv

iew

, of

who

m 5

9 w

ere

inte

rvie

wed

.Te

n w

ere

excl

uded

ow

ing

to a

diag

nosis

oth

er t

han

PD.

49 p

eopl

e pa

rtic

ipat

ed in

the

stud

y, 2

5 in

the

CC

BT g

roup

and

24 in

the

con

trol

gro

up

Fras

er, 2

00198

Part

icip

ants

are

ask

ed t

o as

sist

an a

nim

ated

scr

een

figur

e to

over

com

e hi

s/he

r fe

ar o

fsp

ider

s us

ing

a po

int-

and-

clic

kte

chni

que

to m

ove

the

figur

eth

roug

h va

rious

exp

osur

esc

enar

ios.

The

pro

gram

me

has

four

leve

ls: e

xpos

ure

to s

pide

rpi

ctur

e, p

last

ic s

pide

r, de

adsp

ider

and

live

spi

der.

The

re is

an o

n-sc

reen

anx

iety

‘ther

mom

eter

’

Met

hod

of r

ando

misa

tion:

NR;

no b

linde

d as

sess

men

t; no

pow

er c

alcu

latio

n re

port

ed;

loss

to

follo

w-u

p an

d re

ason

sre

port

ed, b

ut d

ropo

uts

wer

ere

plac

ed w

ith n

ew p

atie

nts

and

not

clea

r as

to

how

the

yw

ere

chos

en

NR

Two

grou

ps o

f CAV

E w

ere

com

pare

d in

thi

s tr

ial:

thre

e se

ssio

ns v

s six

ses

sions

39 p

rese

nted

for

asse

ssm

ent

and

the

first

30

mee

ting

diag

nost

ic c

riter

ia w

ere

incl

uded

, 15

in t

he t

hree

-se

ssio

n gr

oup

and

15 in

the

six

ses

sion

grou

p

cont

inue

d


91


TA

BLE

21

Stud

y ch

arac

teris

tics:

RCT

s (c

ont’d

)

Stud

yD

escr

ipti

on o

f CC

BT

Stud

y qu

alit

yC

o-th

erap

y or

med

icat

ion

Com

para

tor

Sam

ple

size

Gilr

oy, 2

000,

107

Gilr

oy, 2

00399

As

desc

ribed

in F

rase

r98M

etho

d of

ran

dom

isatio

n: n

otre

port

ed; b

linde

d as

sess

men

tw

as u

nder

take

n; p

ower

calc

ulat

ion

not

repo

rted

; los

sto

follo

w-u

p an

d re

ason

sre

port

ed, b

ut d

ropo

uts

wer

ere

plac

ed w

ith n

ew p

atie

nts

and

not

clea

r as

to

how

the

yw

ere

chos

en

Thr

ee p

artic

ipan

ts in

the

rela

xatio

n gr

oup

rece

ived

furt

her

psyc

holo

gica

l tre

atm

ent

durin

g th

e 33

-mon

th fo

llow

-up

perio

d

1. L

GE

2. P

rogr

essiv

e m

uscl

ere

laxa

tion

(pla

cebo

) (PM

R)

52 p

rese

nted

for

initi

alas

sess

men

t an

d th

e fir

st

45 w

ere

rand

omly

ass

igne

d to

the

thre

e gr

oups

(15

in e

ach)

.42

of t

he o

rigin

al 4

5 ag

reed

to

part

icip

ate

in t

he fo

llow

-up

phas

e

Hea

ding

,20

0110

1A

s de

scrib

ed in

Fra

ser98

Met

hod

of r

ando

misa

tion:

not

repo

rted

; blin

ded

asse

ssm

ent

was

und

erta

ken;

no

pow

erca

lcul

atio

n re

port

ed; l

oss

tofo

llow

-up

repo

rted

, but

not

reas

ons

NR

1. P

rolo

nged

sin

gle

sess

ion

ofLG

E2.

WLC

58 r

espo

nded

to

adve

rts,

of

who

m 4

5 m

et in

clus

ion

crite

ria. F

ive

with

drew

bef

ore

trea

tmen

t, le

avin

g 40

allo

cate

dto

tre

atm

ent,

13 in

the

CAV

Egr

oup,

14

in t

he L

GE

grou

pan

d 13

in t

he W

LC g

roup

[Com

mer

cial

-in-c

onfid

ence

info

rmat

ion

has

been

rem

oved

.]A

R, a

pplie

d re

laxa

tion;

LG

E, li

ve g

rade

d ex

posu

re; M

A, M

anag

ing

Anx

iety

, PM

R, p

rogr

essiv

e m

uscl

e re

laxa

tion;

SRI

, ser

onto

nin

reup

take

inhi

bito

r.

Appendix 6

92 TA

BLE

22

Stud

y ch

arac

teris

tics:

non

-RCT

s

Stud

yD

escr

ipti

on o

f CC

BT

Stud

y qu

alit

yC

o-th

erap

y or

med

icat

ion

Com

para

tor

Sam

ple

size

Dep

ress

ion/

anxi

ety:

incl

uded

pac

kage

s

Cav

anag

h,un

publ

ished

spon

sor

subm

issio

n,20

0484

BtB

No

com

para

tor

grou

p; n

oal

loca

tion;

no

blin

ded

asse

ssm

ent;

loss

to

follo

w-u

p re

port

ed, b

ut n

otre

ason

s; n

o po

wer

cal

cula

tion

repo

rted

; no

men

tion

of p

rogn

ostic

fact

ors

and

no a

djus

tmen

t fo

rco

nfou

ndin

g va

riabl

es

NR

Non

e21

9

Mar

ks, 2

00389

Cop

efo

r de

pres

sion/

anxi

ety;

bala

nce

for

gene

ral

anxi

ety/

depr

essio

n (d

escr

ibed

in Y

ates

100 )

No

com

para

tor

grou

p; n

o m

entio

nof

how

pat

ient

s ch

osen

for

allo

catio

n to

Cop

e; n

o bl

inde

das

sess

men

t; lo

ss t

o fo

llow

-up

repo

rted

, but

not

rea

sons

; no

pow

er c

alcu

latio

n; n

o de

scrip

tion

ofpr

ogno

stic

fact

ors

and

noad

just

men

t fo

r co

nfou

ndin

g

Of t

he 1

39 p

atie

nts

(from

the

four

pro

gram

mes

) who

gav

eda

ta, 4

5% w

ere

havi

ng c

urre

nttr

eatm

ent

from

the

ir G

P or

men

tal h

ealth

pro

fess

iona

l and

abou

t ha

lf w

ere

onps

ycho

trop

hic

med

icat

ion

Non

eA

tot

al o

f 355

ref

erra

ls to

the

four

pro

gram

mes

, 266

wer

esc

reen

ed, 2

10 w

ere

suita

ble,

of

who

m 4

2 (2

0%) r

efus

edtr

eatm

ent;

108

(51%

) had

pos

t-tr

eatm

ent

data

ava

ilabl

e; 6

0(2

9%) d

ropp

ed o

ut o

r w

ere

lost

to fo

llow

-up;

pos

t-tr

eatm

ent

data

ava

ilabl

e fo

r 33

Bal

ance

patie

nts

and

39 C

ope

patie

nts

Osg

ood-

Hyn

es,

1998

91C

ope

Ope

n co

hort

stu

dy; n

o co

mpa

rato

r,no

men

tion

of h

ow p

atie

nts

chos

enfo

r C

ope;

des

crip

tion

of d

ropo

uts,

all m

easu

res

self-

rate

d; n

o po

wer

calc

ulat

ion;

no

desc

riptio

n of

prog

nost

ic fa

ctor

s an

d no

adju

stm

ent

for

conf

ound

ing

Eigh

t pa

tient

s (2

0%) w

ere

onan

tidep

ress

ant

med

icat

ion,

on

ast

able

dos

e

Non

e41

Whi

tfiel

d,un

publ

ished

spon

sor

subm

issio

n,20

0493

Ove

rcom

ing

Dep

ress

ion

No

com

para

tor

grou

p; n

o m

entio

nof

allo

catio

n to

Ove

rcom

ing

Dep

ress

ion;

no

blin

ded

asse

ssm

ent;

loss

to

follo

w-u

p re

port

ed, b

ut n

otre

ason

s; n

o po

wer

cal

cula

tion;

no

men

tion

of p

rogn

ostic

fact

ors,

but

som

e an

alys

is of

con

foun

ding

fact

ors

(com

plet

ers

and

non-

com

plet

ers)

Nin

e of

22

attt

endi

ng s

cree

ning

inte

rvie

w w

ere

on p

sych

iatr

icm

edic

atio

n (4

1%)

Non

e80

initi

ally

ref

erre

d, 2

2 of

who

mat

tend

ed t

he s

cree

ning

asse

ssm

ent

inte

rvie

w a

nd 2

0at

tend

ed a

t le

ast

one

sess

ion

cont

inue

d


93


TA

BLE

22

Stud

y ch

arac

teris

tics:

non

-RCT

s (c

ont’d

)

Stud

yD

escr

ipti

on o

f CC

BT

Stud

y qu

alit

yC

o-th

erap

y or

med

icat

ion

Com

para

tor

Sam

ple

size

Dep

ress

ion/

anxi

ety:

oth

ers

Yate

s,un

publ

ished

,19

9610

0

CD

-RO

M o

f a s

ingl

e se

ssio

nco

nsist

ing

of 1

5 op

tions

, nin

eof

whi

ch w

ere

‘kno

win

g’ o

r‘d

oing

’ opt

ions

rel

ated

to

hom

e ex

erci

ses

and

prac

tical

assig

nmen

ts r

elat

ed t

ofa

vour

ed c

opin

g st

rate

gies

;op

tion

to r

etur

n fo

r m

ore

sess

ions

Patie

nts

assig

ned

alte

rnat

ely

toei

ther

Bal

ance

or

WLC

; no

blin

ded

asse

ssm

ent;

loss

to

follo

w-u

pre

port

ed a

nd s

ome

reas

ons

give

n;no

pow

er c

alcu

latio

n; p

rogn

ostic

fact

ors

iden

tifie

d an

d co

mpa

red

betw

een

two

grou

ps; a

djus

tmen

tfo

r co

nfou

nder

s: m

edic

atio

n,ba

selin

e sc

ores

, gen

der

and

num

ber

of s

essio

ns

12 o

f 20

in t

he B

alan

ce g

roup

and

seve

n of

19

in t

he c

ontr

olgr

oup

wer

e re

ceiv

ing

med

icat

ion

for

anxi

ety/

depr

essio

n

WLC

Initi

ally

45

refe

rral

s, w

ith 2

2 in

the

Bala

nce

grou

p an

d 23

in t

heW

LC g

roup

Pho

bia/

pani

c: in

clud

ed s

tudi

es

Kenw

right

,20

0185

FFC

ompa

rison

with

a c

linic

coh

ort,

but

allo

catio

n di

d no

t ta

ke p

lace

; no

blin

ded

asse

ssm

ent;

loss

to

follo

w-

up r

epor

ted,

but

not

rea

sons

; no

pow

er c

alcu

latio

n; n

o m

entio

n of

prog

nost

ic fa

ctor

s an

d no

adju

stm

ent

for

conf

ound

ing

NR

Clin

icia

n (n

urse

ther

apist

)-gu

ided

sel

f-ex

posu

re t

hera

py

54 F

F pa

tient

s an

d 31

clin

icia

n-gu

ided

the

rapy

Kenw

right

,20

0486

FFC

ompa

rison

bet

wee

n tw

o ty

pes

ofFF

del

iver

y, w

ith p

atie

nts

chos

enfo

r th

e In

tern

et v

ersio

n on

the

bas

isof

the

ir in

abili

ty t

o co

me

to c

linic

;no

blin

ded

asse

ssm

ent;

loss

to

follo

w-u

p re

port

ed, b

ut n

otre

ason

s; n

o po

wer

cal

cula

tion;

no

men

tion

of p

rogn

ostic

fact

ors

and

no a

djus

tmen

t fo

r co

nfou

ndin

gfa

ctor

s

NR

Ten

patie

nts

usin

gIn

tern

et F

F at

hom

ew

ere

com

pare

d w

ith

17 p

atie

nts

usin

g FF

in a

clin

ic s

ettin

g

56 p

atie

nts

wer

e in

itial

ly fe

lt to

be s

uita

ble

for

FF, 1

3 re

fuse

d,

45 s

tart

ed t

reat

men

t w

ith F

Fan

d 37

% d

ropp

ed o

ut. R

esul

tsre

port

ed fo

r: t

en in

the

hom

eIn

tern

et F

F gr

oup

and

17 in

the

FF c

linic

gro

up

Appendix 6

94 TA

BLE

23

Ther

apy

deta

ils: R

CTs

Stud

yR

ecru

itm

ent

Num

ber

of s

essi

ons

Leng

th o

f ses

sion

sT

hera

pist

con

tact

Pro

fess

iona

l bac

kgro

und

of t

hera

pist

Dep

ress

ion/

anxi

ety:

incl

uded

pac

kage

s

Prou

dfoo

t,20

0487

Refe

rral

by

GP

or s

cree

ning

with

GH

Q

One

intr

oduc

tory

ses

sion

and

eigh

t th

erap

y se

ssio

nsIn

trod

ucto

ry s

essio

n 15

min

utes

,th

erap

y se

ssio

ns 5

0 m

inut

esM

axim

um o

f 80

min

utes

ove

rth

e ei

ght

sess

ions

(up

to

5 m

inut

es a

t be

ginn

ing

and

end

of e

ach

sess

ion)

Prac

tice

nurs

e

Dep

ress

ion/

anxi

ety:

oth

ers

Chr

isten

sen,

2004

95M

ailsh

ot q

uest

ionn

aire

to

rand

omse

lect

ion

of 2

7,00

0 pe

ople

on

the

elec

tora

l reg

ister

Blue

Page

s an

d M

oodG

ym b

oth

cons

isted

of f

ive

sect

ions

, one

per

wee

k, w

ith a

six

th o

verv

iew

and

revi

sion

sect

ion.

Con

trol

:te

leph

oned

wee

kly

by la

yin

terv

iew

ers

NR

for

all t

hree

gro

ups

No

ther

apist

con

tact

repo

rted

in a

ny g

roup

Lay

inte

rvie

wer

s

Pho

bia/

pani

c: in

clud

ed s

tudi

es

Mar

ks, 2

00488

Refe

rred

by

heal

th p

rofe

ssio

nals

to B

ehav

iour

al P

sych

othe

rapy

Uni

t, M

auds

ley

Hos

pita

l, or

answ

ered

not

ices

in G

P pr

actic

esor

pho

bia

self-

help

gro

ups

Six

sess

ions

and

tw

o fo

llow

-up

sess

ions

(1 m

onth

and

3 m

onth

sla

ter)

1 ho

urTo

tal m

ean

ther

apist

tim

e pe

rpa

tient

was

76

±43

min

utes

for

the

FF g

roup

Two

nurs

es a

nd o

neps

ychi

atris

t, w

ho w

ere

expe

rienc

ed b

ehav

iour

ther

apist

s

Schn

eide

r,20

0590

27 fr

om m

enta

l hea

lthpr

ofes

siona

l, tw

o fr

om G

P, 29

from

Inte

rnet

info

rmat

ion,

16

from

mag

azin

e ad

vert

isem

ents

and

20 d

id n

ot s

ay

Six

19 o

n an

SSR

I, six

on

anot

her

antid

epre

ssan

t, ni

ne o

n a

seda

tive,

six

on

a �

-blo

cker

and

two

on a

n an

tipsy

chot

ic

Scre

enin

g (4

0 m

inut

es) a

ndsix

sup

port

tel

epho

ne c

alls

(abo

ut 1

8 m

inut

es e

ach)

;to

tal o

f 115

±44

min

utes

per

patie

nt, e

xclu

ding

scre

enin

g

Two

psyc

hiat

rists

with

expe

rienc

e of

CBT

Cla

rke,

200

297St

udy

broc

hure

s w

ere

sent

to

6994

HM

O m

embe

rs w

ith a

diag

nosis

of d

epre

ssio

n an

d 69

96m

atch

ed s

ampl

e w

ith n

o di

agno

sisof

dep

ress

ion

Mea

n nu

mbe

r of

ses

sions

: 2.6

(ran

ge 1

–20)

Self-

pace

d; le

ngth

NR

No

ther

apist

con

tact

repo

rted

No

ther

apist

con

tact

repo

rted

cont

inue

d


95


TA

BLE

23

Ther

apy

deta

ils: R

CTs

(con

t’d)

Stud

yR

ecru

itm

ent

Num

ber

of s

essi

ons

Leng

th o

f ses

sion

sT

hera

pist

con

tact

Pro

fess

iona

l bac

kgro

und

of t

hera

pist

Pho

bia/

pani

c: o

ther

stu

dies

Car

lbrin

g,20

0192

New

spap

er a

nd h

ealth

mag

azin

ear

ticle

s an

d In

tern

et li

nk fr

om t

heho

me

page

of t

he S

wed

ish N

atio

nal

Ass

ocia

tion

for

peop

le w

ith P

D

Six

mod

ules

ove

r 7–

12w

eeks

, num

ber

of s

essio

nsun

clea

r

Part

icip

ants

giv

en 1

4 da

ysto

com

plet

e ea

ch m

odul

eN

o di

rect

con

tact

with

par

ticip

ant.

All

cont

act

via

Inte

rnet

/e-m

ail.

Mea

n tim

e of

90

min

utes

per

part

icip

ant

for

asse

ssm

ent,

adm

inist

ratio

n an

d re

spon

ding

to

e-m

ails

NR

Car

lbrin

g,20

0394

Wai

ting

list

from

ano

ther

stu

dyco

hort

orig

inal

ly r

ecru

ited

byne

wsp

aper

and

hea

lth m

agaz

ine

artic

les

and

Inte

rnet

link

from

the

hom

e pa

ge o

f the

Sw

edish

Nat

iona

lA

ssoc

iatio

n fo

r pe

ople

with

PD

Six

mod

ules

; num

ber

ofse

ssio

ns N

RN

RN

o di

rect

con

tact

with

par

ticip

ant.

All

cont

act

via

Inte

rnet

/e-m

ail.

Mea

n to

tal t

ime

of 3

0 m

inut

essp

ent

by t

he t

hera

pist

on

each

part

icip

ant

usin

g st

anda

rdise

d e-

mai

l mes

sage

s

NR

Car

lbrin

g,20

0496

Wai

ting

list

from

ano

ther

stu

dyco

hort

orig

inal

ly r

ecru

ited

byne

wsp

aper

and

hea

lth m

agaz

ine

artic

les

and

Inte

rnet

link

from

the

hom

e pa

ge o

f the

Sw

edish

Nat

iona

lA

ssoc

iatio

n fo

r pe

ople

with

PD

Ten

mod

ules

; num

ber

ofse

ssio

ns N

RC

CBT

: ten

mod

ules

, len

gth

of s

essio

ns N

RTC

BT: t

en w

eekl

y in

divi

dual

sess

ions

, 45–

60 m

inut

esea

ch

CC

BT: N

R ap

art

from

initi

al S

CID

inte

rvie

w. A

ll co

ntac

t vi

a In

tern

et/e

-mai

lsTC

BT: 4

5–60

min

utes

per

ses

sion

CC

BT: N

RTC

BT: c

linic

al p

sych

olog

ists,

grad

uate

stu

dent

s in

clin

ical

psyc

holo

gy

Fras

er, 2

00198

New

spap

er a

nd n

otic

eboa

rdad

vert

isem

ents

1. T

hree

ses

sions

2. S

ix s

essio

ns

45 m

inut

es p

er s

essio

nT

hera

pist

car

ried

out

the

asse

ssm

ent

and

was

pre

sent

for

the

first

5 m

inut

es o

f the

tre

atm

ent

Post

grad

uate

stu

dent

incl

inic

al p

sych

olog

y

Gilr

oy, 2

000,

107

Gilr

oy, 2

00399

New

spap

er a

nd n

otic

eboa

rdad

vert

isem

ents

Thr

ee a

t 2-

wee

k in

terv

als

45 m

inut

esT

hera

pist

car

ried

out

the

thre

eas

sess

men

ts a

nd w

as p

rese

nt fo

rth

e fir

st 5

min

utes

of t

he fi

rst

sess

ion

Mas

ters

stu

dent

inps

ycho

logy

Hea

ding

,20

0110

1N

ewsp

aper

and

not

iceb

oard

adve

rtise

men

tsO

ne3

hour

s T

hera

pist

car

ried

out

the

asse

ssm

ent

and

was

pre

sent

for

the

first

5 m

inut

es o

f the

ses

sion

and

rese

t th

e pr

ogra

mm

e ev

ery

45m

inut

es

Hon

ours

stu

dent

inps

ycho

logy

[Com

mer

cial

-in-c

onfid

ence

info

rmat

ion

has

been

rem

oved

.]H

MO

, hea

lth m

aint

enan

ce o

rgan

isatio

n; S

CID

, Str

uctu

red

Clin

ical

Inte

rvie

w fo

r D

SM-IV

.

Appendix 6

96 TA

BLE

24

Ther

apy

deta

ils: n

on-R

CTs

Stud

yR

ecru

itm

ent

Num

ber

of s

essi

ons

Leng

th o

f ses

sion

sT

hera

pist

con

tact

Pro

fess

iona

l bac

kgro

und

of t

hera

pist

Dep

ress

ion/

anxi

ety:

incl

uded

pac

kage

s

Cav

anag

h,un

publ

ished

spon

sor

subm

issio

n,20

0484

Iden

tific

atio

n by

hea

lthca

repr

ofes

siona

l O

ne in

trod

ucto

ry s

essio

n an

dei

ght

ther

apy

sess

ions

Intr

oduc

tory

ses

sion

15 m

inut

es,

ther

apy

sess

ions

50

min

utes

5 m

inut

es a

t fir

st c

ompu

ter

sess

ion,

oth

er t

hera

pist

tim

eN

R

Loca

l ser

vice

rec

eptio

nist

or s

ecre

tary

Dep

ress

ion/

anxi

ety:

oth

ers

Yate

s,un

publ

ished

,19

9610

0

GP

refe

rral

One

, with

opt

ion

for

mor

e1

hour

plu

s 10

–30-

min

ute

debr

iefin

gA

few

min

utes

at

the

begi

nnin

g of

the

ses

sion

and

10–3

0 m

inut

es a

fterw

ards

,qu

erie

s an

swer

ed t

hrou

ghou

tth

e se

ssio

n

Psyc

holo

gist

Mar

ks, 2

00389

Self-

refe

rral

; adv

ertis

ed in

loca

lG

P su

rger

ies,

com

mun

ity m

enta

lhe

alth

cen

tres

, psy

chia

tric

outp

atie

nt c

linic

s, lo

cal p

aper

s,Ye

llow

Pag

es, v

olun

tary

orga

nisa

tions

and

NH

S D

irect

Cop

e: 1

22 ±

83 m

inut

es o

nte

leph

one

calls

, mea

n 11

±8

(ran

ge 0

–34)

cal

ls

NR

Cop

e: 4

6 ±

46 m

inut

es (f

ace

to fa

ce o

r liv

e su

ppor

t by

tele

phon

e)

Nur

se t

hera

pist

s

Osg

ood-

Hyn

es,

1998

91Re

ferr

als

from

men

tal h

ealth

and

prim

ary

care

pro

fess

iona

ls an

dne

wsp

aper

adv

ertis

emen

ts

Initi

al c

linic

visi

t to

vie

wvi

deot

ape,

mak

e fir

st t

wo

calls

and

rece

ive

expl

anat

ion

of C

ope

mat

eria

ls. 1

1 to

ll-fr

ee c

alls;

12

-wee

k fin

al c

linic

visi

t

Cal

ls af

ter

initi

al c

linic

visi

t la

sted

8–23

min

utes

. Len

gth

of t

wo

clin

ic v

isits

NR

Clin

icia

n as

sess

men

t at

initi

alvi

sitN

R

Whi

tfiel

d,un

publ

ished

spon

sor

subm

issio

n,20

0493

Con

secu

tive

refe

rral

s to

the

clin

ical

psy

chol

ogy

serv

ice

Six

45–6

0 m

inut

esSc

reen

ing

inte

rvie

w 2

0–30

min

utes

and

47.

4 m

inut

esto

tal f

or t

he s

ix s

essio

ns

Scre

enin

g by

clin

ical

psyc

holo

gist

, sel

f-he

lpsu

ppor

t nu

rse

at s

essio

ns

cont

inue

d


97


TA

BLE

24

Ther

apy

deta

ils: n

on-R

CTs

(con

t’d)

Stud

yR

ecru

itm

ent

Num

ber

of s

essi

ons

Leng

th o

f ses

sion

sT

hera

pist

con

tact

Pro

fess

iona

l bac

kgro

und

of t

hera

pist

Pho

bia/

pani

c: in

clud

ed s

tudi

es

Kenw

right

,20

0185

Adv

ertis

emen

ts in

GP

surg

erie

san

d se

lf-he

lp g

roup

s fo

r FF

patie

nts;

clin

icia

n re

ferr

als

cam

efr

om G

Ps a

nd p

sych

iatr

ists

Mea

n nu

mbe

r of

ses

sions

was

4,

rang

e no

t re

port

edM

ean

tota

l 202

min

utes

(1

39 m

inut

es o

n co

mpu

ter

and

63 m

inut

es w

ith n

urse

)

Mea

n to

tal p

er p

atie

nt o

f 63

min

utes

with

a n

urse

incl

udin

g sc

reen

ing

(20

min

utes

)

Clin

ical

nur

se s

peci

alist

s

Kenw

right

,20

0486

Self-

refe

rral

Unl

imite

d ac

cess

for

12-w

eek

perio

d fo

r In

tern

et g

roup

, sev

ense

ssio

ns fo

r cl

inic

gro

up

NR,

but

FF

was

use

d 16

±11

times

ove

r 66

±2.

5 da

ys b

yIn

tern

et F

F gr

oup.

Clin

ic F

Fus

ers

spen

t 23

7 ±

57 m

inut

es a

tth

e cl

inic

Inte

rnet

FF

user

s ha

d 11

3 ±

28.1

min

utes

of

ther

apist

tim

e. C

linic

FF

user

s ha

d 99

±11

.4 m

inut

esof

the

rapi

st t

ime

Nur

se t

hera

pist

Appendix 6

98 TA

BLE

25

Stud

y sit

e, fo

llow

-up

and

incl

usio

n/ex

clus

ion

crite

ria: R

CTs

Stud

ySt

udy

site

Leng

th o

f fol

low

-up

Num

bers

lost

to

Rea

sons

for

loss

to

Incl

usio

n cr

iter

iaEx

clus

ion

crit

eria

follo

w-u

pfo

llow

-up

Dep

ress

ion/

anxi

ety:

incl

uded

pac

kage

s

Prou

dfoo

t,20

0487

Nin

e G

P su

rger

ies

(sev

en in

pha

se 1

and

four

in p

hase

2) i

nLo

ndon

and

sou

th-e

ast

Engl

and

6 m

onth

s po

st-

trea

tmen

tBt

B: n

= 4

0 (n

= 5

4fr

om r

ando

misa

tion

allo

catio

n)TA

U: n

= 3

1 (n

= 4

3fr

om r

ando

misa

tion

allo

catio

n)

12 in

eac

h gr

oup

lost

to

hum

an e

rror

, oth

er r

easo

nsN

R ap

art

from

in p

hase

2,

seve

n of

12

drop

outs

of t

he55

pat

ient

s ra

ndom

ised

toBt

B qu

it ow

ing

todi

ssat

isfac

tion

with

trea

tmen

t. To

tal o

f 48

patie

nts

had

nopo

stra

ndom

isatio

n va

lues

Fam

iliar

ity w

ith c

ompu

ters

;G

P pa

tient

s ag

ed 1

8–75

year

s su

fferin

g fr

omde

pres

sion,

mix

edan

xiet

y/de

pres

sion,

anx

iety

diso

rder

(inc

ludi

ng p

hobi

asor

pan

ic),

not

curr

ently

rece

ivin

g an

y fo

rm o

fps

ycho

logi

cal t

reat

men

t or

coun

selli

ng

Act

ive

suic

idal

idea

s,cu

rren

t or

life

time

diag

nosis

of p

sych

osis

or o

rgan

icm

enta

l diso

rder

or

alco

hol

and

or d

rug

depe

nden

ce,

med

icat

ion

for

anxi

ety

and/

or d

epre

ssio

nco

ntin

uous

ly fo

r 6

mon

ths

or m

ore

befo

re e

ntry

;un

able

to

atte

nd e

ight

sess

ions

and

una

ble

to r

ead

or w

rite

Engl

ish

Dep

ress

ion/

anxi

ety:

oth

ers

Chr

isten

sen,

2004

95H

ome

Inte

rnet

trea

tmen

t, C

anbe

rra,

Aus

tral

ia

6 w

eeks

Blue

Page

s n

= 2

5,M

oodG

ym n

= 4

6,C

ontr

ol n

= 1

9

Moo

dGym

: no

reas

on g

iven

n=

12,

not

con

tact

able

n

= 1

0, t

oo b

usy

n=

7,

fam

ily r

easo

ns n

= 3

, did

not

like

it n

= 6

, tro

uble

with

Inte

rnet

n=

5, o

ther

n=

3

Blue

Page

s: t

oo b

usy

n=

5,

not

cont

acta

ble

n=

2,

trou

ble

with

Inte

rnet

n

= 1

, ill

n=

1, d

id n

ot li

keit

n=

1, i

ncor

rect

lyin

clud

ed n

= 1

, no

reas

ongi

ven

n=

4

Con

trol

: no

reas

on g

iven

n

= 1

4, lo

st in

tere

st n

= 1

,fa

mily

pro

blem

n=

1, t

oobu

sy n

= 1

, not

con

tact

able

n=

1, i

ll n

= 1

Scor

ed ≥

22 o

n th

e Ke

ssle

rps

ycho

logi

cal d

istre

ss s

cale

Rece

ivin

g cl

inic

al c

are

from

eith

er a

psy

chol

ogist

or

aps

ychi

atris

t

cont

inue

d


99


TA

BLE

25

Stud

y sit

e, fo

llow

-up

and

incl

usio

n/ex

clus

ion

crite

ria: R

CTs

(con

t’d)

Stud

ySt

udy

site

Leng

th o

f fol

low

-up

Num

bers

lost

to

Rea

sons

for

loss

to

Incl

usio

n cr

iter

iaEx

clus

ion

crit

eria

follo

w-u

pfo

llow

-up

Cla

rke,

200

297In

tern

et-b

ased

trea

tmen

t, Po

rtla

nd,

OR,

USA

32 w

eeks

79 d

id n

ot c

ompl

ete

atle

ast

one

follo

w-u

pas

sess

men

t.14

1 di

d no

t co

mpl

ete

4-w

eek

asse

ssm

ent;

104

did

not

com

plet

e 8-

wee

k as

sess

men

t, 10

3di

d no

t co

mpl

ete

16-w

eek

asse

ssm

ent;

122

did

not

com

plet

e32

-wee

k as

sess

men

t

NR

For

the

‘dep

ress

ed’ p

atie

ntgr

oup,

a r

ecor

ded

diag

nosis

of d

epre

ssio

n w

ithre

cord

ed r

ecen

t tr

eatm

ent

appr

opria

te fo

r de

pres

sion

(med

icat

ion

and

psyc

hoth

erap

y).

For

the

‘non

-dep

ress

edgr

oup’

, no

diag

nosis

of

depr

essio

n or

rec

orde

dre

cent

tre

atm

ent

appr

opria

te fo

r de

pres

sion

NR

Pho

bia/

pani

c: in

clud

ed s

tudi

es

Mar

ks, 2

00488

Beha

viou

ral

Psyc

hoth

erap

y U

nit,

Mau

dsle

y H

ospi

tal,

Lond

on, U

K

3 m

onth

sA

t 1-

mon

th fo

llow

-up:

FF g

roup

18/

37(4

8.6%

), cl

inic

ian

grou

p12

/39

(30.

8%),

rela

xatio

n gr

oup

3/17

(17.

7%);

3-m

onth

follo

w-u

p da

ta N

R

Reas

ons

repo

rted

for

27 o

f30

dro

pout

s at

stu

dyco

mpl

etio

n: t

wo

patie

nts

had

mov

ed, f

our

had

job

com

mitm

ents

, fiv

e ha

ddi

fficu

lties

goi

ng t

o cl

inic

,on

e ha

d a

med

ical

cond

ition

, six

wer

e ot

her

reas

ons

and

nine

wer

eun

know

n

DSM

-IV c

riter

iaag

orap

hobi

a w

ithou

t PD

,PD

with

ago

raph

obia

, soc

ial

phob

ia o

r sim

ple

phob

ia,

not

on a

ben

zodi

azep

ine

ora

diaz

epam

-equ

ival

ent

dose

of >

5 m

g pe

r da

y; n

ot >

21un

its (m

en) o

r >

14 u

nits

(wom

en) o

f alc

ohol

aw

eek;

not

beg

un o

rch

ange

d do

se o

r ty

pe o

fan

tidep

ress

ant

med

icat

ion

with

in t

he p

ast

4 w

eeks

Act

ive

psyc

hotic

illn

ess,

suic

idal

dep

ress

ion

ordi

sabl

ing

card

iac

orre

spira

tory

dise

ase co

ntin

ued

Appendix 6

100 TA

BLE

25

Stud

y sit

e, fo

llow

-up

and

incl

usio

n/ex

clus

ion

crite

ria: R

CTs

(con

t’d)

Stud

ySt

udy

site

Leng

th o

f fol

low

-up

Num

bers

lost

to

Rea

sons

for

loss

to

Incl

usio

n cr

iter

iaEx

clus

ion

crit

eria

follo

w-u

pfo

llow

-up

Schn

eide

r,20

0590

UK

bas

ed, b

utpa

rtic

ipan

ts w

ere

asfo

llow

s: 2

2 Lo

ndon

, 65

rest

of E

ngla

nd, f

ive

Wal

es, o

ne U

SA, o

neC

anad

a

Com

pute

r us

e: h

ome

59, o

ffice

11,

libr

ary

5,In

tern

et c

afé

7,fa

mily

/frie

nds

7, c

linic

2 (n

ot s

elf-

help

clin

ic);

53 w

ere

at o

ne s

itean

d 15

wer

e at

mor

eth

an o

ne s

ite

14 w

eeks

(10

wee

ks fo

rtr

eatm

ent,

1-m

onth

follo

w-u

p pe

riod)

45 r

ando

mise

d to

FF,

two

drop

ped

out

befo

rebe

ginn

ing

trea

tmen

t, of

the

43 w

ho u

sed

FF, 3

3co

mpl

eted

and

31

com

plet

ed 1

-mon

thfo

llow

-up

23 r

ando

mise

d to

MA

,tw

o w

ithdr

ew b

efor

etr

eatm

ent,

15co

mpl

eted

and

13

com

plet

ed 1

-mon

thfo

llow

-up

The

rapy

too

tim

e-co

nsum

ing

n=

4, w

ork

com

mitm

ent

n=

3,

pref

erre

d fa

ce-t

o-fa

ceth

erap

y n

= 3

, com

pute

rcr

ashe

d n

= 2

, wor

seni

ngde

pres

sion

n=

2,

conc

erne

d ab

out

med

ical

reco

rd n

= 1

, im

prov

ed

n=

1, u

ncon

tact

able

n=

4

Pres

ence

of a

gora

phob

iaw

ith o

r w

ithou

t PD

, soc

ial

phob

ia o

r sp

ecifi

c ph

obia

,ra

ted

≥4

on t

he 0

–8 g

loba

lph

obia

, mai

n pr

oble

m a

ndm

ain

goal

, pho

bia

dura

tion

>1

year

Cur

rent

psy

chot

ic il

lnes

s,su

icid

e pl

ans,

sev

ere

depr

essio

n; d

isabl

ing

card

iac

or r

espi

rato

rydi

seas

e, b

enzo

diaz

epin

e or

diaz

epam

-equ

ival

ent

dose

of >

5m

g pe

r da

y, a

lcoh

olab

use,

cha

nge

inan

tidep

ress

ant

med

icat

ion,

faile

d pa

st e

xpos

ure

ther

apy

of fi

ve o

r m

ore

sess

ions

, rea

ding

diso

rder

Pho

bia/

pani

c: o

ther

stu

dies

Car

lbrin

g,20

0192

Inte

rnet

-bas

edtr

eatm

ent,

Swed

en

7–12

wee

ks d

epen

ding

on t

he in

divi

dual

Befo

re b

asel

ine

mea

sure

men

ts: t

en;

afte

r ra

ndom

isatio

n: fi

ve(fo

ur C

CBT

and

one

WLC

)

CC

BT: l

ack

of t

ime

n=

3;

anot

her

patie

nt d

ropp

edou

t w

hen

diag

nose

d w

ithca

ncer

. Con

trol

: dro

pout

gave

no

reas

on

DSM

-IV c

riter

ia fo

r PD

;du

ratio

n of

≥1

year

; 18

–60

year

s ol

d; M

AD

RS-

SR d

epre

ssio

n to

tal o

f <21

poin

ts a

nd <

4 po

ints

on

the

suic

ide

ques

tion;

PD

as

a pr

imar

y pr

oble

m; a

t le

ast

one

full-

blow

n pa

nic

atta

ckor

one

lim

ited

sym

ptom

atta

ck d

urin

g pr

etre

atm

ent

base

line;

con

siste

ncy

ofm

edic

atio

n fo

r PD

Oth

er p

sych

iatr

ic c

o-m

orbi

dity

in im

med

iate

need

of t

reat

men

t;co

ncur

rent

CBT

; the

rapy

for

<6

mon

ths;

pre

viou

she

alth

pro

fess

iona

l con

tact

as a

con

sequ

ence

of p

anic

atta

cks;

epi

leps

y, k

idne

ypr

oble

ms,

str

okes

, org

anic

brai

n sy

ndro

me,

emph

ysem

a, h

eart

diso

rder

or c

hron

ic h

igh

bloo

dpr

essu

re

cont

inue

d


101


TA

BLE

25

Stud

y sit

e, fo

llow

-up

and

incl

usio

n/ex

clus

ion

crite

ria: R

CTs

(con

t’d)

Stud

ySt

udy

site

Leng

th o

f fol

low

-up

Num

bers

lost

to

Rea

sons

for

loss

to

Incl

usio

n cr

iter

iaEx

clus

ion

crit

eria

follo

w-u

pfo

llow

-up

Car

lbrin

g,20

0394

Inte

rnet

-bas

edtr

eatm

ent,

Swed

en7-

mon

th p

erio

dFi

ve (t

hree

from

CC

BTgr

oup

and

two

from

AR

grou

p)

Lack

of t

ime

for

mos

tD

urat

ion

of P

D o

f ≥1

year

;18

–60

year

s ol

d; M

AD

RS-

SR <

21 a

nd <

4 on

the

suic

ide

ques

tion;

PD

as

apr

imar

y pr

oble

m; a

t le

ast

one

full-

blow

n pa

nic

atta

ckor

one

lim

ited

sym

ptom

atta

ck d

urin

g pr

etre

atm

ent

base

line;

con

siste

ncy

ofm

edic

atio

n fo

r PD

Oth

er p

sych

iatr

ic c

o-m

orbi

dity

in im

med

iate

need

of t

reat

men

t;co

ncur

rent

CBT

or

in p

ast

6 m

onth

s; p

revi

ous

heal

thpr

ofes

siona

l con

tact

as

aco

nseq

uenc

e of

pan

icat

tack

s; e

pile

psy,

kid

ney

prob

lem

s, s

trok

es, o

rgan

icbr

ain

synd

rom

e,em

phys

ema,

hea

rt d

isord

eror

chr

onic

hig

h bl

ood

pres

sure

Car

lbrin

g,20

0496

Inte

rnet

-bas

edtr

eatm

ent,

Swed

en1

year

Thr

ee fr

om t

he C

CBT

grou

p, t

hree

from

the

TCBT

gro

up

Lack

of t

ime

was

the

mai

nre

ason

giv

enD

urat

ion

of P

D ≥

1 ye

ar;

18–6

0 ye

ars

old;

MA

DRS

-SR

<21

and

<4

poin

ts o

nth

e su

icid

e qu

estio

nnai

re;

PD a

s a

prim

ary

prob

lem

;co

nsist

ency

of m

edic

atio

nfo

r PD

Oth

er p

sych

iatr

ic c

o-m

orbi

dity

in im

med

iate

need

of t

reat

men

t;co

ncur

rent

CBT

or

in p

ast

6 m

onth

s; p

revi

ous

heal

thpr

ofes

siona

l con

tact

as

aco

nseq

uenc

e of

pan

icat

tack

s; e

pile

psy,

kid

ney

prob

lem

s, s

trok

es, o

rgan

icbr

ain

synd

rom

e,em

phys

ema,

hea

rt d

isord

er

Fras

er, 2

00198

Uni

vers

ity s

ettin

g,A

ustr

alia

4

wee

ks a

fter

trea

tmen

tSe

ven

(four

in t

heth

ree-

sess

ion

grou

p an

dth

ree

in t

he s

ix-s

essio

ngr

oup)

. Not

e: d

ropo

uts

wer

e re

plac

ed b

y ne

wpa

rtic

ipan

ts

Wor

k co

mm

itmen

ts

n=

1, t

rave

l com

mitm

ents

n=

3, p

artic

ipan

t sa

id w

ascu

red

n=

1, p

rogr

amm

eno

t he

lpfu

l n=

1

Dia

gnos

is of

spe

cific

pho

bia

(spi

der)

by

CID

I and

una

ble

to p

erfo

rm s

tep

7 of

the

BAT;

16–

65 y

ears

old

No

conc

urre

nt n

on-a

nxie

tydi

sord

er; a

lcoh

ol o

r ill

icit

drug

abu

se p

robl

em; t

akin

gps

ycho

trop

ic m

edic

atio

n;un

dert

aken

an

expo

sure

-ba

sed

trea

tmen

t in

the

pas

t

cont

inue

d

Appendix 6

102 TA

BLE

25

Stud

y sit

e, fo

llow

-up

and

incl

usio

n/ex

clus

ion

crite

ria: R

CTs

(con

t’d)

Stud

ySt

udy

site

Leng

th o

f fol

low

-up

Num

bers

lost

to

Rea

sons

for

loss

to

Incl

usio

n cr

iter

iaEx

clus

ion

crit

eria

follo

w-u

pfo

llow

-up

Gilr

oy, 2

000,

107

Gilr

oy, 2

00399

Uni

vers

ity s

ettin

g,A

ustr

alia

33 m

onth

sFi

ve (f

our

from

PM

Rgr

oup,

one

from

LG

Egr

oup)

. Not

e: d

ropo

uts

wer

e re

plac

ed b

y ne

wpa

rtic

ipan

tsFr

om fo

llow

-up

phas

e:th

ree

mor

e

Tim

e co

nstr

aint

s n

= 4

,m

ovin

g in

ters

tate

n=

1,

had

unde

rgon

e pr

ior

rela

xatio

n tr

eatm

ent

n=

1,

unco

ntac

tabl

e n

= 2

Dia

gnos

is of

spe

cific

pho

bia

(spi

der)

by

the

CID

I – A

uto

and

unab

le t

o pe

rfor

m s

tep

7 of

the

BAT

; 16–

60 y

ears

old.

To

cont

rol f

or g

ende

rdi

ffere

nces

, fem

ale

part

icip

ants

onl

y w

ere

recr

uite

d; m

inim

umdu

ratio

n of

pho

bia

of 1

yea

r

Con

curr

ent

non-

anxi

ety

diso

rder

; sim

ilar

trea

tmen

tin

the

pas

t; hi

stor

y of

affe

ctiv

e di

sord

er o

rps

ycho

sis

Hea

ding

,20

0110

1U

nive

rsity

set

ting,

Aus

tral

ia4

wee

ksO

ne fr

om t

he L

GE

grou

pN

RD

iagn

osis

of s

peci

fic p

hobi

a(s

pide

r) b

y th

e C

IDI –

Aut

o2.

1 an

d un

able

to

perf

orm

step

7 o

f the

BAT

. 16–

65ye

ars

old

Con

curr

ent

non-

anxi

ety

diso

rder

; sim

ilar

trea

tmen

tin

the

pas

t; su

bsta

nce-

abus

e pr

oble

m; t

akin

gps

ycho

trop

ic m

edic

atio

n

[Com

mer

cial

-in-c

onfid

ence

info

rmat

ion

has

been

rem

oved

.]C

IDI,

Com

posit

e In

tern

atio

nal D

iagn

ostic

Inte

rvie

w.


103


TA

BLE

26

Stud

y sit

e, fo

llow

-up

and

incl

usio

n/ex

clus

ion

crite

ria: n

on-R

CTs

Stud

ySt

udy

site

Leng

th o

f N

umbe

rs lo

st t

o R

easo

ns fo

r lo

ss t

o In

clus

ion

crit

eria

Excl

usio

n cr

iter

iafo

llow

-up

follo

w-u

pfo

llow

-up

Dep

ress

ion/

anxi

ety:

incl

uded

pac

kage

s

Cav

anag

h,un

publ

ished

spon

sor

subm

issio

n,20

0484

Eigh

t ge

nera

l pra

ctic

es(fo

ur r

ural

, fou

r ur

ban)

,tw

o co

mm

unity

men

tal

team

s an

d on

e pr

imar

yca

re c

linic

al p

sych

olog

yse

rvic

e in

Don

cast

er,

Che

shire

, Old

ham

,W

anta

ge a

nd N

ewpo

rt, U

K

6 m

onth

s13

5 pa

tient

s (6

1.6%

)co

mpl

eted

all

eigh

tse

ssio

ns, 4

0 pa

tient

s (1

8%)

com

plet

ed 6

-mon

th fo

llow

-up

que

stio

nnai

re

NR

16–7

5 ye

ars

old,

suf

ferin

gfr

om d

epre

ssio

n,an

xiet

y/de

pres

sion

oran

xiet

y di

sord

er in

clud

ing

pani

c or

pho

bias

Cur

rent

ly r

ecei

ving

face

-to-

face

psy

chol

ogic

altr

eatm

ent

or c

ouns

ellin

g,su

icid

al id

eatio

n, c

urre

ntdi

agno

sis o

f psy

chos

is,or

gani

c m

enta

l diso

rder

or

in a

cute

pha

se o

fdr

ug/a

lcoh

ol d

epen

denc

e

Mar

ks, 2

00389

Free

sel

f-he

lp c

linic

with

inW

est

Lond

on M

enta

lH

ealth

Tru

st a

nd C

harin

gC

ross

Cam

pus

of Im

peria

lC

olle

ge, U

K

Cop

e:

65 ±

59 d

ays

Cop

e n

= 1

6 (o

nead

ditio

nal p

atie

nt r

efus

edC

ope)

39 o

f the

tot

al 1

02 r

efus

ers

and

drop

outs

gav

e re

ason

sfo

r re

fusin

g or

not

com

plet

ing:

har

d to

att

end

clin

ic n

= 1

3, t

hera

pyun

help

ful n

= 1

0, w

antin

gfa

ce-t

o-fa

ce h

elp

n=

8,

low

mot

ivat

ion

n=

8,

offe

red

help

else

whe

re

n=

2, p

robl

em im

prov

ed

n=

2

Pres

ence

of a

n an

xiet

y or

depr

essiv

e di

sord

er,

mot

ivat

ion

to u

se s

elf-

help

Subs

tanc

e m

isuse

,ps

ycho

sis, a

ctiv

e su

icid

alpl

ans

Osg

ood-

Hyn

es,

1998

91Bo

ston

, MA

, USA

(n=

12)

,M

adiso

n W

I, U

SA (n

= 1

5),

Lond

on, U

K (n

= 1

4)

12 w

eeks

13Tw

o pa

tient

s di

d no

t us

eC

ope

afte

r th

e en

rolm

ent

visit

, 11

used

Cop

e bu

tst

oppe

d us

ing

it an

d di

d no

tat

tend

the

12-

wee

k of

fice

visit

Mild

to

mod

erat

ede

pres

sion

defin

ed b

yH

AM

-D, s

core

s of

12–

20w

ere

incl

uded

; 21–

75 y

ears

old

Cur

rent

or

lifet

ime

psyc

hotic

diso

rder

,pe

rson

ality

diso

rder

like

lyto

inte

rfer

e w

ith s

tudy

part

icip

atio

n, s

ubst

ance

abus

e di

sord

er (i

n th

e pa

st6

mon

ths)

, ser

ious

sui

cide

risk

or c

urre

ntly

unde

rgoi

ng C

BT

Whi

tfiel

d,un

publ

ished

spon

sor

subm

issio

n,20

0493

Clin

ical

Psy

chol

ogy

Serv

ice,

Gla

sgow

, UK

3 m

onth

s20

ent

ered

the

stu

dy, f

ive

(25%

) dro

pped

out

afte

rw

eek

1, o

ne d

ropp

ed o

utaf

ter

wee

k 3

NR

Refe

rral

lett

er n

oted

pres

ence

of d

epre

ssio

n/lo

wm

ood

as a

maj

or p

robl

em

Age

<16

or

>65

yea

rs,

curr

ent

activ

e su

icid

alin

tent

, psy

chos

is, u

nabl

e to

read

cont

inue

d

Appendix 6

104 TA

BLE

26

Stud

y sit

e, fo

llow

-up

and

incl

usio

n/ex

clus

ion

crite

ria: n

on-R

CTs

(con

t’d)

Stud

ySt

udy

site

Leng

th o

f N

umbe

rs lo

st t

o R

easo

ns fo

r lo

ss t

o In

clus

ion

crit

eria

Excl

usio

n cr

iter

iafo

llow

-up

follo

w-u

pfo

llow

-up

Dep

ress

ion/

anxi

ety:

oth

ers

Yate

s,un

publ

ished

,19

9610

0

GP

prac

tices

and

res

earc

hof

fice,

New

cast

le a

ndG

ates

head

, UK

1 m

onth

Two

out

of 2

2 in

Bal

ance

grou

p an

d th

ree

of 2

3 in

cont

rol g

roup

Bala

nce

grou

p: o

ne c

ould

not

be t

race

d af

ter

trea

tmen

t an

d on

e ch

ange

dhi

s m

ind

abou

t us

ing

the

com

pute

rC

ontr

ol g

roup

: tw

o ill

ness

,on

e co

uld

not

be t

race

d

GP’

s cl

inic

al ju

dgem

ent

Hist

ory

of m

ajor

psy

chia

tric

illne

ss o

r an

xiet

y fo

llow

ing

a m

ajor

life

tra

uma

Pho

bia/

pani

c: in

clud

ed s

tudi

es

Kenw

right

,20

0185

Self-

care

cen

tre

loca

ted

with

in a

n ou

tpat

ient

uni

t in

Lond

on, U

K

10 w

eeks

22 d

ropp

ed o

ut (4

1%)

NR

Patie

nts

with

pro

blem

ssu

itabl

e fo

r co

mpu

ter-

guid

ed c

are

Serio

us m

enta

l illn

ess,

seve

re d

epre

ssio

n, d

rug

oral

coho

l misu

se

Kenw

right

,20

0486

Hom

e us

e an

d se

lf-he

lpcl

inic

in w

est

Lond

on, U

K16

wee

ks (1

mon

th a

fter

end

of t

reat

men

t)

Dat

a on

ly r

epor

ted

for

ten

FF In

tern

et g

roup

and

17

FF c

linic

gro

up. 1

6 (3

7%)

of o

rigin

al s

ampl

e dr

oppe

dou

t be

fore

allo

catio

n to

two

grou

ps

NR

Pres

ence

of p

hobi

a or

PD

,m

otiv

atio

n to

try

sel

f-he

lpSu

bsta

nce

misu

se,

psyc

hosis

or

activ

e su

icid

alpl

ans


105


TA

BLE

27

Patie

nt c

hara

cter

istic

s: R

CTs

Stud

yM

etho

ds fo

r A

ge, m

ean

±SD

G

ende

r Et

hnic

ity

Educ

atio

n/Pa

tien

t hi

stor

yB

asel

ine

diag

nosi

s of

(y

ears

)(M

ale/

fem

ale)

soci

o-ec

onom

ic

com

para

bilit

ydi

sord

erba

ckgr

ound

Dep

ress

ion/

anxi

ety:

incl

uded

pac

kage

s

Prou

dfoo

t,20

0487

GH

Q s

core

of ≥

4an

d ≥

12 o

n th

eco

mpu

teris

edve

rsio

n of

PRO

QSY

BtB

43.6

±14

.3;

TAU

43.

4 ±

13.7

BtB

40/1

06;

TAU

32/

96Bt

B 90

% w

hite

;TA

U 8

7% w

hite

BtB:

63%

had

ove

r 12

yea

rs o

f edu

catio

nan

d 66

% w

ere

empl

oyed

TAU

: 63%

had

ove

r 12

yea

rs o

f edu

catio

nan

d 58

% w

ere

empl

oyed

BtB

15%

had

sev

ere

depr

essiv

e ep

isode

, 6%

pho

bias

, 6%

PD

,49

% m

ixed

anxi

ety/

depr

essio

n an

d24

% m

id/m

oder

ate

depr

essiv

e ep

isode

TAU

: 9%

sev

ere

depr

essiv

e ep

isode

,13

% p

hobi

as, 5

% P

D,

55%

mix

edan

xiet

y/de

pres

sion

and

19%

mild

/mod

erat

ede

pres

sive

episo

de

NR

Dep

ress

ion/

anxi

ety:

oth

ers

Chr

isten

sen,

2004

95Ke

ssle

r ps

ycho

logi

cal

dist

ress

sca

le36

.43

±9.

415

0/37

5N

RM

arrie

d or

coh

abiti

ng:

Blue

Pag

es 6

1%;

Moo

dGYM

54%

;co

ntro

l 56%

Year

s sp

ent

in e

duca

tion

(mea

n ±

SD):

Blue

Page

s 15

±2.

4;M

oodG

ym 1

4.6

±2.

4;co

ntro

l 14.

4 ±

2.3

Mor

e th

an 9

0%re

port

ed b

eing

mar

kedl

y de

pres

sed

befo

re t

he s

tudy

, with

64%

rep

ortin

g th

at t

hey

had

soug

ht p

rofe

ssio

nal

help

Repo

rted

; the

grou

ps d

id n

otdi

ffer

Cla

rke,

200

297N

o in

depe

nden

tco

nfirm

atio

n of

diag

nosis

with

stru

ctur

ed d

iagn

ostic

inte

rvie

w

For

both

dep

ress

edan

d no

t de

pres

sed

grou

ps: C

CBT

43

.3 ±

12.2

; con

trol

44.4

±12

.4

For

both

dep

ress

edan

d no

t de

pres

sed

grou

ps %

fem

ale:

CC

BT 7

3.6%

;co

ntro

l 77.

4%

Ethn

ic m

inor

ity:

CC

BT 5

.8%

; co

ntro

l 5.8

%

CC

BT g

roup

: 60.

3%m

arrie

d, 4

5.4%

col

lege

grad

uate

Con

trol

gro

up: 6

4.0%

mar

ried,

39.

4% c

olle

gegr

adua

te

NR

The

CC

BT a

ndco

ntro

l gro

up d

idno

t di

ffer

in t

erm

sof

gen

der,

age

orba

selin

e C

ESD

Psc

ore

cont

inue

d

Appendix 6

106 TA

BLE

27

Patie

nt c

hara

cter

istic

s: R

CTs

(con

t’d)

Stud

yM

etho

ds fo

r A

ge, m

ean

±SD

G

ende

r Et

hnic

ity

Educ

atio

n/Pa

tien

t hi

stor

yB

asel

ine

diag

nosi

s of

(y

ears

)(M

ale/

fem

ale)

soci

o-ec

onom

ic

com

para

bilit

ydi

sord

erba

ckgr

ound

Pho

bia/

pani

c: in

clud

ed s

tudi

es

Mar

ks, 2

00488

DSM

-IV c

riter

ia;

ratin

g of

≥4

on t

hegl

obal

pho

bia

scal

e of

the

FQ

38 ±

1228

/62

NR

Leng

th o

f edu

catio

n(m

ean

±SD

)11

±2

year

s

Illne

ss d

urat

ion

(mea

n ±

SD)

17 ±

12 y

ears

Yes,

apa

rt fr

omm

ore

FF p

atie

nts

than

clin

icia

npa

tient

s w

ere

sent

by G

P ra

ther

tha

nse

lf-re

ferr

ed (n

s)

Pho

bia/

pani

c: o

ther

stu

dies

Car

lbrin

g,20

0192

CID

I-sf;

PD s

ectio

nof

the

AD

IS fo

rD

SM-IV

34 ±

7.5

(ran

ge21

–51)

12/2

9N

RN

R34

% o

f the

sam

ple

had

not

rece

ived

any

tre

atm

ent

befo

re t

he s

tudy

The

tw

o gr

oups

did

not

diffe

rsig

nific

antly

on

any

of t

hepr

etre

atm

ent

mea

sure

s

Car

lbrin

g,20

0394

DSM

-IV (S

CID

)cr

iteria

for

PD37

.9 ±

8.6

7/15

NR

NR

Tota

l gro

up: y

ears

with

PD

(mea

n ±

SD) 1

0.4

±5.

2T

he t

wo

grou

psdi

d no

t di

ffer

signi

fican

tly o

n an

yof

the

pret

reat

men

tm

easu

res

Schn

eide

r,20

0590

Pret

reat

men

tas

sess

men

tqu

estio

nnai

re; I

CD

-10

che

cklis

t

39 ±

1118

/50

NR

Tota

l sam

ple

35m

arrie

d/co

habi

ting,

33

sin

gle,

sep

arat

ed,

wid

owed

or

divo

rced

;m

ean

year

s of

edu

catio

n12

±2

Prob

lem

dur

atio

n (m

ean

±SD

) 14

±13

yea

rsD

iagn

osis:

ago

raph

obia

with

pani

c: 2

FF,

0 M

A;

agor

apho

bia

with

out

pani

c:16

FF,

8 M

A; s

ocia

l pho

bia:

14 F

F, 3

MA

; sec

onda

rydi

agno

ses

incl

uded

the

abo

vean

d sp

ecifi

c ph

obia

,de

pres

sive

diso

rder

,ad

just

men

t di

sord

er,

subs

tanc

e ab

use

and

OC

D

The

tw

o gr

oups

did

not

diffe

rsig

nific

antly

on

any

dem

ogra

phic

or

clin

ical

feat

ure

cont

inue

d


107


TA

BLE

27

Patie

nt c

hara

cter

istic

s: R

CTs

(con

t’d)

Stud

yM

etho

ds fo

r A

ge, m

ean

±SD

G

ende

r Et

hnic

ity

Educ

atio

n/Pa

tien

t hi

stor

yB

asel

ine

diag

nosi

s of

(y

ears

)(M

ale/

fem

ale)

soci

o-ec

onom

ic

com

para

bilit

ydi

sord

erba

ckgr

ound

Car

lbrin

g,20

0496

CID

I 2.1

: PD

sect

ions

, AD

IS fo

rD

SM-IV

and

SC

ID

35 ±

7.7

14/ 3

5N

RN

RTo

tal g

roup

: yea

rs w

ith P

D(m

ean

±SD

) 9.0

±9.

3T

he t

wo

grou

psdi

d no

t di

ffer

signi

fican

tly o

n an

yof

the

pret

reat

men

tm

easu

res

Fras

er, 2

00198

CID

I, BA

T32

.6 ±

10.6

(ran

ge17

–54)

Initi

ally

28

fem

ale

and

two

mal

epa

rtic

ipan

ts, b

utaf

ter

drop

outs

all

fem

ale

All

whi

te15

par

ticip

ants

wer

eem

ploy

ed, 1

2un

empl

oyed

and

thr

eest

uden

ts

NR

No

signi

fican

tdi

ffere

nce

betw

een

grou

ps in

rel

atio

nto

age

, est

imat

edin

telle

ctua

l lev

el o

ran

y ou

tcom

em

easu

res

Gilr

oy, 2

000,

107

Gilr

oy, 2

00399

CID

I, BA

T; N

atio

nal

Adu

lt Re

adin

g Te

st(N

ART

)

33.1

1 ±

10.8

5(r

ange

17–

59)

Fem

ales

onl

yA

ll w

hite

30 p

artic

ipan

ts w

ere

empl

oyed

, 11

unem

ploy

ed a

nd fo

urst

uden

ts

NR

No

signi

fican

tdi

ffere

nce

betw

een

grou

ps a

part

from

PT t

otal

sco

res,

whi

ch s

how

ed a

signi

fican

tdi

ffere

nce

betw

een

the

LGE

and

PMR

grou

ps

Hea

ding

,20

0110

1C

IDI-A

34.9

±11

.0 (r

ange

18–6

1)2/

38A

ll w

hite

26

wer

e em

ploy

ed, s

even

unem

ploy

ed a

nd s

even

stud

ents

NR

No

signi

fican

tdi

ffere

nce

betw

een

the

grou

ps,

pret

reat

men

t, in

age,

est

imat

edin

telli

genc

e or

any

of t

he o

utco

me

mea

sure

s

[Com

mer

cial

-in-c

onfid

ence

info

rmat

ion

has

been

rem

oved

.]A

DIS

, Anx

iety

Diso

rder

s In

terv

iew

Sch

edul

e; C

IDI-A

, Com

posit

e In

tern

atio

nal D

iagn

ostic

Inte

rvie

w –

Aut

o 2.

1; C

ICI-S

F, C

ompo

site

Inte

rnat

iona

l Dia

gnos

tic In

terv

iew

– s

hort

ened

form

; PRO

QSY

, Pro

gram

mab

le Q

uest

ionn

aire

Sys

tem

.

Appendix 6

108 TA

BLE

28

Patie

nt c

hara

cter

istic

s: n

on-R

CTs

Stud

yM

etho

ds fo

r A

ge

Gen

der

Ethn

icit

yEd

ucat

ion/

Pati

ent

hist

ory

Bas

elin

e di

agno

sis

of

(Mal

e/fe

mal

e)so

cio-

econ

omic

co

mpa

rabi

lity

diso

rder

back

grou

nd

Cav

anag

h,un

publ

ished

spon

sor

subm

issio

n,20

0484

GH

Q-1

2 sc

ore

of≥

443

.5 ±

11.6

88/1

31N

RN

RPr

oble

m d

urat

ion:

(mea

n ±

SD) 6

.66

±9.

1 ye

ars

(ran

ge1

mon

th t

o 47

yea

rs);

info

rmat

ion

avai

labl

e fo

r 19

6of

the

219

pat

ient

s: 3

2(1

6%) r

epor

ted

depr

essio

n,31

(16%

) rep

orte

d an

xiet

y,12

8 (6

5%) r

epor

ted

mix

edan

xiet

y/de

pres

sion,

four

(2%

) rep

orte

d an

othe

rsp

ecifi

c pr

oble

m

NA

Mar

ks, 2

00389

Scre

enin

gqu

estio

nnai

re;

ICD

-10

For

tota

l sam

ple:

mea

n ag

e of

com

plet

ers

(n=

108

) 39

±12

;m

ean

age

of n

on-

com

plet

ers

(n=

60)

36 ±

11

For

tota

l sam

ple:

com

plet

ers

51/5

7;no

n-co

mpl

eter

s32

/29

NR

For

tota

l sam

ple:

Com

plet

ers:

hig

hpr

ofes

siona

l n=

7,

mid

dle

prof

essio

nal

n=

30,

low

pro

fess

iona

ln

= 2

0, m

anua

l wor

ker

n=

9, u

nem

ploy

ed/

stud

ent

n=

38,

unk

now

nn

= 4

Non

-com

plet

ers:

hig

hpr

ofes

siona

l n=

1,

mid

dle

prof

essio

nal

n=

15,

low

pro

fess

iona

ln

= 1

6, m

anua

l wor

ker

n=

4, u

nem

ploy

ed/

stud

ent

n=

22,

unk

now

nn

= 2

Prob

lem

dur

atio

n fo

r to

tal

sam

ple

(mea

n ±

SD)

8 ±

10 y

ears

(com

plet

ers:

7

±8

year

s, r

efus

als

11 ±

11 y

ears

, non

-co

mpl

eter

s 9

±10

yea

rs)

NA

cont

inue

d


109


TA

BLE

28

Patie

nt c

hara

cter

istic

s: n

on-R

CTs

(con

t’d)

Stud

yM

etho

ds fo

r A

ge

Gen

der

Ethn

icit

yEd

ucat

ion/

Pati

ent

hist

ory

Bas

elin

e di

agno

sis

of

(Mal

e/fe

mal

e)so

cio-

econ

omic

co

mpa

rabi

lity

diso

rder

back

grou

nd

Osg

ood-

Hyn

es,

1998

91C

linic

ian-

adm

inist

ered

stru

ctur

ed c

linic

alin

terv

iew

for

DSM

-IV

crit

eria

for

maj

orde

pres

sion

and/

ordy

sthy

mia

/; H

AM

-Dsc

ore

42 ±

1312

/29

NR

18 (4

4%) w

ere

mar

ried

or c

ohab

iting

, 14

(34%

)ha

d ne

ver

been

mar

ried,

eigh

t (2

0%) w

ere

divo

rced

and

one

(2%

)w

as w

idow

ed

Maj

or d

epre

ssio

n, s

ingl

e or

recu

rren

t 25

(61%

),dy

sthy

mia

11

(27%

), do

uble

depr

essio

n (b

oth

maj

orde

pres

sion

and

dyst

hym

ia)

five

(12%

). M

ean

time

since

onse

t of

firs

t ep

isode

of

depr

essio

n 5

year

s (r

ange

<1–

22 y

ears

). M

ore

patie

nts

wer

e di

agno

sed

with

dyst

hym

ia in

Lon

don

than

inBo

ston

or

Mad

ison.

Lon

don

patie

nts

wer

e sig

nific

antly

youn

ger.

17 (4

2%) h

adpr

evio

usly

had

psy

chot

hera

pyfo

r de

pres

sion,

13

(32%

) sai

dde

pres

sion

coul

d be

due

to

deat

h of

som

eone

the

y kn

ew

NA

Whi

tfiel

d,un

publ

ished

spon

sor

subm

issio

n,20

0493

Scre

enin

gap

poin

tmen

t w

ithbr

ief r

isk a

sses

smen

t

38.1

±13

.07

13/9

NR

12 (5

7%) e

mpl

oyed

,se

ven

(33%

) stu

dent

s an

dth

ree

(14%

) une

mpl

oyed

NR

NA

Dep

ress

ion/

anxi

ety:

oth

ers

Yate

s,un

publ

ished

,19

9610

0

GP’

s cl

inic

alju

dgem

ent

Bala

nce

44.5

, WLC

42.5

, (SD

s N

R)Ba

lanc

e: 1

0/10

;co

ntro

l: 14

/6N

RBa

lanc

e: 2

5% in

full-

or

part

-tim

e em

ploy

men

t;six

sin

gle,

nin

e m

arrie

d,fo

ur d

ivor

ced/

sepa

rate

d,on

e w

idow

edW

LC: 2

5% in

full-

or

part

-tim

e em

ploy

men

t;se

ven

singl

e, s

ix m

arrie

d,six

div

orce

d/se

para

ted,

one

wid

owed

NR

No

signi

fican

tdi

ffere

nces

in a

nych

arac

teris

tics

mea

sure

d

cont

inue

d

Appendix 6

110 TA

BLE

28

Patie

nt c

hara

cter

istic

s: n

on-R

CTs

(con

t’d)

Stud

yM

etho

ds fo

r A

ge

Gen

der

Ethn

icit

yEd

ucat

ion/

Pati

ent

hist

ory

Bas

elin

e di

agno

sis

of

(Mal

e/fe

mal

e)so

cio-

econ

omic

co

mpa

rabi

lity

diso

rder

back

grou

nd

Pho

bia/

pani

c: in

clud

ed s

tudi

es

Kenw

right

,20

0185

NR

FF 3

8; c

linic

ian

40(S

Ds

NR)

FF 1

9/35

; clin

icia

n15

/16

NR

NR

FF: 1

4 ag

orap

hobi

a, s

ocia

lph

obia

n=

9, s

peci

ficph

obia

s n

= 8

, GA

D p

lus

pani

c n

= 1

, mea

n pr

oble

mdu

ratio

n: 2

2 ye

ars

Clin

icia

n: a

gora

phob

ia

n=

12,

soc

ial p

hobi

a n

= 1

1, s

peci

fic p

hobi

as

n=

8, m

ean

prob

lem

dura

tion

29 y

ears

FF g

roup

was

com

para

bly

seve

reon

six

mea

sure

s to

clin

icia

n gr

oup,

but

signi

fican

tly le

ssse

vere

on

FQag

orap

hobi

a an

dgl

obal

pho

bia,

mai

ngo

al a

nd W

SAso

cial

and

priv

ate

leisu

re

Kenw

right

,20

0486

Inte

rvie

w c

heck

list

ofIC

D-1

0 di

agno

stic

crite

ria

Inte

rnet

FF

37; c

linic

FF 3

6 (S

Ds

NR)

In

tern

et F

F gr

oup:

6/4;

clin

ic F

F 9/

8N

RIn

tern

et F

F gr

oup:

five

infu

ll-tim

e em

ploy

men

t;cl

inic

FF

grou

p: 1

3em

ploy

ed fu

ll tim

e

Inte

rnet

FF:

ago

raph

obia

with

pan

ic n

= 6

, soc

ial

phob

ia n

= 3

, ins

ect

phob

iaan

d cl

aust

roph

obia

n=

1;

five

had

co-m

orbi

d co

nditi

on(d

epre

ssio

n n

= 3

, GA

D

n=

2)

Clin

ic F

F: s

peci

fic p

hobi

a n

=7,

ago

raph

obia

with

pan

ic n

= 5

, soc

ial p

hobi

a n

= 4

,pa

nic

with

GA

D n

= 1

, sev

enha

d a

co-m

orbi

d co

nditi

on(d

epre

ssio

n n

= 2

, soc

ial

phob

ia n

= 2

, GA

D n

= 2

,O

CD

n=

1)

NR

NA

, not

app

licab

le.


111


TA

BLE

29

Out

com

es a

nd a

naly

sis in

form

atio

n: R

CTs

Stud

yO

utco

mes

In

stru

men

ts

Mea

sure

men

t pe

riod

sIT

T a

naly

sis

Dep

ress

ion/

anxi

ety:

incl

uded

pac

kage

s

Prou

dfoo

t,20

0487

Dep

ress

ion,

anx

iety

, wor

k an

d so

cial

adju

stm

ent,

and

satis

fact

ion

with

tre

atm

ent

BDI,

BAI,

WSA

, ASQ

(inc

ludi

ng a

com

posit

ein

dex

for

nega

tive

situa

tions

and

aco

mpo

site

scor

e fo

r po

sitiv

e sit

uatio

ns)

Pre-

and

pos

t-tr

eatm

ent

and

1-, 3

- an

d 6-

mon

th fo

llow

-up

Yes,

but

pre

trea

tmen

t va

lues

onl

yre

port

ed fo

r 12

7/14

6 Bt

B pa

tient

s an

d11

4/12

8 TA

U p

atie

nts

Dep

ress

ion/

anxi

ety:

oth

ers

Chr

isten

sen,

2004

95Pr

efer

ence

for

trea

tmen

t, de

pres

sion

sym

ptom

cha

nge,

dep

ress

ion

liter

acy

CES

DP,

ATQ

, ad

hoc

ques

tionn

aire

s to

elic

itpa

rtic

ipan

ts’ p

refe

renc

e an

d m

edic

al,

psyc

holo

gica

l, lif

esty

le a

nd C

BT li

tera

cy

Pre-

and

pos

t-tr

eatm

ent

Yes

Pho

bia/

pani

c: in

clud

ed s

tudi

es

Mar

ks, 2

00488

Prim

ary

outc

ome

mea

sure

s: a

sses

sor

and

self-

ratin

gs o

f mai

n pr

oble

m a

nd g

oals,

glob

al p

hobi

a ite

m o

f FQ

; tim

e sp

ent

with

clin

icia

n; s

econ

dary

mea

sure

s: W

SA; p

atie

ntsa

tisfa

ctio

n, p

atie

nt-r

ated

mot

ivat

ion

to d

ose

lf-he

lp

Mai

n pr

oble

ms

and

goal

s, g

loba

l pho

bia

item

of F

Q, W

SAPr

e- a

nd p

ost-

trea

tmen

t an

d1-

and

3-m

onth

follo

w-u

p Ye

s, b

ut o

f the

93

patie

nts

rand

omise

don

ly 9

0 w

ere

incl

uded

in t

he a

naly

sis

Pho

bia/

pani

c: o

ther

stu

dies

Car

lbrin

g,20

0192

Anx

iety

leve

ls an

d pa

nic

atta

cks

BSQ

, AC

Q, M

I, BA

I, BD

I, Q

OLI

pan

ic d

iary

,TC

SPr

e- a

nd p

ost-

trea

tmen

t.Ye

s

Car

lbrin

g,20

0394

Anx

iety

leve

ls an

d pa

nic

atta

cks

BSQ

, AC

Q, M

I, BA

I, BD

I, Q

OLI

, TC

SPr

e- a

nd p

ost-

trea

tmen

tYe

s

Schn

eide

r,20

0590

Prim

ary

outc

ome

mea

sure

s: a

sses

sor

and

self-

ratin

gs o

f mai

n pr

oble

m a

nd g

oals,

glob

al p

hobi

a ite

m o

f FQ

and

glo

bal

impr

essio

n; s

econ

dary

mea

sure

s W

SA a

ndpa

tient

sat

isfac

tion

Mai

n pr

oble

m a

nd g

oals,

glo

bal p

hobi

a ite

mof

FQ

, glo

bal i

mpr

essio

n, W

SAPr

etre

atm

ent

(wee

k 0)

, pos

t-tr

eatm

ent

(wee

k 10

) and

1-

mon

th fo

llow

-up

(wee

k 14

)

Yes,

but

of 4

5 ra

ndom

ised

to F

F on

ly33

com

plet

ed, a

nd o

f 23

rand

omise

dto

MA

onl

y 15

com

plet

ed a

nd w

ere

incl

uded

in t

he a

naly

sis

Cla

rke,

200

297D

epre

ssio

nC

ESD

PBa

selin

e an

d 4-

, 8-,

16-

and

32-w

eek

follo

w-u

pYe

s

cont

inue

d

Appendix 6

112 TA

BLE

29

Out

com

es a

nd a

naly

sis in

form

atio

n: R

CTs

(con

t’d)

Stud

yO

utco

mes

In

stru

men

ts

Mea

sure

men

t pe

riod

sIT

T a

naly

sis

Car

lbrin

g,20

0496

Anx

iety

leve

ls an

d pa

nic

atta

cks

BSQ

, AC

Q, M

I, BA

I, BD

I, Q

OLI

, MA

DRS

-SR

, TC

SPr

e- a

nd p

ost-

trea

tmen

t an

d12

-mon

th fo

llow

-up

Yes,

pos

t-tr

eatm

ent

data

wer

eco

llect

ed fr

om a

ll dr

opou

ts. F

or t

hose

six p

artic

ipan

ts w

ho d

id n

ot r

etur

nth

eir

1-ye

ar fo

llow

-up

ques

tionn

aire

s,th

eir

post

-tre

atm

ent

scor

es w

ere

carr

ied

forw

ard

Fras

er, 2

00198

Impr

ovem

ent

in p

hobi

asBA

T, S

UD

S, S

PQ, F

Q, P

T, W

ARS

, HW

QPr

e- a

nd p

ost-

trea

tmen

t an

dfo

llow

-up

No

Gilr

oy, 2

000,

107

Gilr

oy, 2

00399

Impr

ovem

ent

in p

hobi

aBA

T, S

UD

S, S

Q, F

Q, P

T, W

ARS

; TH

and

TA

mea

sure

d by

an

anal

ogue

sca

le b

etw

een

1an

d 7.

Ad

hoc

mea

sure

dev

elop

ed o

nly

for

thes

e st

udie

s

Pre-

and

pos

t-tr

eatm

ent

and

3- a

nd 3

3-m

onth

follo

w-u

pN

o

Hea

ding

,20

0110

1Im

prov

emen

t in

pho

bia

BAT,

SU

DS,

SQ

, FQ

, PT,

WA

RS, T

CS,

TH

and

TAPr

e- a

nd p

ost-

trea

tmen

t an

dfo

llow

-up

No

[Com

mer

cial

-in-c

onfid

ence

info

rmat

ion

has

been

rem

oved

.]H

WQ

, Hom

ewor

k Q

uest

ionn

aire

; TA

, tre

atm

ent

acce

ptab

ility

; TC

S, T

reat

men

t C

redi

bilit

y Sc

ale;

TH

, tre

atm

ent

help

fuln

ess.


113


TA

BLE

30

Out

com

es a

nd a

naly

sis in

form

atio

n: n

on-R

CTs

Stud

yO

utco

mes

In

stru

men

ts

Mea

sure

men

t pe

riod

sIT

T a

naly

sis

Dep

ress

ion/

anxi

ety:

incl

uded

pac

kage

s

Cav

anag

h,un

publ

ished

spon

sor

subm

issio

n,20

0484

Impr

ovem

ent

in d

epre

ssio

n an

d an

xiet

yC

ORE

-OM

, WSA

and

wee

kly

singl

e-ite

mm

easu

res

of a

nxie

ty a

nd d

epre

ssio

nPr

e- a

nd p

ost-

trea

tmen

t an

d6-

mon

th fo

llow

-up

No

Dep

ress

ion/

anxi

ety:

oth

ers

Yate

s,un

publ

ished

1996

100

Dep

ress

ion

and

anxi

ety

impr

ovem

ent

HA

DS,

GH

Q-1

2, C

RIPr

e- a

nd p

ost-

trea

tmen

tN

o

Pho

bia/

pani

c: in

clud

ed s

tudi

es

Kenw

right

,20

0185

Clin

icia

n tim

e, r

educ

tion

in p

hobi

a an

d pa

nic

FQ, W

SA, m

ain

phob

ic t

rigge

r an

d m

ain

goal

Pre-

and

pos

t-tr

eatm

ent

Yes,

dro

pout

s w

ere

rega

rded

as

unim

prov

ed in

the

ana

lysis

Kenw

right

,20

0486

Phob

ia/p

anic

and

sat

isfac

tion

FQ, W

SAPr

e- a

nd p

ost-

trea

tmen

t an

d 1

mon

th fo

llow

-up

No

Mar

ks, 2

00389

Redu

ctio

n in

sym

ptom

sBD

I, H

RSD

, WSA

, BA

IPr

e- a

nd p

ost-

trea

tmen

tN

o

Osg

ood-

Hyn

es,

1998

91D

epre

ssio

n an

d W

SA s

core

sH

AM

-D, P

GI o

f im

prov

emen

t (c

ompu

ter

adm

inist

ered

), W

SA

Base

line,

4, 8

and

12

wee

ksfo

r co

mpu

ter-

adm

inist

ered

mea

sure

s. P

GI a

nd H

AM

-Dw

ere

also

giv

en a

t w

eeks

1an

d 2

Yes

Whi

tfiel

d,un

publ

ished

spon

sor

subm

issio

n,20

0493

Dep

ress

ion,

anx

iety

, hop

eles

snes

s, s

ocia

lad

apta

tion,

sat

isfac

tion

and

subj

ectiv

ekn

owle

dge

BDI-I

I, BA

I, BH

S, S

ASS

BDI-I

I bef

ore

first

five

ses

sions

and

afte

r six

th s

essio

n;su

bjec

tive

know

ledg

e at

wee

ks1

and

6, a

nd B

AI,

BHS

and

SASS

at

wee

ks 1

, 6 a

nd

3-m

onth

follo

w-u

p

Stat

ed t

o be

ITT,

but

last

dat

a po

int

carr

ied

forw

ard

for

drop

outs

(n=

6)

PGI,

patie

nts

glob

al im

pres

sion.

Appendix 6

114 TA

BLE

31

Resu

lts o

f rep

orte

d ou

tcom

es (

psyc

holo

gica

l sym

ptom

s an

d in

terp

erso

nal a

nd s

ocia

l fun

ctio

ning

: RCT

s

Stud

yR

esul

tsO

ther

out

com

e in

form

atio

n

Dep

ress

ion/

anxi

ety:

incl

uded

pac

kage

s

Prou

dfoo

t,20

0487

BD

I, B

AI,

WSA

, CoN

eg a

nd C

oPos

, pre

- an

d po

st-t

reat

men

t an

d fo

llow

-up

(mea

n ±

SD)

Pre

Post

3 m

onth

s5

mon

ths

8 m

onth

s

BDI

BtB

24.9

±10

.812

.1 ±

9.3

12.1

±10

.39.

6 ±

8.2

9.3

±8.

5n

127

9593

8394

TAU

24.7

±9.

218

.4 ±

10.9

16.4

±11

13.5

±10

.314

.9 ±

11.3

n11

410

085

8192

BAI

BtB

18.3

±10

.210

.9 ±

8.4

10.3

±8.

79.

6 ±

9.0

8.9

±8.

3n

123

9993

8491

TAU

19.4

±9.

314

.4 ±

1012

.4 ±

10.1

10.4

±7.

910

.9 ±

9n

107

9885

8091

WSA

BtB

18.4

±9.

211

.2 ±

7.6

10.5

±8.

59.

1 ±

7.7

7.9

±7.

8n

130

105

9995

103

TAU

19.1

±8.

314

.6 ±

8.5

14.0

±9.

511

.5 ±

8.5

11.8

±10

n11

210

386

8594

CoN

egBt

B87

.4 ±

13.7

73.8

±17

.673

.2 ±

1774

.9 ±

16.6

74.6

±17

.2n

118

9691

8693

TAU

86.0

±15

.985

.9 ±

1583

.5 ±

16.9

83.4

±15

.784

.6 ±

17.5

n10

796

8079

86

CoPo

sBt

B83

.8 ±

12.4

90.3

±15

.484

.5 ±

11.9

89.6

±16

84.6

±14

.9n

114

9793

8792

TAU

84.9

±14

.285

.7 ±

14.1

81.4

±12

.785

.0 ±

1580

.1 ±

16.1

n10

192

7882

89

Line

ar m

ixed

effe

cts

mod

els

wer

e us

ed t

ode

term

ine

the

rela

tions

hip

of r

espo

nse

toot

her

varia

bles

. Effi

cacy

was

una

ffect

ed b

yag

e, g

ende

r, co

ncom

itant

dru

g tr

eatm

ent

ordu

ratio

n of

pre

-exi

stin

g ill

ness

. Sev

erity

of

illne

ss h

ad a

n ef

fect

on

anxi

ety

and

posit

ive

attr

ibut

iona

l sty

le, s

o th

at o

nly

mor

e se

vere

lyill

pat

ient

s be

nefit

ed fr

om B

tB c

ompa

red

with

TAU

on

this

mea

sure

cont

inue

d


115


TA

BLE

31

Resu

lts o

f rep

orte

d ou

tcom

es (

psyc

holo

gica

l sym

ptom

s an

d in

terp

erso

nal a

nd s

ocia

l fun

ctio

ning

: RCT

s (c

ont’d

)

Stud

yR

esul

tsO

ther

out

com

e in

form

atio

n

Sum

mar

y m

easu

re r

esul

ts (

mea

ns fo

r av

aila

ble

post

rand

omis

atio

n va

lues

for

each

par

tici

pant

)

BtB

TAU

Out

com

e BD

I11

.6 ±

9.6

16.2

±10

.1n

112

109

t=

3.5

0, d

f = 2

19, p

= 0

.000

6, C

I 2.0

1 to

7.2

2

Out

com

e BA

I10

.6 ±

8.4

12.8

±9.

1n

115

110

t=

1.8

7, d

f = 2

23, p

= 0

.06,

CI –

0.12

to

4.47

Out

com

e W

SA10

.0 ±

7.8

13.4

±8.

6n

115

110

t=

3.1

0, d

f = 2

23, p

= 0

.002

, CI 1

.23

to 5

.55

Out

com

e Co

Neg

73.7

±15

.384

.1 ±

13.6

n10

610

6t

= 5

.2, d

f = 2

10, p

< 0

.001

, CI 6

.5 t

o 14

.36

Out

com

e Co

Pos

87.6

±13

.582

.8 ±

12.5

n10

810

6t

= –

2.7,

df =

212

, p<

0.0

08, C

I –8.

30 t

o –1

.28

Chr

isten

sen,

2004

95

Dep

ress

ion/

anxi

ety:

oth

ers

Impr

ovem

ent

in s

ympt

oms

and

liter

acy

afte

r 6

wee

ks; m

ean

±SD

sco

re, d

iffer

ence

(95

% C

I)

Blue

Pag

esM

oodG

ymCo

ntro

l

CES

DP

3.9

±9.

14.

2 ±

9.1

1.0

±8.

4AT

Q6.

4 ±

18.1

9.3

±16

.93.

1 ±

15.8

Med

ical

lite

racy

–0.6

±0.

7–0

.1 ±

0.5

–0.1

±0.

5Ps

ycho

logi

cal l

itera

cy–0

.7 ±

1.1

–0.5

±1.

0–0

.0 ±

0.9

Life

styl

e lit

erac

y0.

6 ±

0.9

–0.0

±0.

50.

1 ±

0.8

CBT

lite

racy

–1.1

±2.

0–2

.0 ±

2.4

0.1

±1.

6

Not

e: t

he t

able

sho

ws

resu

lts b

y IT

T. T

heau

thor

s al

so p

rovi

de c

ompa

rabl

e ta

bles

for

com

plet

ers

only

and

com

plet

ers

scor

ing

≥16

on t

he C

ESD

P, bu

t th

ese

are

not

show

n he

re.

Pref

eren

ce fo

r in

terv

entio

n or

inco

mpa

tibili

tybe

twee

n pr

efer

ence

and

allo

catio

n w

as n

ot a

pred

icto

r of

cha

nge

on t

he C

ESD

P.

Pre–

post

ESs

for

CES

DP

wer

e 0.

4, 0

.4 a

nd0.

1 fo

r th

e M

oodG

ym, B

lue

Page

s an

dco

ntro

l gro

ups,

res

pect

ivel

y, in

the

ITT

anal

ysis.

For

com

plet

ers

the

ESs

wer

e 0.

6,0.

5 an

d 0.

1, a

nd fo

r co

mpl

eter

s w

ith C

ESD

scor

es o

f ≥16

the

ESs

wer

e 0.

9, 0

.75

and

0.25

cont

inue

d

Appendix 6

116 TA

BLE

31

Resu

lts o

f rep

orte

d ou

tcom

es (

psyc

holo

gica

l sym

ptom

s an

d in

terp

erso

nal a

nd s

ocia

l fun

ctio

ning

: RCT

s (c

ont’d

)

Stud

yR

esul

tsO

ther

out

com

e in

form

atio

n

Blue

Pag

es v

s M

oodG

ymM

oodG

ym v

s Co

ntro

lBl

ue p

ages

vs

Cont

rol

CES

DP

–0.3

(–

2.6

to 2

.0)

3.2*

(0.9

to

5.4

2.9*

(0.6

to

5.2)

ATQ

–2.8

(–

7.2

to 1

.5)

6.1*

(1.9

to

10.4

)3.

3 (–

1.1

to 7

.7)

Med

ical

lite

racy

–0.5

* (–

0.7

to –

0.4)

0.0

(–0.

1 to

0.2

)–0

.5*

(–0.

6 to

0.3

)Ps

ycho

logi

cal l

itera

cy–0

.3*

(–0.

5 to

–0.

0)–0

.4*

(–0.

7 to

–0.

2)–0

.7*

(–1.

0 to

–0.

4)Li

fest

yle

liter

acy

–0.5

* (–

0.7

to –

0.4)

0.1

(–0.

3 to

0.0

)–0

.7*

(–0.

9 to

–0.

5)C

BT li

tera

cy0.

9* (0

.4 t

o 1.

4)–2

.1*

(–2.

6 to

–1.

6)–1

.2*

(–1.

7, t

o –0

.7)

All

resu

lts r

emai

ned

signi

fican

t w

ith a

djus

tmen

t us

ing

Bonf

erro

ni c

orre

ctio

n. *

The

mea

n di

ffere

nce

was

sig

nific

ant

(n<

0.05

). In

the

ITT

con

ditio

n, t

he p

erce

ntag

e of

clin

ical

cas

es (C

ESD

P >

16) w

as 5

0% (B

lue

Page

s), 5

4%(M

oodG

ym) a

nd 6

1% (c

ontr

ol) a

t po

stin

terv

entio

n, r

epre

sent

ing

a dr

op o

f 20%

, 25%

and

8%

, res

pect

ivel

y, fr

omca

sene

ss le

vels

befo

re in

terv

entio

n.

Cla

rke,

200

297Se

lf-re

port

ed d

epre

ssio

n ou

tcom

es (

CES

DP

) fo

r to

tal s

ampl

e an

d su

bsam

ples

(m

ean

±SD

)

Base

line

8 w

eeks

16 w

eeks

32 w

eeks

Sign

ifica

nce

Tota

l sam

ple

CC

BT (n

= 1

44)

30.5

±12

.322

.4 ±

11.4

21.7

±13

.321

.3 ±

13.1

0.86

Con

trol

(n =

155

)31

.2 ±

11.7

22.4

±13

.522

.7 ±

12.6

23.0

±14

.0

Dep

ress

ed c

ases

CC

BT (n

= 1

07)

30.7

±12

.923

.7 ±

11.9

23.0

±13

.522

.2 ±

12.8

0.12

*C

ontr

ol (n

= 1

16)

31.3

±11

.523

.7 ±

14.0

23.2

±12

.825

.5 ±

14.2

Non

-dep

ress

ed c

ases

CC

BT (n

= 3

7)30

.0 ±

10.6

18.6

±8.

717

.8 ±

12.3

18.6

±13

.9C

ontr

ol (n

= 3

9)30

.7 ±

12.4

19.1

±11

.921

.0 ±

12.0

16.0

±10

.8

*p-V

alue

for

the

inte

ract

ion

term

of g

ende

r �

trea

tmen

t gr

oup

�tim

e (t

est

of w

heth

er t

he e

ffect

of t

reat

men

t on

CES

DP

scor

e ch

ange

diff

ered

by

gend

er).

The

aut

hors

also

pro

vide

d se

para

te a

naly

ses

by h

igh

and

low

bas

elin

e C

ES-D

sco

re,

gend

er a

nd a

ge g

roup

, but

non

e of

the

se w

assig

nific

ant

cont

inue

d


117


TA

BLE

31

Resu

lts o

f rep

orte

d ou

tcom

es (

psyc

holo

gica

l sym

ptom

s an

d in

terp

erso

nal a

nd s

ocia

l fun

ctio

ning

: RCT

s (c

ont’d

)

Stud

yR

esul

tsO

ther

out

com

e in

form

atio

n

cont

inue

d

Pho

bia/

pani

c: in

clud

ed s

tudi

es

Mar

ks, 2

00488

Out

com

e ra

ting

s, p

re-

and

post

-tre

atm

ent

(mea

n ±

SD)

Pre

Post

Impr

ovem

ent

ES

FF (

n=

20)

sel

f-ra

ted

Mai

n pr

oble

m7.

4 ±

0.8

3.9

±2.

047

.4 ±

25.7

4.3

Goa

ls7.

1 ±

1.1

2.9

±1.

657

.6 ±

2.5

3.8

FQ g

loba

l pho

bia

6.1

±1.

33.

8 ±

2.3

37.1

±33

.7

1.7

WSA

tot

al15

.5 ±

7.7

10 ±

10.5

45.1

±45

.30.

7

FF b

lind

asse

ssor

Mai

n pr

oble

mN

R3.

1 ±

1.5

NR

NR

Goa

lsN

R2.

9 ±

1.9

NR

NR

FQ g

loba

l pho

bia

5.4

±1.

13.

1 ±

1.2

42.8

±19

.22.

1W

SA t

otal

14.6

±5.

97.

2 ±

5.8

52.8

±24

.91.

2

Clin

icia

n (n

= 2

9) s

elf-

rate

dM

ain

prob

lem

7.3

±1.

03.

6 ±

1.3

50.1

±21

.43.

7G

oals

7.0

±1.

23.

1 ±

1.7

55.0

±25

.35.

7FQ

glo

bal p

hobi

a6.

7 ±

1.2

3.3

±1.

849

.2 ±

27.9

2.8

WSA

tot

al17

.6 ±

8.5

11.8

±8.

230

.4 ±

37.6

0.

7

Clin

icia

n, b

lind

asse

ssor

Mai

n pr

oble

mN

R3.

6 ±

1.3

NR

NR

Goa

lsN

R3.

1 ±

1.7

NR

NR

FQ g

loba

l pho

bia

5.7

±1.

33.

2 ±

1.3

41.7

±20

.11.

9W

SA t

otal

17.5

±8.

310

.0 ±

7.1

46.7

±24

.20.

9

Rela

xatio

n (n

= 1

6) S

elf r

ated

Mai

n pr

oble

m7.

1 ±

1.0

6.4

±1.

410

.2 ±

16.4

0.7

Goa

ls7.

1 ±

1.2

6.7

±1.

67.

4 ±

9.4

0.3

FQ g

loba

l pho

bia

6.6

±1.

35.

7 ±

1.9

13.5

±23

.10.

7W

SA t

otal

15.4

±8.

411

.9 ±

7.7

16.9

±35

.40.

4

Rela

xatio

n, b

lind

asse

ssor

Mai

n pr

oble

mN

R5.

8 ±

1.1

NR

NR

Goa

lsN

R6.

8 ±

1.1

NR

NR

FQ g

loba

l pho

bia

5.6

±1.

25.

3 ±

1,3

5.8

±17

.30.

2W

SA t

otal

15.9

±7.

815

.3 ±

7.1

–1.0

±33

0.1

3-m

onth

follo

w-u

p: 5

2 pa

tient

s ha

d no

oth

ertr

eatm

ent

afte

r 1-

mon

th fo

llow

-up,

3-m

onth

follo

w-u

p ra

tings

wer

e re

ceiv

ed fr

om 3

4(3

8% o

f the

orig

inal

) (11

FF,

19 C

, 4 R

), on

repe

ated

mea

sure

s an

alys

es, F

F an

d cl

inic

ian

impr

oved

sig

nific

antly

and

sim

ilarly

from

pret

reat

men

t to

3-m

onth

follo

w-u

p on

all

mea

sure

s (a

ll p

<0.

001)

Clin

icia

n tim

e: m

ean

tota

l the

rapi

st c

onta

cttim

e pe

r pa

tient

(min

utes

): FF

76

±43

,cl

inic

ian

283

±11

8, r

elax

atio

n 76

±22

(p

<0.

001)

Dro

pout

s: m

ore

FF p

atie

nts

drop

ped

out

than

clin

icia

n pa

tient

s (4

3% v

s 24

%)

(C, C

linic

ian;

R, r

elax

atio

n)

Appendix 6

118 TA

BLE

31

Resu

lts o

f rep

orte

d ou

tcom

es (

psyc

holo

gica

l sym

ptom

s an

d in

terp

erso

nal a

nd s

ocia

l fun

ctio

ning

: RCT

s (c

ont’d

)

Stud

yR

esul

tsO

ther

out

com

e in

form

atio

n

Schn

eide

r,20

0590

Out

com

e ra

ting

s at

wee

ks 0

, 10

and

14 (

mea

n ±

SD)

Wee

k 0

Wee

k 10

Wee

k 14

Wee

k 0–

14W

eek

0–14

diffe

renc

eES

FF s

elf-

repo

rted

Mai

n pr

oble

m7.

0 ±

1.2

4.7

±2.

04.

1 ±

2.1

2.9*

** (2

.1 t

o 3.

6)2.

4M

ain

goal

7.0

±1.

24.

5 ±

2.4

4.2

±2.

22.

9***

(2.0

to

3.8)

2.4

FQ g

loba

l pho

bia

6.3

±1.

4FQ

mai

n ph

obia

7.6

±0.

75.

0 ±

2.4

4.1

±2.

23.

6***

(2

.8 t

o 4.

4)5.

1FQ

tot

al p

hobi

a48

±34

35 ±

2629

±25

17.5

***

(9.0

to

26.1

)0.

5

FQ a

nxie

ty/d

epre

ssio

n To

tal

26 ±

1215

±11

11 ±

1015

.1**

* (1

1.2

to 1

9.1)

1.2

WSA

tot

al23

±11

15 ±

1012

±9.

89.

9***

(7

.0 t

o 12

.9)

0.9

FF a

sses

sor

Mai

n pr

oble

m6.

0 ±

1.4

4.0

±2.

13.

6 ±

2.1

2.3*

** (1

.7 t

o 3.

0)1.

6M

ain

goal

7.6

±0.

94.

5 ±

2.8

4.3

±2.

83.

3***

(2.2

to

4.4)

3.7

FQ g

loba

l pho

bia

6.0

±1.

44.

0 ±

2.1

3.5

±2.

12.

0***

(1.4

to

2.5)

1.7

Glo

bal i

mpr

essio

n1.

7 ±

2.0

1.6

±1.

1W

ork/

soci

al t

otal

17 ±

9.2

11.2

±9.

011

.0 ±

9.7

6.4*

** (3

.5 t

o 9.

2)0.

7

MA

self-

repo

rted

Mai

n pr

oble

m7.

2 ±

1.4

4.9

±2.

04.

9 ±

1.7

2.2*

** (1

.4 t

o 2.

9)1.

6M

ain

goal

7.3

±1.

64.

8 ±

2.0

4.5

±1.

93.

0***

(1.9

to

4.1)

1.9

FQ g

loba

l pho

bia

6.3

±1.

5FQ

mai

n ph

obia

7.6

±0.

75.

2 ±

2.5

4.2

±2.

23/

6**

(1.7

to

5.4)

5.1

FQ t

otal

pho

bia

59 ±

2940

±22

45 ±

2518

.2**

(6.8

to

29.5

)0.

5

FQ a

nxie

ty/d

epre

ssio

n To

tal

28 ±

1120

±12

21 ±

126.

8†

(–0.

7 to

14.

4)0.

7W

SA t

otal

21 ±

2012

±9.

115

±11

6.3*

* (1

.9 t

o 10

.7)

0.6

MA

asse

ssor

Mai

n pr

oble

m6.

9 ±

1.0

4.9

±1.

95.

4 ±

2.2

1.5*

* (0

.5 t

o 2.

5)1.

5M

ain

goal

7.7

±0.

75.

0 ±

2.5

5.7

±2.

51.

9**

(0.6

to

3.3)

2.7

FQ g

loba

l pho

bia

6.9

±1.

04.

9 ±

1.9

5.3

±2.

21.

6**

(0.6

to

2.6)

1.6

Glo

bal i

mpr

essio

n2.

3 ±

1.0

2.1

±1.

1W

ork/

soci

al t

otal

20 ±

8.4

14 ±

9.8

14 ±

105.

2**

(1.6

to

8.9)

0.6

Diff

eren

ce: m

ean

(95%

CI):

ES:

pre

trea

tmen

t m

ean

– po

st-t

reat

men

t m

ean/

pret

reat

men

t SD

, ***

p <

0.0

01,

**p

< 0

.01,

†p

< 0

.1.

All

thre

e m

ajor

pho

bia

type

s im

prov

edsig

nific

antly

(p <

0.0

1), w

ith a

tre

nd fo

rag

orap

hobi

cs t

o im

prov

e sig

nific

antly

mor

eth

an s

peci

fic p

hobi

cs. C

ompa

rison

s m

ade

with

out

com

es fr

om o

ther

FF

tria

ls(K

enw

right

,86M

arks

,88,8

9 ) im

prov

emen

tssim

ilar

in F

F gr

oups

cont

inue

d


119


TA

BLE

31

Resu

lts o

f rep

orte

d ou

tcom

es (

psyc

holo

gica

l sym

ptom

s an

d in

terp

erso

nal a

nd s

ocia

l fun

ctio

ning

: RCT

s (c

ont’d

)

Stud

yR

esul

tsO

ther

out

com

e in

form

atio

n

cont

inue

d

Pho

bia/

pani

c: o

ther

stu

dies

Car

lbrin

g,20

0192

Pani

c di

ary

for

the

trea

tmen

t (C

CB

T)

and

WLC

gro

ups

(mea

n ±

SD)

CCBT

WLC

Inte

ract

ion

F 1,3

9

Dai

ly a

nxie

tyPr

e30

.85

±15

.828

.56

±15

.314

.85*

**Po

st15

.91

±13

.728

.18

±14

.1

Full-

blow

n pa

nic

atta

cks

per w

eek:

freq

uenc

yPr

e2.

19 ±

4.05

2.25

±2.

84.

58*

Post

0.43

±1.

082.

33 ±

3.34

Full-

blow

n pa

nic

atta

cks

per w

eek:

dur

atio

n (m

inut

es)

Pre

35.7

±56

.644

.2

±61

.54.

22**

*Po

st3.

63 ±

8.9

43.2

8 ±

73.5

Full-

blow

n pa

nic

atta

cks

per w

eek:

inte

nsity

Pre

46.5

±

31.7

434

.68

±24

.39.

89**

Post

12.6

9 ±

24.2

32.9

4 ±

28.6

Lim

ited

sym

ptom

att

ack

per w

eek:

freq

uenc

yPr

e2.

7 ±

2.1

4.1

±5.

80.

003

Post

2.0

±3.

23.

4 ±

6.7

Lim

ited

sym

ptom

att

ack

per w

eek:

dur

atio

n (m

inut

es)

Pre

49.5

±92

.346

.6 ±

60.2

1.6

Post

14.5

±25

.039

.9 ±

49.5

Lim

ited

sym

ptom

att

ack

per w

eek:

inte

nsity

Pre

29.1

2 ±

17.0

30.4

4 ±

19.3

5.49

*Po

st19

.6±

17.1

34.4

5 ±

23.7

***p

< 0

.001

, **p

< 0

.01,

*p

< 0

.5.

The

mea

n sc

ore

for

TCS

was

42.

6 ±

5.6

(max

imum

50,

ran

ge 2

7–50

), th

eref

ore

over

all r

atin

g of

tre

atm

ent

cred

ibili

ty w

ashi

gh, a

lthou

gh n

ot c

orre

late

d w

ith a

nyou

tcom

e m

easu

re o

r dr

oppi

ng o

ut o

f the

stud

y

Appendix 6

120 TA

BLE

31

Resu

lts o

f rep

orte

d ou

tcom

es (

psyc

holo

gica

l sym

ptom

s an

d in

terp

erso

nal a

nd s

ocia

l fun

ctio

ning

: RCT

s (c

ont’d

)

Stud

yR

esul

tsO

ther

out

com

e in

form

atio

n

BSQ

, AC

Q, M

I, B

AI,

BD

I, Q

OLI

and

MA

DR

S-SR

for

the

trea

tmen

t (C

CB

T)

and

cont

rol (

WLC

) gr

oups

(mea

n ±

SD)

CCBT

WLC

Inte

ract

ion

F 1,3

9

BSQ

Pre

45.3

±

7.5

46.4

±8.

7Po

st29

.0

±10

.345

.1 ±

12.0

34.9

9***

AC

QPr

e31

.7

±6.

532

.9 ±

9.4

Post

22.4

3 ±

6.0

30.9

±9.

616

.38*

**M

I alo

nePr

e64

.4

±23

.264

.0 ±

21.9

Post

47.0

±

17.4

61.4

±20

.712

.03*

*M

I acc

ompa

nied

Pre

44.4

±

13.1

46.8

±12

.7Po

st37

.0

±10

.944

.3 ±

14.6

3.08

†BA

IPr

e19

.3

±6.

221

.5 ±

10.0

Post

9.8

±8.

421

.2 ±

10.4

10.9

7**

BDI

Pre

11.4

±

3.7

13.1

±6.

2Po

st5.

0 ±

3.6

12.1

±7.

712

.75*

**Q

OLI

Pre

1.7

±1.

11.

4 ±

1.1

Post

2.2

±1.

21.

3 ±

1.2

9.52

**M

AD

RS-S

RPr

e13

.1

±4.

412

.8 ±

3.7

Post

7.1

±4.

714

.1 ±

6.4

17.0

2***

***p

< 0

.001

, **p

< 0

.01,

†p

< 0

.1.

Car

lbrin

g,20

0394

Pool

ed w

ithi

n ES

, mai

n ef

fect

s an

d in

tera

ctio

ns fo

r th

e pa

nic

diar

y at

pre

- an

d po

st-t

reat

men

t fo

r th

etw

o tr

eatm

ent

grou

ps (

mea

n ±

SD)

Mea

sure

Gro

upPr

ePo

stES

wM

ain

effe

ctIn

tera

ctio

n

Tim

eG

roup

Tim

e×

Gro

upF 1

,20

F 1,2

0F 1

,20

Anx

iety

C

CBT

18.4

±15

18.0

±16

0.03

0.6

1.7

0.4

AR

27.4

±8.

823

.8 ±

16.9

0.28

Lim

ited

sym

ptom

att

acks

per

wee

kFr

eque

ncy

CC

BT1.

8 ±

2.3

0.9

±1.

30.

538.

2**

1.5

0.6

AR

3.5

±3.

91.

9 ±

2.9

0.47

Inte

nsity

CC

BT16

.3 ±

23.9

14.5

±25

.70.

070.

30.

10.

0A

R19

.6 ±

17.2

17.8

±20

.90.

09D

urat

ion

(min

utes

)C

CBT

3.8

±5.

45.

9 ±

12.2

–0.2

41.

01.

32.

7A

R15

.2 ±

22.6

6.7

±12

.00.

49

The

TC

S sc

ore

was

34.

9 ±

9.5

for

the

CBT

grou

p an

d 32

.6 ±

7.4

for

the

AR

grou

p.Pe

rcei

ved

trea

tmen

t cr

edib

ility

was

not

corr

elat

ed w

ith im

prov

emen

t or

with

drop

ping

out

, but

was

cor

rela

ted

with

the

chan

ge s

core

s on

the

fear

bar

omet

er

(r22

= 0

.463

, p<

0.0

5). T

he o

vera

ll ES

was

0.42

for

the

CC

BT g

roup

and

0.7

1 fo

r th

e A

Rgr

oup.

An

inde

pend

ent

sam

ples

tes

t sh

owed

that

the

diff

eren

ce d

id n

ot r

each

sta

tistic

alsig

nific

ance

(t23

= –

1.98

4; p

= 0

.057

) cont

inue

d


121


TA

BLE

31

Resu

lts o

f rep

orte

d ou

tcom

es (

psyc

holo

gica

l sym

ptom

s an

d in

terp

erso

nal a

nd s

ocia

l fun

ctio

ning

: RCT

s (c

ont’d

)

Stud

yR

esul

tsO

ther

out

com

e in

form

atio

n

Mea

sure

Gro

upPr

ePo

stES

wM

ain

effe

ctIn

tera

ctio

n

Tim

eG

roup

Tim

e×

Gro

upF 1

,20

F 1,2

0F 1

,20

Full-

blow

n pa

nic

atta

cks

per w

eek

Freq

uenc

yC

CBT

2.3

±2.

41.

3 ±

1.6

0.51

7.6*

0.8

0.3

AR

3.5

±3.

01.

9 ±

3.1

0.52

Inte

nsity

CC

BT31

.6 ±

24.2

32.4

±24

.1–0

.03

3.5†

0.2

4.0†

AR

41.3

±24

.220

.1 ±

24.1

0.88

Dur

atio

n (m

inut

es)

CC

BT22

.2 ±

40.4

10.4

±16

.50.

413.

6†0.

50.

7A

R12

.3 ±

13.7

7.9

±9.

60.

38Fe

ar b

arom

eter

CC

BT84

.5 ±

15.6

49.8

±33

.81.

4026

.7**

*1.

70.

1A

R67

.6 ±

30.3

37.2

±37

.00.

90

***p

< 0

.01,

**p

< 0

.01,

*p

< 0

.05,

†p

< 0

.1.

Pool

ed w

ithi

n ES

, mai

n ef

fect

s an

d in

tera

ctio

ns fo

r th

e qu

esti

onna

ires

use

d at

pre

- an

d po

st-t

reat

men

tfo

r th

e tw

o tr

eatm

ent

grou

ps (

mea

n ±

SD)

Mea

sure

Gro

upPr

ePo

stES

wM

ain

effe

ctIn

tera

ctio

n

Tim

e G

roup

Tim

e×

Gro

upF 1

,20

F 1,2

0F 1

,20

BSQ

CC

BT47

.5 ±

13.4

35.7

±16

.20.

7919

.2**

*0.

10.

0A

R49

.2 ±

11.5

37.9

±12

.80.

93A

CQ

CC

BT33

.3 ±

9.8

25.8

±8.

30.

8320

.7**

*0.

00.

9A

R32

.3 ±

7.1

27.4

±8.

20.

64M

I alo

neC

CBT

71.2

±26

.954

.7 ±

26.0

0.62

25.1

***

0.7

0.2

AR

62.6

±17

.449

.1 ±

11.2

0.95

MI a

ccom

pani

edC

CBT

57.5

±21

.645

.9 ±

19.1

0.57

19.2

***

4.6*

0.3

AR

43.0

±9.

333

.9 ±

5.7

1.20

BAI

CC

BT19

.6 ±

12.4

15.2

±13

.10.

3417

.0**

*0.

31.

6A

R19

.2 ±

4.1

11.0

±7.

61.

40BD

IC

CBT

9.2

±9.

98.

4 ±

110.

085.

7*0.

42.

8A

R13

.3 ±

5.1

8.6

±3.

91.

05Q

OLI

aC

CBT

1.3

±1.

72.

0 ±

1.4

0.45

3.9†

1.6

0.2

AR

2.0

±0.

92.

4 ±

1.2

0.38

***p

<0.

001,

*p

<0.

05, †

p<

0.1.

A h

ighe

r va

lue

indi

cate

s a

high

er q

ualit

y of

life

.

cont

inue

d

Appendix 6

122 TA

BLE

31

Resu

lts o

f rep

orte

d ou

tcom

es (

psyc

holo

gica

l sym

ptom

s an

d in

terp

erso

nal a

nd s

ocia

l fun

ctio

ning

: RCT

s (c

ont’d

)

Stud

yR

esul

tsO

ther

out

com

e in

form

atio

n

Car

lbrin

g,20

0496

Coh

en’s

poo

led

wit

hin-

grou

p ES

wfo

r th

e qu

esti

onna

ires

use

d pr

e- a

nd p

ost-

trea

tmen

t an

d 1-

year

follo

w-u

p fo

r th

e tw

o tr

eatm

ent

grou

ps (

mea

n ±

SD)

Mea

sure

Gro

upPr

ePo

stFU

ESw

Pre

to P

ost

Pre

to F

U

BSQ

CC

BT48

.7 ±

11.7

31.8

±11

.632

.1 ±

11.5

1.45

*1.

43*

TCBT

52.6

±10

.831

.3 ±

9.1

31.9

±10

.72.

14*

1.92

*A

CQ

CC

BT34

.5 ±

8.6

23.8

±9.

023

.0 ±

9.6

1.22

*1.

27*

TCBT

34.6

±9.

323

.6 ±

7.2

23.1

±8.

61.

33*

1.29

*M

I alo

neC

CBT

2.2

±0.

91.

7 ±

0.7

1.6

±0.

70.

64*

0.68

*TC

BT2.

7 ±

0.9

1.9

±0.

82.

0 ±

0.9

0.85

*0.

76*

MI a

ccom

pani

edC

CBT

1.8

±0.

51.

4 ±

0.4

1.5

±0.

50.

71*

0.63

*TC

BT2.

1 ±

0.8

1.5

±0.

61.

5 ±

0.6

0.84

*0.

81*

BAI

CC

BT18

.7 ±

10.3

10.9

±7.

110

.7 ±

7.9

0.90

*0.

88*

TCBT

24.5

±10

.412

.3 ±

7.7

12.3

±10

.11.

35*

1.18

*BD

IC

CBT

11.8

±7.

86.

6 ±

5.5

6.2

±5.

40.

78*

0.83

*TC

BT15

.9 ±

9.0

10.2

±7.

08.

8 ±

6.7

0.71

*0.

91*

MA

DRS

CC

BT13

.4 ±

5.3

8.6

±5.

78.

1 ±

5.7

0.87

*0.

97*

TCBT

16.0

±4.

310

.4 ±

5.6

10.1

±6.

91.

15*

1.05

*Q

OLI

CC

BT1.

4 ±

1.7

2.0

±1.

41.

9 ±

1.4

–0.3

7*–0

.31*

TCBT

0.9

±1.

61.

7 ±

1.5

1.7

±1.

3–0

.48*

–0.5

0*Fr

ee fr

om p

anic

diso

rder

CC

BT0%

80%

92%

TCBT

0%67

%88

%

*All

p-va

lues

<0.

025

with

one

-tai

led

paire

d sa

mpl

e t-

test

pre

- vs

pos

t-tr

eatm

ent

or fo

llow

-up.

No

diffe

renc

es b

etw

een

post

-tre

atm

ent

and

follo

w-u

p. T

he o

vera

ll ES

was

0.9

9 fo

r th

eTC

BT g

roup

and

0.7

8 fo

r th

e C

CBT

gro

uppo

st-t

reat

men

t, an

d 0.

93 a

nd 0

.80

resp

ectiv

ely,

at

follo

w-u

p. A

t 1-

year

follo

w-u

p92

% in

the

CC

BT g

roup

and

88%

in t

heTC

BT g

roup

no

long

er m

et c

riter

ia fo

r PD

.T

he T

CS

did

not

pred

ict

outc

ome

exce

pt in

two

case

s. F

or b

oth

the

CC

BT a

nd T

CBT

grou

p th

e TC

S di

d pr

edic

t, sig

nific

antly

,ch

ange

sco

res

for

the

BSQ

Fras

er, 2

00198

Out

com

e m

easu

res

for

thre

e-se

ssio

n gr

oup

for

pret

reat

men

t, p

ost-

trea

tmen

t an

d fo

llow

-up

asse

ssm

ents

(mea

n ±

SD)

and

ES

Pre

Post

FUES

Pre

to P

ost

Pre

to F

U

BAT

4.7

±3.

7 9.

0 ±

5.6

9.8

±6.

31.

161.

38SU

DS

64.0

±29

.146

.0 ±

32.1

33.0

±33

.00.

621.

10SP

Q25

.1 ±

3.8

23.5

±4.

621

.5 ±

5.6

0.42

0.95

FQ m

ain

7.7

±0.

87.

1 ±

1.6

5.9

±2.

50.

752.

25FQ

glo

bal

5.8

±2.

04.

7 ±

2.3

3.9

±1.

90.

550.

95PT

pro

blem

5.5

±2.

64.

8 ±

2.0

3.7

±1.

50.

270.

70PT

tot

al28

.1 ±

3.4

23.1

±7.

319

.3 ±

6.1

1.47

2.59

WA

RS t

otal

9.5

±7.

86.

9 ±

5.7

6.7

±7.

30.

330.

36

The

aut

hors

also

pro

vide

a t

able

of t

he m

eans

and

stan

dard

dev

iatio

ns o

f the

typ

es o

fvi

cario

us e

xpos

ure

beha

viou

rs p

erfo

rmed

durin

g th

e fir

st, t

hird

and

last

ses

sions

of

trea

tmen

t, an

d th

e su

m o

f all

sess

ions

for

each

gro

up

cont

inue

d


123


TA

BLE

31

Resu

lts o

f rep

orte

d ou

tcom

es (

psyc

holo

gica

l sym

ptom

s an

d in

terp

erso

nal a

nd s

ocia

l fun

ctio

ning

: RCT

s (c

ont’d

)

Stud

yR

esul

tsO

ther

out

com

e in

form

atio

n

Out

com

e m

easu

res

for

six-

sess

ion

grou

p fo

r pr

etre

atm

ent,

pos

t-tr

eatm

ent

and

follo

w-u

p as

sess

men

ts(m

ean

±SD

) an

d ES

Pre

Post

FUES

Pre

to P

ost

Pre

to F

U

BAT

5.6

±3.

410

.4 ±

5.2

13.7

±4.

91.

42.

38SU

DS

72.0

±21

.048

.0 ±

25.0

37.0

±19

.01.

101.

67SP

Q23

.1 ±

5.3

19.6

±6.

317

.3 ±

6.6

0.66

1.10

FQ m

ain

8.0

±0.

16.

1 ±

2.6

6.1

±2.

42.

302.

30FQ

glo

bal

5.1

±2.

04.

4 ±

2.0

3.9

±2.

10.

350.

60PT

pro

blem

5.5

±1.

94.

2 ±

2.3

2.9

±2.

00.

701.

37PT

tot

al27

.3 ±

5.1

20.5

±8.

0118

.3 ±

11.8

1.33

1.76

WA

RS t

otal

11.1

±10

.96.

1 ±

10.9

4.1

±6.

20.

460.

64

Not

e: t

he a

utho

rs c

lass

ified

an

ES o

f 0.2

0–0.

49 a

s be

ing

smal

l, 0.

50–0

.79

as b

eing

med

ium

and

≥0.

8 as

larg

e.

Gilr

oy, 2

000,

107

Gilr

oy, 2

00399

BA

T, S

UD

S, S

Q a

nd F

Q-M

ain

(mea

n ±

SD)

and

ES

Gro

up

Phas

eBA

TSU

DS

SQFQ

mai

nFQ

glo

bal

Live

Pre

3.2

±2.

778

.3±

12.1

23.3

±4.

87.

9 ±

0.3

5.7

±2.

0Po

st14

.8 ±

3.3

28.1

±23

.114

.8 ±

6.0

3.8

±2.

22.

8 ±

2.0

3-m

onth

FU

12.6

±5.

428

.4 ±

27.6

13.9

±7.

73.

6 ±

2.6

3.2

±2.

433

-mon

th F

U14

.0 ±

6.8

40.5

±25

.913

.7 ±

6.5

4.2

±2.

72.

6 ±

1.8

ESPr

e–po

st3.

92.

71.

62.

61.

5Pr

e–3-

mon

th2.

22.

31.

52.

31.

1Pr

e–33

-mon

th2.

11.

91.

71.

91.

6C

AVE

Pre

4.4

±2.

962

.2 ±

21.1

23.7

±4.

67.

7 ±

0.6

5.8

±1.

2Po

st10

.9 ±

4.7

29.3

±20

.316

.5 ±

5.2

5.0

±2.

03.

6 ±

1.6

3-m

onth

FU

11.3

±5.

526

.8 ±

21.6

15.7

±6.

44.

2 ±

1.9

3.4

±1.

633

-mon

th F

U10

.1 ±

5.4

32.8

±21

.616

.7 ±

6.4

4.8

±2.

62.

8 ±

1.5

ESPr

e–po

st1.

71.

61.

51.

81.

6Pr

e–3-

mon

th1.

61.

71.

42.

51.

7Pr

e–33

-mon

th1.

31.

41.

31.

52.

2Re

lax

Pre

2.7

±3.

076

.4 ±

19.8

23.5

±5.

77.

7 ±

0.6

6.1

±1.

7Po

st5.

7 ±

5.4

61.2

±23

.521

.0 ±

6.8

6.5

±1.

55.

3 ±

2.1

3-m

onth

FU

4.36

±4.

651

.5 ±

30.4

18.4

±7.

65.

6 ±

2.4

4.2

±2.

233

-mon

th F

Ua

19.4

±8.

66.

0 ±

2.7

4.3

±2.

4ES

Pre–

post

0.7

0.7

0.4

1.1

0.4

Pre–

3-m

onth

0.4

1.0

0.7

1.2

1.1

Pre–

33-m

onth

0.6

0.9

0.9

NR

cont

inue

d

Appendix 6

124 TA

BLE

31

Resu

lts o

f rep

orte

d ou

tcom

es (

psyc

holo

gica

l sym

ptom

s an

d in

terp

erso

nal a

nd s

ocia

l fun

ctio

ning

: RCT

s (c

ont’d

)

Stud

yR

esul

tsO

ther

out

com

e in

form

atio

n

FQ-G

loba

l, P

hobi

c P

robl

em, P

T T

otal

, WA

RS

Tota

l (m

ean

±SD

) an

d ES

Gro

upPh

ase

Phob

ic p

robl

emPT

tot

alW

ARS

tota

lH

elpf

ulne

ssAc

cept

ance

Live

Pre

5.9

±1.

926

.6 ±

4.9

7.7

±4.

3Po

st2.

3 ±

1.5

11.8

±8.

33.

2 ±

2.9

6.4

±1.

16.

4 ±

1.1

3-m

onth

FU

3.1

±2.

511

.5 ±

9.8

1.6

±3.

06.

5 ±

1.4

6.3

±1.

033

-mon

th F

U1.

9 ±

2.3

11.3

±10

.74.

3 ±

5.0

5.0

±1.

85.

7 ±

1.7

ESPr

e–po

st2.

32.

21.

2Pr

e–3-

mon

th1.

32.

01.

7Pr

e–33

-mon

th2.

01.

80.

7C

AVE

Pre

6.0

±1.

828

.6 ±

3.8

8.9

±5.

6Po

st3.

4 ±

1.2

15.2

±6.

54.

0 ±

3.5

4.8

±1.

75.

1 ±

1.7

3-m

onth

FU

3.8

±2.

014

.5 ±

8.6

3.0

±5.

45.

0 ±

1.8

5.1

±1.

833

-mon

th F

U2.

2 ±

1.9

13.5

±7.

43.

7 ±

4.5

4.8

±1.

74.

9 ±

1.7

ESPr

e–po

st1.

72.

51.

1Pr

e–3-

mon

th1.

22.

11.

1Pr

e–33

-mon

th2.

12.

61.

0Re

lax

Pre

5.8

±2.

030

.3 ±

1.7

8.4

±4.

8Po

st4.

9 ±

2.1

26.1

±3.

87.

1 ±

3.1

3.5

±1.

74.

7 ±

1.5

3-m

onth

FU

4.5

±2.

622

.3 ±

7.6

6.7

±7.

63.

8 ±

1.8

4.0

±1.

933

-mon

th F

U4.

9 ±

2.7

20.2

±9.

48.

1 ±

8.2

3.3

±1.

73.

5 ±

1.8

ESPr

e-po

st0.

41.

40.

3Pr

e–3-

mon

th0.

61.

50.

3Pr

e–33

-mon

th0.

41.

50.

0a

Ow

ing

to t

he n

umbe

r of

par

tial a

ttrit

ion

case

s in

the

PM

R gr

oup

at 3

3-m

onth

follo

w-u

p, t

his

grou

p w

as e

xclu

ded

from

ana

lyse

s of

BAT

and

SU

DS.

cont

inue

d


125


TA

BLE

31

Resu

lts o

f rep

orte

d ou

tcom

es (

psyc

holo

gica

l sym

ptom

s an

d in

terp

erso

nal a

nd s

ocia

l fun

ctio

ning

: RCT

s (c

ont’d

)

Stud

yR

esul

tsO

ther

out

com

e in

form

atio

n

Hea

ding

,20

0110

1O

utco

me

mea

sure

s fo

r th

e LG

E gr

oup

for

pret

reat

men

t, p

ost-

trea

tmen

t an

d fo

llow

-up

asse

ssm

ents

(mea

n ±

SD)

and

ESPr

ePo

stFU

ESPr

e to

Pos

tPr

e to

FU

BAT

5.62

±3.

7512

.69

±5.

8414

.00

±6.

111.

92.

2SU

DS

60.6

0 ±

18.8

30.7

0 ±

18.1

28.4

9 ±

12.6

1.6

1.7

SPQ

23.7

7 ±

3.63

19.0

8 ±

4.11

16.6

2 ±

5.09

1.3

2.0

FQ m

ain

7.69

±0.

754.

69 ±

2.35

4.62

±2.

214.

04.

1FQ

glo

bal

5.15

±1.

863.

31 ±

1.44

2.92

±1.

041.

01.

2PT

pro

blem

5.38

±2.

023.

31 ±

1.79

2.54

±1.

391.

01.

4PT

tot

al27

.00

±3.

1416

.38

±6.

1416

.31

±5.

923.

43.

4W

ARS

tot

al8.

42 ±

6.65

5.92

±5.

163.

42 ±

3.03

0.4

0.8

Out

com

e m

easu

res

for

CA

VE

grou

p fo

r pr

etre

atm

ent,

pos

t-tr

eatm

ent

and

follo

w-u

p as

sess

men

ts

(mea

n ±

SD)

and

ESPr

ePo

stFU

ESPr

e to

Pos

tPr

e to

FU

BAT

4.23

±3.

067.

85 ±

5.61

8.69

±5.

341.

21.

5SU

DS

62.2

1 ±

21.2

50.6

4 ±

27.8

43.2

1 ±

26.8

0.6

0.9

SPQ

25.3

9 ±

5.84

23.8

5 ±

5.32

22.2

3 ±

6.49

0.3

0.5

FQ m

ain

7.38

±7.

386.

31 ±

1.89

5.69

±2.

361.

11.

8FQ

glo

bal

5.92

±1.

265.

08 ±

2.18

4.31

±1.

890.

71.

3PT

pro

blem

6.46

±1.

895.

15 ±

2.04

4.54

±2.

260.

71.

0PT

tot

al26

.92

±4.

0320

.85

±9.

3119

.23

±8.

621.

51.

9W

ARS

tot

al11

.08

±4.

929.

23 ±

8.39

7.23

±6.

940.

40.

8O

utco

me

mea

sure

s fo

r w

aiti

ng li

st g

roup

for

pre-

trea

tmen

t, p

ost-

trea

tmen

t an

d fo

llow

-up

asse

ssm

ents

(mea

n ±

SD)

and

ESPr

ePo

stFU

ESPr

e to

Pos

tPr

e to

FU

BAT

6.38

±3.

486.

92 ±

3.84

8.69

±6.

370.

20.

7SU

DS

68.2

1 ±

19.3

67.0

8 ±

23.8

61.6

4 ±

23.6

0.1

0.3

SPQ

25.3

1 ±

2.29

24.0

0 ±

3.63

23.3

8 ±

4.53

0.6

0.8

FQ m

ain

7.31

±0.

957.

00 ±

1.08

7.08

±0.

950.

30.

2FQ

glo

bal

4.38

±1.

615.

00 ±

1.87

4.77

±1.

74–0

.4–0

.2PT

pro

blem

4.69

±1.

974.

54 ±

1.51

4.08

±2.

250.

10.

3PT

tot

al26

.38

±5.

9223

.62

±6.

9121

.00

±7.

830.

50.

9W

ARS

tot

al9.

69 ±

8.19

8.15

±5.

966.

92 ±

6.06

0.2

0.3

TCS

scor

es w

ere

high

er fo

r th

e LG

E gr

oup

than

the

CAV

E gr

oup,

alth

ough

bot

htr

eatm

ents

wer

e ra

ted

as c

redi

ble

[Com

mer

cial

-in-c

onfid

ence

info

rmat

ion

has

been

rem

oved

.]C

ESD

P, C

ente

r fo

r Ep

idem

iolo

gic

Stud

ies

Dep

ress

ion

Scal

e; C

oNeg

, com

posit

e in

dex

for

nega

tive

situa

tions

; CoP

os, c

ompo

site

inde

x fo

r po

sitiv

e sit

uatio

ns; d

f, de

gree

s of

free

dom

;FU

, fol

low

-up.

Appendix 6

126 TA

BLE

32

Resu

lts o

f rep

orte

d ou

tcom

es (

psyc

holo

gica

l sym

ptom

s an

d in

terp

erso

nal a

nd s

ocia

l fun

ctio

ning

): no

n-RC

Ts

Stud

yR

esul

tsO

ther

out

com

e in

form

atio

n

Dep

ress

ion/

anxi

ety

stud

ies:

incl

uded

pac

kage

s

cont

inue

d

Cav

anag

h,un

publ

ished

spon

sor

subm

issio

n,20

0484

CO

RE-

OM

(ov

eral

l CO

RE-

OM

item

mea

n) fo

r co

mpl

eter

sam

ple,

n=

104

Mea

n95

%CT

Inta

ke s

ever

itya

1.89

(1.7

7 to

2.0

1)Po

st-t

reat

men

t1.

28(1

.15

to 1

.42)

a84

% w

ere

over

the

clin

ical

cut

-off

poin

t. Pr

e–po

st a

naly

sis d

rop

in o

vera

ll C

ORE

-OM

item

mea

n sc

ore

of 0

.61

poin

ts (t

103

= 9

.38,

p<

0.0

01, E

S =

0.9

5), a

naly

sis o

f onl

y th

ose

over

the

clin

ical

cut

-off

at in

take

had

an

ES o

f1.

17. A

t 6-

mon

th fo

llow

-up

(n=

40)

sig

nific

ant

drop

in s

core

s fr

om p

retr

eatm

ent

of 0

.65

poin

ts (t

49=

6.1

5, p

<0.

001,

ES

1.04

)

WSA

for

com

plet

er s

ampl

e, n

= 1

04

Mea

n95

% C

I

Inta

ke s

ever

ity23

.14

(21.

30 t

o 24

.97)

Post

-tre

atm

ent

18.5

1(1

6.69

to

20.3

2)

Sign

ifica

nt d

rop

in W

SA m

ean

item

sco

re o

f 4.6

3 po

ints

(t10

3=

5.5

3, p

< 0

.001

, ES

= 0

.52)

.A

t 6-

mon

th fo

llow

-up

(n =

34)

, a d

rop

of 8

.86

poin

ts fr

om p

retr

eatm

ent

(t33

= 4

.69,

p<

0.0

01, E

S =

0.8

6).

Self-

repo

rted

mea

sure

s of

anx

iety

and

depr

essio

n: s

igni

fican

t dr

op in

sel

f-re

port

edde

pres

sion

betw

een

sess

ions

1 a

nd 8

of t

hepr

ogra

mm

e of

1.8

5 (t

103

= 8

.50,

p<

0.0

01,

ES =

0.8

2) a

nd in

sel

f-re

port

ed a

nxie

ty o

f1.

83 (t

103

= 1

0.02

, p<

0.0

01, E

S =

0.8

9)

Mar

ks, 2

00389

Self-

rate

d ou

tcom

es fo

r C

ope

(mea

n ±

SD)

nPr

ePo

stD

iffer

ence

(95

% C

I)Im

prov

emen

t (%

)ES

Cope

(n

= 3

9)BD

I23

27.4

±9

16.2

±7.

111

.2**

* (6

.9 t

o 15

.5)

37.7

(29.

4)1.

2H

RSD

3016

.8 ±

5.2

13.3

±6.

23.

5*

(0.9

to

6.1)

15.2

(41.

9)0.

7W

SA38

24.0

±8.

216

.4 ±

8.8

7.6*

** (4

.6 t

o 10

.6)

20.4

(31.

1)0.

9

Sign

ifica

nt m

ean

diffe

renc

e at

***

p <

0.0

01, *

p<

0.0

5. E

S fo

rmul

a: (p

retr

eatm

ent

mea

n po

st-t

reat

men

tm

ean)

/pre

trea

tmen

t SD

.


127


TA

BLE

32

Resu

lts o

f rep

orte

d ou

tcom

es (

psyc

holo

gica

l sym

ptom

s an

d in

terp

erso

nal a

nd s

ocia

l fun

ctio

ning

): no

n-RC

Ts (

cont

’d)

Stud

yR

esul

tsO

ther

out

com

e in

form

atio

n

cont

inue

d

Osg

ood-

Hyn

es,

1998

91H

AM

-D s

core

s (t

wo-

taile

d de

pend

ent

sam

ple

t-te

st)

(mea

n ±

SD)

nBa

selin

eW

eek

12p

Resp

onde

rs

ITT

4118

.9 ±

6.0

11.1

±8.

20.

001

20 (4

9%)

Com

plet

ers

2818

.3 ±

4.6

8.8

±7.

60.

001

18 (6

4%)

PG

I sc

ores

nW

eek

12Re

spon

ders

ITT

412.

5 ±

1.3

19 (4

6%)

Com

plet

ers

282.

1 ±

1.2

18 (6

4%)

PGI r

espo

nder

s ha

d a

scor

e of

1 (v

ery

muc

h im

prov

ed) o

r 2

(muc

h im

prov

ed) b

y w

eek

12.

WSA

sco

res

nBa

selin

eW

eek

12Ch

ange

t-Tes

tdf

p

Tota

l sco

re41

19.0

±7.

910

.9 ±

9.1

8.1

±8.

26.

2740

<0.

001

WSA

sco

res

impr

oved

sig

nific

antly

in e

ach

of t

he fi

ve d

omai

ns (w

ork,

hom

e, s

ocia

l lei

sure

, priv

ate

leisu

re, f

amily

) at

12 w

eeks

from

bas

elin

e.

Sign

ifica

ntly

mor

e U

S pa

tient

s th

an U

Kpa

tient

s co

mpl

eted

the

stu

dy (

p<

0.0

2). U

Spa

tient

s im

prov

ed m

ore.

Mos

t ca

lls (6

8%)

wer

e m

ade

outs

ide

usua

l offi

ce h

ours

.Pa

tient

s w

ho m

ade

the

mos

t C

ope

calls

impr

oved

the

mos

t

Whi

tfiel

d,un

publ

ished

spon

sor

subm

issio

n,20

0493

BD

I-II

, BA

I, B

HS

and

SASS

out

com

es a

t ba

selin

e an

d af

ter

sixt

h se

ssio

n (m

ean

±SD

)

naBa

selin

eSi

xth

sess

ion

t (d

f)p

95%

CI

BDI-I

I 15

30.0

0 ±

11.1

318

.93

±10

.23

6.96

(14)

0.00

0(7

.66

to 1

4,48

)BD

I-II

2028

.15

±11

.41

20.0

0 ±

10.4

14.

91 (1

9)0.

000

(1.6

3 to

6.5

7)BA

I15

21.4

0 ±

11.6

713

.73

±7.

122.

64 (1

4)0.

019

(1.4

3 to

13,

90)

BAI

2020

.30

±11

.23

14.5

5 ±

7.82

2.51

(19)

0.02

1(0

.96

to 1

0.54

)BH

S15

10.1

3 ±

5.30

7.20

±3.

102.

05 (1

4)0.

059

(–0.

13 t

o 6.

00)

BHS

209.

25 ±

5.51

7.05

±3.

792.

00 (1

9)0.

060

(–0.

11 t

o 4.

51)

SASS

1531

.93

±9.

0235

.87

±6.

71–1

.82

(14)

0.09

0(–

8.56

to

0.69

)SA

SS20

32.7

0 ±

8.64

35.6

5 ±

6.79

–1.7

9 (1

9)0.

90(–

6.40

to

0.50

)a

Whe

re n

= 2

0, t

he la

st k

now

n ob

serv

atio

ns w

ere

carr

ied

forw

ard

to a

pply

to

late

r po

ints

whe

re t

he la

ter

scor

esar

e m

issin

g.

Subj

ectiv

e kn

owle

dge

on a

ll fiv

e ite

ms

rega

rdin

g de

pres

sion

impr

oved

sig

nific

antly

from

bas

elin

e at

ses

sion

6. R

esul

ts a

t 3-

mon

thfo

llow

-up

show

sig

nific

ant

redu

ctio

ns fr

omba

selin

e on

all

mea

sure

s ap

art

from

SA

SS.

How

ever

, by

this

asse

ssm

ent

mos

t pa

tient

sw

ere

enga

ged

in o

ne-t

o-on

e ps

ycho

logi

cal

inte

rven

tion

Appendix 6

128 TA

BLE

32

Resu

lts o

f rep

orte

d ou

tcom

es (

psyc

holo

gica

l sym

ptom

s an

d in

terp

erso

nal a

nd s

ocia

l fun

ctio

ning

): no

n-RC

Ts (

cont

’d)

Stud

yR

esul

tsO

ther

out

com

e in

form

atio

n

Dep

ress

ion/

anxi

ety

stud

ies:

oth

ers

cont

inue

d

Yate

s,un

publ

ished

,19

9610

0

HA

DS

Anx

iety

, HA

DS

Dep

ress

ion,

GH

Q a

nd C

RI

subs

cale

res

ults

(m

ean

±SD

)

Bala

nce

WLC

HAD

S An

xiet

yBa

selin

e13

.6 ±

3.8

14.4

±3.

3Po

st-t

reat

men

t11

.2 ±

3.3*

15.6

±4.

0

HAD

S D

epre

ssio

nBa

selin

e8.

5 ±

4.3

10.1

±4.

0Po

st-t

reat

men

t5.

8* ±

2.6*

11.1

±5.

1

GH

QBa

selin

e19

.4 ±

6.6

20.7

±9.

2Po

st-t

reat

men

t14

.0*

±5.

1*23

.0 ±

9.6

CRI b

asel

ine

Logi

cal a

naly

sis9.

7 ±

4.3

9.9

±5.

3 Po

sitiv

e ap

prai

sal

10.0

±4.

310

.1 ±

5.0

Seek

ing

supp

ort

9.7

±3.

59.

3 ±

4.8

Prob

lem

sol

ving

9.4

±4.

59.

3 ±

3.9

Alte

rnat

ive

rew

ards

6.6

±5.

18.

3 ±

4.6

Cog

nitiv

e av

oida

nce

10.2

±4.

110

.2 ±

4.2

Acc

epta

nce

7.9

±5.

09.

3 ±

5.0

CRI p

ost-

trea

tmen

tLo

gica

l ana

lysis

9.5

±4.

510

.4 ±

4.6

Posit

ive

appr

aisa

l11

.8 ±

3.4

8.9

±4.

9Se

ekin

g su

ppor

t8.

4 ±

4.0

9.7

±4.

3Pr

oble

m s

olvi

ng10

.6 ±

3.5

9.2

±4.

8A

ltern

ativ

e re

war

ds8.

8 ±

4.7

7.3

±3.

7C

ogni

tive

avoi

danc

e9.

4 ±

3.9

9.6

±5.

0A

ccep

tanc

e7.

1 ±

4.6

9.9

±5.

7

‡p<

0.0

5 fo

r w

ithin

-gro

up c

ompa

rison

with

bas

elin

e sc

ore.

Ave

rage

leng

th o

f com

pute

r se

ssio

n w

as

1 ho

ur, m

odal

num

ber

of t

opic

s ch

osen

was

3, 1

2 pa

tient

s ha

d on

e co

mpu

ter

sess

ion

and

eigh

t ha

d tw

o or

mor

e (o

nly

one

pers

on h

adm

ore

than

tw

o se

ssio

ns)


129


TA

BLE

32

Resu

lts o

f rep

orte

d ou

tcom

es (

psyc

holo

gica

l sym

ptom

s an

d in

terp

erso

nal a

nd s

ocia

l fun

ctio

ning

): no

n-RC

Ts (

cont

’d)

Stud

yR

esul

tsO

ther

out

com

e in

form

atio

n

Pho

bia/

pani

c st

udie

s: in

clud

ed p

acka

ges

cont

inue

d

Kenw

right

,20

0185

Rat

ings

for

FQ, W

SA, P

T a

nd m

ain

goal

(m

ean

±SD

)

Pre

Post

p (p

re–p

ost)

FQ t

otal

pho

bia

(0–1

20)

FF35

.9 ±

23.7

27.8

±22

.7<

0.00

01C

linic

ian

42.8

±25

.231

.7 ±

25.9

<0.

001

Mai

n ph

obic

trig

ger (

0–8)

FF6.

7 ±

1.3

4.1

±1.

4<

0.00

01C

linic

ian

6.8

±1.

54.

0 ±

2.2

<0.

0001

Mai

n go

al (

0–8)

FF5.

8 ±

1.4*

2.6

±2.

2<

0.00

01C

linic

ian

7.6

±0.

64.

3 ±

2.7

<0.

0001

FQ g

loba

l pho

bia

(0–8

)FF

5.0

±1.

9*3.

3 ±

2.0

<0.

0001

C

linic

ian

6.0

±1.

03.

8 ±

2.2

<0.

0001

WSA

wor

k (0

–8)

FF4.

0 ±

2.5

2.8

±2.

4<

0.00

01C

linic

ian

4.9

±2.

73.

6 ±

2.9

<0.

005

WSA

hom

e m

anag

emen

t (0

–8)

FF1.

9 ±

2.1

1.1

±1.

8<

0.00

01C

linic

ian

2.9

±2.

71.

7 ±

2.2

<0.

010

WSA

soc

ial l

eisu

re (

0–8)

FF3.

5 ±

2.3*

2.0

±2.

0<

0.00

01C

linic

ian

5.2

±2.

74.

6 ±

6.0

<0.

526

WSA

priv

ate

leisu

re (

0–8)

FF1.

7 ±

1.7*

1.0

±1.

5<

0.00

01C

linic

ian

3.7

±3.

02.

1 ±

2.3

<0.

004

WSA

rela

tions

hips

(0–

8)FF

2.8

±2.

22.

0 ±

2.2

<0.

003

Clin

icia

n3.

6 ±

2.7

2.0

±2.

3<

0.00

3

FQ a

nxie

ty/d

epre

ssio

n (0

–40)

FF21

.9 ±

12.6

14.7

±12

.7<

0.00

01C

linic

ian

20.8

±10

.414

.5 ±

12.5

<0.

0001

*p<

0.0

5 fo

r FF

clin

icia

n gu

ided

.

31 c

linic

ian

patie

nts

spen

t a

mea

n of

444

min

utes

with

the

the

rapi

st o

ver

eigh

t se

ssio

ns

Appendix 6

130 TA

BLE

32

Resu

lts o

f rep

orte

d ou

tcom

es (

psyc

holo

gica

l sym

ptom

s an

d in

terp

erso

nal a

nd s

ocia

l fun

ctio

ning

): no

n-RC

Ts (

cont

’d)

Stud

yR

esul

tsO

ther

out

com

e in

form

atio

n

Kenw

right

,20

0486

Com

pari

son

of o

utco

mes

(m

ean

±SD

)

Pre

Post

FUCh

ange

(%

)ES

0–16

wee

ks

Inte

rnet

FF

grou

p (n

= 1

0)FQ

glo

bal (

0–8)

6.0

±1.

23.

4 ±

1.3

2.8

±1.

753

***

1.5

FQ t

otal

(0–1

20)

46 ±

2732

±24

35 ±

2324

***

0.4

FQ d

epre

ssio

n (0

–8)

4.1

±1.

93.

2 ±

4.0

2.0

±1.

551

**0.

6FQ

anx

iety

/dep

ress

ion

(0–4

8)19

.4 ±

6.6

19 ±

4.8

7 ±

4.1

64**

*1.

8W

SA t

otal

(0–4

0)19

.1 ±

1012

±7.

311

±10

42**

*0.

8

Clin

ic F

F gr

oup

(n=

17)

FQ g

loba

l (0–

8)5.

4 ±

2.0

3.2

±1.

83.

2 ±

1.6

41**

*1.

5FQ

tot

al (0

–120

)49

±27

32 ±

2333

±27

33**

*0.

6FQ

dep

ress

ion

(0–8

)4.

3 ±

2.4

4.3

±7.

12.

9 ±

2.1

33**

0.8

FQ a

nxie

ty/d

epre

ssio

n (0

–48)

25.8

±13

.314

.1 ±

1017

.5 ±

13.3

32**

*0.

6W

SA t

otal

(0–4

0)17

±10

12 ±

10.7

10 ±

1041

*0.

8

***p

< 0

.001

, *p

< 0

.05,

cha

nge

calc

ulat

ed a

s pr

etre

atm

ent

– fo

llow

-up

mea

n/pr

etre

atm

ent

mea

n ×

100;

ES

cal

cula

ted

as p

retr

eatm

ent

mea

n- fo

llow

-up

mea

n/pr

etre

atm

ent

SD.

NR


131


TA

BLE

33

Patie

nt p

refe

renc

es a

nd c

oncl

usio

ns: R

CTs

Stud

yPa

tien

t pr

efer

ence

, sat

isfa

ctio

n an

d ac

cept

abili

ty o

f tre

atm

ent

Con

clus

ions

Dep

ress

ion/

anxi

ety

stud

ies:

incl

uded

pac

kage

s

cont

inue

d

Prou

dfoo

t, 20

0487

Satis

fact

ion

with

tre

atm

ent

stat

ed t

o be

sig

nific

antly

hig

her

amon

g Bt

B pa

tient

s th

anTA

U p

atie

nts,

but

val

ues

NR

BtB

was

ass

ocia

ted

with

impr

ovem

ent

in s

ympt

oms

with

out

inte

ract

ion

with

dru

g tr

eatm

ent,

dura

tion

of p

re-e

xist

ing

illne

ss o

r se

verit

y of

exist

ing

illne

ss. H

owev

er, f

or a

nxie

ty a

nd p

ositi

ve a

ttrib

utio

nal s

tyle

,tr

eatm

ent

inte

ract

ed w

ith s

ever

ity s

o th

at B

tB w

as o

nly

mor

e ef

fect

ive

than

TA

U fo

r m

ore

seve

rely

ill p

atie

nts

Dep

ress

ion/

anxi

ety

stud

ies:

oth

er s

tudi

es

Chr

isten

sen,

200

495Bo

th t

he M

oodG

ym s

ite a

nd t

he p

sych

oedu

catio

nal s

ite w

ere

acce

ptab

le t

opa

rtic

ipan

ts, i

mpl

ied

by lo

w d

ropo

ut r

ates

. No

data

pre

sent

edBo

th M

oodG

ym (C

CBT

) and

Blu

e Pa

ges

(psy

choe

duca

tion)

del

iver

edvi

a th

e In

tern

et w

ere

effe

ctiv

e in

red

ucin

g sy

mpt

oms

of d

epre

ssio

n.H

owev

er, t

his

was

a s

elf-

sele

cted

pop

ulat

ion,

not

nec

essa

rily

clin

ical

lyde

pres

sed

Pho

bia/

pani

c st

udie

s: in

clud

ed p

acka

ges

Mar

ks, 2

00488

Post

-tre

atm

ent

patie

nts’

rat

ing

of t

reat

men

t he

lpfu

lnes

s (r

atin

g sc

ale

0–8)

did

not

diffe

r sig

nific

antly

bet

wee

n gr

oups

, alth

ough

FF

patie

nts

tend

ed t

o be

mor

e sa

tisfie

dth

an r

elax

atio

n pa

tient

s

Both

clin

icia

n an

d FF

gro

ups

impr

oved

on

mos

t m

easu

res

but

both

had

signi

fican

tly m

ore

drop

outs

tha

n re

laxa

tion,

whi

ch w

as n

ot e

ffect

ive

Pho

bia/

pani

c st

udie

s: o

ther

stu

dies

Car

lbrin

g, 2

00192

Mos

t pa

rtic

ipan

ts c

onsid

ered

the

CC

BT t

o be

per

sona

l des

pite

the

lack

of p

erso

nal

cont

act.

The

maj

ority

of p

artic

ipan

ts r

egar

ded

the

lack

of e

ye c

onta

ct h

elpf

ul.

Alm

ost

all p

artic

ipan

ts fo

und

it an

adv

anta

ge t

o re

ceiv

e th

e tr

eatm

ent

at h

ome

and

at a

tim

e of

the

ir ch

oosin

g

Part

icip

ants

in t

he C

CBT

gro

up s

how

ed s

igni

fican

t im

prov

emen

t, bu

tth

ose

in t

he W

LC g

roup

did

not

Car

lbrin

g, 2

00394

Part

icip

ants

foun

d th

e C

CBT

mod

erat

ely

pers

onal

. A n

umbe

r of

par

ticip

ants

felt

‘alo

ne in

cyb

ersp

ace’

and

felt

that

the

y w

ould

hav

e be

nefit

ed fr

om a

foru

m t

odi

scus

s th

e tr

eatm

ent

and

supp

ort

each

oth

er. S

uch

a fo

rum

, the

y fe

lt, w

ould

hav

em

otiv

ated

the

m in

the

pro

gram

me.

The

y fe

lt th

at t

he p

rom

pts

and

dead

lines

help

ed t

o av

oid

proc

rast

inat

ion.

Alm

ost

all m

entio

ned

the

adva

ntag

e of

bei

ng a

ble

to r

ecei

ve t

he t

reat

men

t at

hom

e an

d at

tim

es t

hat

suite

d th

em

CC

BT p

lus

min

imal

the

rapi

st c

onta

ct v

ia e

-mai

l has

a s

igni

fican

t m

ediu

mto

larg

e ef

fect

. App

lied

rela

xatio

n w

as s

omew

hat

mor

e ef

fect

ive

than

CC

BT

Schn

eide

r, 20

0590

Self-

and

ass

esso

r-ra

ted

satis

fact

ion

scal

es d

id n

ot d

iffer

sig

nific

antly

bet

wee

n FF

and

MA

, sat

isfac

tion

with

tre

atm

ent

was

cor

rela

ted

signi

fican

tly p

ositi

vely

with

outc

ome

of t

he m

ain

prob

lem

at

post

-tre

atm

ent

(r =

0.4

7, p

= 0

.001

) and

1-

mon

th fo

llow

-up

(r =

0.4

5, p

= 0

.002

)

Both

FF

and

MA

wer

e eq

ually

effe

ctiv

e po

st-t

reat

men

t, bu

t at

1-m

onth

follo

w-u

p FF

was

sig

nific

antly

mor

e ef

fect

ive

on s

ome

mea

sure

s. N

one

of t

he p

atie

nts

saw

a c

linic

ian

in p

erso

n, a

ll co

mm

unic

atio

n w

ith a

clin

icia

n w

as b

y te

leph

one

Cla

rke,

200

297N

RT

here

was

no

signi

fican

t ef

fect

for

CC

BT a

cros

s th

e en

tire

sam

ple.

The

re w

as a

mod

est

effe

ct a

mon

g pe

ople

rep

ortin

g lo

w le

vels

ofde

pres

sion

at in

take

. The

aut

hors

rep

ort

low

usa

ge r

ates

in t

he C

CBT

grou

p

Appendix 6

132 TA

BLE

33

Patie

nt p

refe

renc

es a

nd c

oncl

usio

ns: R

CTs

(con

t’d)

Stud

yPa

tien

t pr

efer

ence

, sat

isfa

ctio

n an

d ac

cept

abili

ty o

f tre

atm

ent

Con

clus

ions

[Com

mer

cial

-in-c

onfid

ence

info

rmat

ion

has

been

rem

oved

.]A

NO

VA, a

naly

sis o

f var

ianc

e.

Car

lbrin

g, 2

00496

Mos

t pa

rtic

ipan

ts in

bot

h gr

oups

wer

e sa

tisfie

d w

ith t

he t

reat

men

ts. A

lmos

t al

lpa

rtic

ipan

ts fe

lt th

at t

he p

ace

was

too

fast

. Thi

s w

as e

spec

ially

so

in t

he C

CBT

grou

p, w

here

onl

y 28

% o

f the

mod

ules

wer

e fin

ished

in t

ime

CC

BT p

lus

min

imal

the

rapi

st c

onta

ct v

ia e

-mai

l was

equ

ally

effe

ctiv

e as

trad

ition

al C

BT. T

his

was

stil

l tru

e at

1-y

ear

follo

w-u

p

Fras

er, 2

00198

NR

The

re w

as n

o sig

nific

ant

diffe

renc

e be

twee

n th

e th

ree-

and

six

-ses

sion

grou

ps. B

oth

grou

ps im

prov

ed a

cros

s m

ost

outc

ome

mea

sure

s fr

ompr

e- t

o po

st-t

reat

men

t an

d fo

llow

-up.

The

stu

dy d

esig

n w

as fl

awed

inth

at d

ropo

uts

wer

e re

plac

ed

Gilr

oy, 2

000,

107

Gilr

oy,2

00399

The

re w

as a

sig

nific

ant

diffe

renc

e in

acc

epta

nce

and

perc

eive

d he

lpfu

lnes

s be

twee

nth

e liv

e ex

posu

re a

nd t

he r

elax

atio

n gr

oup

(p<

0.0

01),

with

live

exp

osur

e ra

ted

mor

e ac

cept

able

and

hel

pful

All

trea

tmen

t gr

oups

sho

wed

a s

igni

fican

t im

prov

emen

t fr

om b

asel

ine,

mai

ntai

ned

at 3

3-m

onth

follo

w-u

p

Hea

ding

, 200

1101

AN

OVA

foun

d th

at t

he L

GE

grou

p sc

ored

sig

nific

antly

hig

her

than

the

CAV

E gr

oup

for

TH

and

TA

The

re w

ere

no s

igni

fican

t di

ffere

nces

bet

wee

n th

e C

AVE

and

the

WLC

grou

ps, w

ith t

he e

xcep

tion

of s

ubje

ctiv

e un

its o

f dist

ress

. LG

E w

assu

perio

r to

bot

h C

AVE

and

WLC


133


TA

BLE

34

Patie

nt p

refe

renc

es a

nd c

oncl

usio

ns: n

on-R

CTs

Stud

yPa

tien

t pr

efer

ence

, sat

isfa

ctio

n an

d ac

cept

abili

ty o

f tre

atm

ent

Con

clus

ions

Dep

ress

ion/

anxi

ety

stud

ies:

incl

uded

pac

kage

s

Cav

anag

h, u

npub

lishe

dsp

onso

r su

bmiss

ion,

2004

84

No

info

rmat

ion

repo

rted

. How

ever

App

endi

x 6

of t

he s

pons

or s

ubm

issio

n st

ated

that

of 2

19 p

artic

ipan

ts, 8

4 (3

8.4%

) gav

e fe

edba

ck a

nd s

tate

d th

at t

heir

trea

tmen

tw

as a

pos

itive

exp

erie

nce.

No

info

rmat

ion

was

pro

vide

d fo

r 61

par

ticip

ants

(45%

)w

ho c

ompl

eted

eig

ht s

essio

ns

Non

-com

para

tive

tria

l, tw

o ou

tcom

e m

easu

res

only,

sig

nific

ant

impr

ovem

ent

on b

oth

the

CO

RE-O

M a

nd W

SA. H

owev

er, o

nly

84%

of

patie

nts

wer

e w

ithin

the

clin

ical

ran

ge o

n th

e C

ORE

-OM

sca

le. O

nly

18%

of s

ampl

e av

aila

ble

for

6-m

onth

follo

w-u

p, b

ut b

enef

its w

ere

mai

ntai

ned

Dep

ress

ion/

anxi

ety

stud

ies:

oth

er s

tudi

es

Yate

s, u

npub

lishe

d,19

9610

0O

vera

ll re

spon

se t

o th

e pr

ogra

mm

e w

as p

ositi

ve; 2

5 of

29

resp

onde

rs (r

espo

nse

afte

r ea

ch s

essio

n) (8

6.2%

) sai

d th

at t

he p

rogr

amm

e m

ade

them

thi

nk in

a n

eww

ay a

bout

the

ir pr

oble

m. A

fter

the

first

ses

sion

60%

sai

d th

at t

hey

wou

ld p

refe

rdo

ing

the

prog

ram

me

on t

heir

own

as o

ppos

ed t

o w

ith a

the

rapi

st. T

hree

peo

ple

note

d th

at t

he p

rogr

amm

e w

as a

litt

le s

low

Thi

s pr

ogra

mm

e ha

d on

ly a

sin

gle

sess

ion,

with

the

opt

ion

for

mor

ese

ssio

ns if

des

ired.

The

re w

as a

sig

nific

ant

redu

ctio

n in

HA

DS

anxi

ety

and

depr

essio

n sc

ores

and

GH

Q s

core

s fr

om b

asel

ine,

but

no

signi

fican

tim

prov

emen

t in

CRI

sco

res

Pho

bia/

pani

c st

udie

s: in

clud

ed p

acka

ges

Kenw

right

, 200

185N

RBe

fore

tre

atm

ent

FF c

ases

wer

e le

ss s

ever

e th

an c

linic

ian

grou

p; b

oth

grou

ps im

prov

ed b

ut F

F gr

oup

spen

t 86

% le

ss t

ime

with

a c

linic

ian

than

the

clin

icia

n gr

oup;

larg

e dr

opou

t ra

te fo

r bo

th g

roup

s so

follo

w-u

p da

tam

issin

g

Kenw

right

, 200

486In

tern

et u

sers

wer

e sa

id t

o be

gen

eral

ly s

atisf

ied,

alth

ough

no

data

wer

e re

port

ed.

Thr

ee o

f the

ten

Inte

rnet

use

rs s

aid

that

the

y w

ould

hav

e pr

efer

red

face

-to-

face

guid

ed s

elf-

help

to

Inte

rnet

-gui

ded

self-

help

Smal

l stu

dy c

ompa

ring

two

met

hods

of d

eliv

erin

g FF

; pat

ient

s ch

ose

thei

r gr

oups

. Bot

h gr

oups

impr

oved

sig

nific

antly

on

all m

easu

res

Mar

ks, 2

00389

From

the

tot

al s

ampl

e, 7

0 pa

tient

s ga

ve in

form

atio

n on

four

que

stio

ns o

nsa

tisfa

ctio

n (r

ated

0–8

, with

0 b

eing

ver

y go

od a

nd 8

ver

y po

or):

tech

nica

l asp

ects

of t

heir

syst

em: g

ood

to m

oder

ate

(mea

n ±

SD 3

.1 ±

1.5)

;co

nten

t an

d st

ruct

ure:

goo

d to

mod

erat

e (2

.7 ±

1.4)

; liv

e su

ppor

t fr

om c

linic

ian

very

goo

d to

goo

d (1

.6 ±

1.5)

; clin

ic a

s a

who

le g

ood

(2 ±

1.5)

Patie

nts

wer

e m

ost

satis

fied

with

the

ir liv

e su

ppor

t an

d th

e cl

inic

.Ba

lanc

e us

ers

did

not

achi

eve

a cl

inic

ally

mea

ning

ful e

ffect

siz

e on

any

mea

sure

, whe

reas

Cop

e us

ers

did

on m

ost

mea

sure

s. H

owev

er, b

oth

Cop

e an

d Ba

lanc

e us

ers

had

signi

fican

t im

prov

emen

t po

st-t

reat

men

t on

all m

easu

res

Osg

ood-

Hyn

es,

1998

91A

pat

ient

sat

isfac

tion

scal

e w

as fi

lled

out

by t

he 2

8 co

mpl

eter

s. O

vera

ll, p

atie

nts

felt

com

fort

able

with

the

sys

tem

, fou

nd it

eas

y to

use

and

foun

d th

e bo

okle

ts h

elpf

ul.

21 (7

5%) o

f the

28

felt

that

Cop

e ha

d im

prov

ed t

he q

ualit

y of

the

ir liv

es

The

re w

as a

sig

nific

ant

impr

ovem

ent

in p

atie

nts

usin

g th

e C

ope

syst

em,

alth

ough

the

re w

as n

o co

mpa

rison

gro

up. 6

8% o

f cal

ls w

ere

mad

eou

tsid

e of

fice

hour

s

Whi

tfiel

d, u

npub

lishe

dsp

onso

r su

bmiss

ion,

2004

93

At

6 w

eeks

, 60%

rat

ed t

he t

reat

men

t us

eful

as

‘a lo

t’ an

d 40

% ‘a

litt

le’.

33%

rat

edth

eir

over

all e

xper

ienc

e of

usin

g th

e pr

ogra

mm

e as

‘ver

y go

od’ a

nd 6

7% r

ated

it a

s‘g

ood’

. All

15 r

espo

nden

ts s

aid

that

the

y w

ould

rec

omm

end

the

prog

ram

me

toot

hers

. At

the

end

of t

reat

men

t 80

% s

aid

that

the

y w

ould

pre

fer

a C

D-R

OM

ove

rbo

ok t

reat

men

t

Onl

y 22

of 8

0 pa

tient

s on

a w

aitin

g lis

t w

ho w

ere

appr

oach

ed a

gree

d to

part

icip

ate.

Mor

e fe

mal

es t

han

mal

es d

id n

ot a

tten

d sc

reen

ing.

Val

ues

for

3-m

onth

follo

w-u

p w

ere

also

rep

orte

d, b

ut m

any

patie

nts

had

alre

ady

star

ted

ther

apy

with

a t

hera

pist

. The

aut

hors

rep

ort

a sig

nific

ant

incr

ease

in m

ean

BDI-I

I sco

res

betw

een

scre

enin

g an

d th

e fir

st s

essio

n.Pa

tient

s sh

owed

impr

ovem

ent

from

bas

elin

e


135


Appendix 7

OCD studies

Appendix 7

136 TA

BLE

35

Stud

ies

incl

uded

in t

he re

view

Stud

y Fu

ndin

gC

CB

T c

ompo

nent

s (p

acka

ge)

Stud

y ty

pePa

tien

t po

pula

tion

Gre

ist, 2

00211

5Pf

izer

, Inc

., an

d H

ealth

care

Tec

hnol

ogy

Syst

ems

BT S

teps

RC

TO

CD

pat

ient

s

Kenw

right

, 200

5116

Hea

lthca

re T

echn

olog

y Sy

stem

sBT

Ste

psRC

T (s

ched

uled

sup

port

vs

OC

D p

atie

nts

on-d

eman

d su

ppor

t)(m

oder

atel

y se

vere

)

Gre

ist, 1

99811

7Pa

rtia

l fun

ding

from

Pfiz

er, I

nc.

BT S

teps

Ope

n st

udy,

no

com

para

tor

OC

D p

atie

nts

Bach

ofen

, 199

9118

Part

ial f

undi

ng fr

om P

fizer

, Inc

., Sw

iss N

atio

nal S

cien

ce

BT S

teps

Ope

n st

udy,

no

com

para

tor

OC

D p

atie

nts

Foun

datio

n, Ja

pane

se M

inist

ry o

f Edu

catio

n,

Dai

wa

Ang

lo-J

apan

ese

Foun

datio

n, P

usan

Nat

iona

l Uni

vers

ity

TA

BLE

36

Stud

y ch

arac

teris

tics:

RCT

s

Stud

yD

escr

ipti

on o

f CC

BT

Stud

y qu

alit

yC

o-th

erap

y or

med

icat

ion

Com

para

tor

Sam

ple

size

Gre

ist, 2

00211

5BT

Ste

psM

etho

d of

ran

dom

isatio

n N

R;no

blin

ded

asse

ssm

ent;

nopo

wer

cal

cula

tion;

loss

to

follo

w-u

p re

ason

s N

R

51%

had

not

tak

en a

n SR

I for

at le

ast

2 w

eeks

bef

ore

pres

cree

ning

(6 w

eeks

bef

ore

if ta

king

fluo

xetin

e). T

here

mai

nder

wer

e ta

king

an

SRI

at o

r ab

ove

an a

dequ

ate

min

imum

sta

ble

dose

(e.g

. 20

mg

per

day

fluox

etin

e, 5

0 m

gpe

r da

y se

rtra

line)

and

had

been

doi

ng s

o fo

r >

3 m

onth

sbe

fore

pre

scre

enin

g

1. T

hera

py d

eliv

ered

by

beha

viou

r th

erap

ist

2. S

yste

mat

ic r

elax

atio

n gu

ided

by a

n au

diot

ape

and

a m

anua

l(c

ontr

ol)

BT S

teps

n =

74;

beh

avio

urth

erap

ist w

ith c

linic

ian

n =

69;

rela

xatio

n gr

oup

(con

trol

) n

= 7

5To

tal n

= 2

18 r

ando

mise

d,

183

bega

n tr

eatm

ent,

176

had

at le

ast

one

eval

uabl

e vi

sit

Kenw

right

,20

0511

6BT

Ste

ps

Met

hod

of r

ando

misa

tion:

tabl

e of

ran

dom

num

bers

and

opaq

ue e

nvel

opes

; no

blin

ded

asse

ssm

ent;

no p

ower

calc

ulat

ion;

loss

to

follo

w-u

pre

ason

s N

R

22 (5

0%) w

ere

on a

sta

ble

adeq

uate

or

grea

ter

dose

of a

nSR

I and

had

bee

n so

for

>3

mon

ths

befo

re s

cree

ning

BT S

teps

in b

oth

arm

s, o

new

ith s

ched

uled

hel

plin

esu

ppor

t an

d th

e ot

her

with

on

-dem

and

help

line

supp

ort

48 p

atie

nts

refe

rred

, of w

hom

four

wer

e un

suita

ble,

ther

efor

e 44

ran

dom

ised:

sche

dule

d he

lplin

e su

ppor

t n

= 2

2; o

n-de

man

d he

lplin

esu

ppor

t n

= 2

2, e

ight

dro

pped

out

befo

re s

elf-

asse

ssm

ent


137


TA

BLE

37

Stud

y ch

arac

teris

tics:

non

-RCT

s

Stud

yD

escr

ipti

on o

f CC

BT

Stud

y qu

alit

yC

o-th

erap

y or

med

icat

ion

Com

para

tor

Sam

ple

size

Gre

ist, 1

99811

7BT

Ste

psN

o co

mpa

rato

r an

d no

men

tion

of a

lloca

tion

to B

TSt

eps;

no

blin

ded

asse

ssm

ent;

no p

ower

cal

cula

tion;

loss

to

follo

w-u

p N

R; n

o m

entio

n of

prog

nost

ic fa

ctor

s an

d no

adju

stm

ent

for

conf

ound

ers;

som

e co

mpa

rison

s w

ere

mad

ere

gard

ing

num

ber

ofco

mpl

eted

ses

sions

20 s

ubje

cts

wer

e on

psyc

hotr

opic

med

icat

ion,

on

ast

able

dos

e fo

r ≥

3 m

onth

s an

dag

reed

not

to

chan

ge it

whi

lew

orki

ng t

hrou

gh B

T S

teps

Non

en

= 4

0 (B

osto

n n

= 1

2,Lo

ndon

n =

15,

M

adiso

n n

= 1

3)

Bach

ofen

,19

9911

8BT

Ste

psN

o co

mpa

rato

r an

d no

men

tion

of a

lloca

tion

to B

TSt

eps;

no

blin

ded

asse

ssm

ent;

no p

ower

cal

cula

tion;

loss

to

follo

w-u

p N

R; n

o m

entio

n of

prog

nost

ic fa

ctor

s; n

o m

entio

nof

adj

ustm

ent

for

conf

ound

ers

NR

Non

eO

rigin

ally

n =

23,

but

tw

o le

ftea

rly fo

r cl

inic

ian-

led

ther

apy

whe

n th

eir

turn

on

the

wai

ting

list

arriv

ed, l

eavi

ng n

= 2

1

TA

BLE

38

Ther

apy

deta

ils: R

CTs

Stud

yR

ecru

itm

ent

Num

ber

of s

essi

ons

Leng

th o

f ses

sion

sT

hera

pist

con

tact

Pro

fess

iona

l bac

kgro

und

ofth

erap

ist

Gre

ist, 2

00211

5Su

bjec

ts w

ere

recr

uite

d vi

ara

dio,

new

spap

erad

vert

isem

ents

and

art

icle

s,cl

inic

ians

’ cur

rent

cas

eloa

dsan

d re

ferr

als

from

col

leag

ues

1. B

TSt

eps:

nin

e st

eps

(10-

wee

k st

udy

perio

d, p

atie

nts

prog

ress

ed a

t th

eir

own

pace

)2.

Clin

icia

n-gu

ided

the

rapy

: 11

wee

kly

sess

ions

3. R

elax

atio

n: 1

hou

r da

ily o

ver

10-w

eek

perio

d

1. B

T S

teps

: mea

n le

ngth

of

tele

phon

e ca

lls 8

.6 m

inut

es2.

Clin

icia

n-gu

ided

the

rapy

: 1ho

ur (o

r lo

nger

)3.

Rel

axat

ion:

at

leas

t 1

hour

daily

All

part

icip

ants

met

with

acl

inic

ian

for

15 m

inut

es a

tba

selin

e an

d at

the

end

of

wee

ks 2

, 6 a

nd 1

0 af

ter

star

ting

trea

tmen

t

Clin

icia

ns w

ho h

ad b

ehav

iour

ther

apy

expe

rtise

; bac

kgro

und

NR

Kenw

right

,20

0511

6Re

ferr

ed b

y G

Ps o

rps

ychi

atris

ts

17 w

eeks

’ unl

imite

d ac

cess

plus

brie

f liv

e he

lplin

e su

ppor

tdu

ring

offic

e ho

urs

in e

ither

(a) n

ine

ther

apist

-initi

ated

tele

phon

e ca

lls (s

ched

uled

supp

ort)

or

(b) p

atie

nt-

initi

ated

cal

ls w

hen

help

was

wan

ted

(on-

dem

and

supp

ort)

Sess

ion

leng

th n

ot r

epor

ted.

Tele

phon

e tim

e fo

r sc

hedu

led

patie

nts

mea

n 7.

5 ±

3.7

calls

,m

ean

dura

tion

per

patie

nt

13 m

inut

es (r

ange

5–3

5)

On-

dem

and

patie

nts

mea

n 1.

5 ±

2.8

calls

Thr

ee p

atie

nts

wer

e sc

reen

edliv

e, t

he o

ther

45

by t

elep

hone

for

45 m

inut

esSc

hedu

led

patie

nts:

tot

al m

ean

time

per

patie

nt 7

6 ±

78m

inut

esO

n-de

man

d pa

tient

s: m

ean

tota

l sup

port

tim

e pe

r pa

tient

16 ±

36 m

inut

es

NR;

scr

eeni

ng b

y nu

rse

ther

apist

or

psyc

hiat

rist

Appendix 7

138 TA

BLE

39

Ther

apy

deta

ils: n

on-R

CTs

Stud

yR

ecru

itm

ent

Num

ber

of s

essi

ons

Leng

th o

f ses

sion

sT

hera

pist

con

tact

Pro

fess

iona

l bac

kgro

und

ofth

erap

ist

Gre

ist, 1

99811

7C

linic

ians

, pat

ient

enq

uirie

san

d ne

wsp

aper

adv

ertis

emen

tsN

ine

step

s, B

T S

teps

was

to

be u

sed

daily

NR

To c

onfir

m s

ubje

cts’

diso

rder

diag

nosis

mos

t ha

d fa

ce-t

o-fa

ce in

terv

iew

; oth

er c

onta

ctN

R

NR

Bach

ofen

,19

9911

8Pa

tient

s w

ho w

ere

plac

ed o

n a

wai

ting

list

to r

ecei

ve C

BTN

ine

step

s, B

T S

teps

was

to

be u

sed

daily

, sys

tem

was

use

dfo

r a

mea

n of

67.

2 ±

38.3

day

s

NR

5 m

inut

es b

efor

e be

ginn

ing

prog

ram

me.

Tot

al m

ean

cont

act

time

was

99

±50

.6m

inut

es p

er p

atie

nt

NR

TA

BLE

40

Stud

y sit

e, fo

llow

-up

and

incl

usio

n/ex

clus

ion

crite

ria: R

CTs

Stud

ySt

udy

site

Leng

th o

f fol

low

-up

Num

bers

lost

to

Rea

sons

for

loss

to

Incl

usio

n cr

iter

iaEx

clus

ion

crit

eria

follo

w-u

pfo

llow

-up

Gre

ist, 2

00211

5Ei

ght

sites

in U

SA a

ndC

anad

a14

wee

ks a

fter

trea

tmen

tan

d 26

wee

ks a

fter

first

scre

enin

g vi

sit

35 in

tot

al (B

T S

teps

19,

clin

icia

n-gu

ided

gro

up 1

4,re

laxa

tion

9), f

or t

hose

not

havi

ng a

t le

ast

one

eval

uabl

e po

st-w

eek

0vi

sit

NR

OC

D fo

r ≥

2 ye

ars

on t

heSC

ID. S

core

>7

on t

heYB

OC

S co

mpu

lsion

ssu

bsca

le

Past

Tou

rett

e’s

diso

rder

,sc

hizo

phre

nia,

bip

olar

diso

rder

, psy

chos

is,ps

ycho

surg

ery,

cur

rent

co-m

orbi

d pr

imar

y m

ajor

depr

essio

n, s

erio

ussu

icid

al t

houg

hts

orun

stab

le m

edic

alco

nditi

ons;

or

in t

he p

ast

6 m

onth

s, a

lcoh

ol o

rsu

bsta

nce

abus

e or

elec

troc

onvu

lsive

the

rapy

Kenw

right

,20

0511

6En

rolm

ent

via

Mau

dsle

yH

ospi

tal i

n so

uth-

east

Lond

on a

nd a

clin

ic in

wes

t Lo

ndon

, UK

17 w

eeks

Sche

dule

d su

ppor

t gr

oup:

drop

ped

out

befo

re s

elf-

asse

ssm

ent

n =

2,

drop

ped

out

befo

re s

elf-

trea

tmen

t n

= 1

On-

dem

and

supp

ort

grou

p: d

ropp

ed o

utbe

fore

sel

f-as

sess

men

t n

= 6

, dro

pped

out

befo

re s

elf-

trea

tmen

t n

= 7

NR

Prim

ary

OC

D (D

SM-IV

crite

ria) f

or ≥

2 ye

ars;

no

schi

zoph

reni

a, b

ipol

ardi

sord

er o

r ot

her

psyc

hosis

, prim

ary

maj

orde

pres

sion,

sui

cida

l pla

ns,

or a

lcoh

ol o

r su

bsta

nce

abus

e; if

alre

ady

on a

nSR

I, ab

le t

o re

mai

n on

ast

able

dos

e du

ring

the

stud

y

NR


139


TA

BLE

41

Stud

y sit

e, fo

llow

-up

and

incl

usio

n/ex

clus

ion

crite

ria: n

on-R

CTs

Stud

ySt

udy

site

Leng

th o

f fol

low

-up

Num

bers

lost

to

Rea

sons

for

loss

to

Incl

usio

n cr

iter

iaEx

clus

ion

crit

eria

follo

w-u

pfo

llow

-up

Gre

ist, 1

99811

7Bo

ston

, MA

, USA

,M

adiso

n, W

I, U

SA,

Lond

on, U

K

12-w

eek

tria

l fol

low

ed b

y22

-wee

k ex

tens

ion

phas

eFi

ve o

f the

40

did

not

com

plet

e as

sess

men

t, 15

com

plet

ed a

sses

smen

tbu

t pe

rfor

med

no

sess

ions

, thr

ee c

ompl

eted

asse

ssm

ent

and

perf

orm

ed o

ne s

essio

n. A

tota

l of 1

7 (4

2.5%

)co

mpl

eted

ass

essm

ent

and

perf

orm

ed t

wo

orm

ore

sess

ions

NR

YBO

CS

tota

l sco

re ≥

16,

or Y

BOC

S co

mpu

lsion

scor

e ≥

8; n

ot s

ever

ely

depr

esse

d, n

o pl

ans

for

suic

ide,

OC

D h

adpr

eced

ed a

ny c

o-m

orbi

dm

ajor

dep

ress

ion

by

≥1

mon

th, n

o ps

ycho

ticor

sub

stan

ce u

se d

isord

eror

per

sona

lity

diso

rder

to

disr

upt

com

plia

nce

≥10

hou

rs t

hera

py fo

rO

CD

by

ther

apist

,ps

ycho

tic o

r su

bsta

nce

abus

e di

sord

er,

pers

onal

ity d

isord

er o

r≥

14 o

n H

AM

-D

Bach

ofen

,19

9911

8U

KN

RTw

o in

itial

ly, t

hen

two

mor

eTw

o ha

d to

leav

e th

est

udy

early

in t

he fi

rst

3 w

eeks

bec

ause

the

irtu

rn o

n th

e w

aitin

g lis

tto

beg

in c

linic

ian-

guid

ed t

hera

py a

rriv

ed

Dia

gnos

is of

OC

D b

ased

on IC

D-1

0 cr

iteria

, oth

erin

clus

ion

crite

ria N

R

NR

Appendix 7

140 TA

BLE

42

Patie

nt c

hara

cter

istic

s: R

CTs

Stud

yM

etho

ds fo

r A

ge,

Gen

der

Ethn

icit

yEd

ucat

ion/

soci

o-Pa

tien

t hi

stor

yB

asel

ine

diag

nosi

s of

m

ean

±SD

(m

ale/

fem

ale)

econ

omic

bac

kgro

und

com

para

bilit

ydi

sord

er(y

ears

)

Gre

ist, 2

00211

5D

MS-

IV c

riter

ia fo

rO

CD

39 ±

12 (r

ange

15–8

0)58

%/4

2%93

% w

hite

57%

col

lege

deg

ree,

21

% s

ome

colle

geed

ucat

ion,

14%

hig

hsc

hool

dip

lom

a, 6

% le

ssth

an a

hig

h-sc

hool

educ

atio

n

24%

had

a s

econ

dary

diag

nosis

of m

enta

ldi

sord

er: 9

% s

ocia

lph

obia

, 8%

GA

D, 6

%sim

ple

phob

ia, 2

% m

ajor

depr

essio

n, 2

%dy

sthy

mia

. Mea

n H

AM

-Dsc

ore

10 ±

8

NR

Kenw

right

,20

0511

6D

MS-

IV c

riter

ia fo

rpr

imar

y O

CD

40 (S

D N

R)21

/23

NR

45%

une

mpl

oyed

Mea

n O

CD

dur

atio

n w

as16

±13

yea

rs; m

ean

YBO

CS

26 ±

6.2

(ran

ge12

–36)

mea

n H

AM

-D 2

0 ±

9.3.

28 (6

4%) h

ad h

ad p

ast

beha

viou

ral e

xpos

ure

ther

apy

with

ritu

alpr

even

tion

with

abe

havi

our

ther

apist

, and

22 (5

0%) w

ere

on a

stab

le a

dequ

ate

orgr

eate

r do

se o

f an

SRI

and

had

been

so

for

>3

mon

ths

befo

resc

reen

ing

Type

s of

ritu

als

wer

e sim

ilar

for

the

two

grou

ps

TA

BLE

43

Patie

nt c

hara

cter

istic

s: n

on-R

CTs

Stud

yM

etho

ds fo

r A

ge,

Gen

der

Ethn

icit

yEd

ucat

ion/

soci

o-Pa

tien

t hi

stor

yB

asel

ine

diag

nosi

s of

m

ean

±SD

(m

ale/

fem

ale)

econ

omic

bac

kgro

und

com

para

bilit

ydi

sord

er(y

ears

)

Gre

ist, 1

99811

7D

SM-II

I-R c

riter

ia34

.9 ±

8.8

21/1

936

(90%

) whi

te30

% c

ompl

eted

2–4

year

s of

col

lege

NR

NA

Bach

ofen

,19

9911

8IC

D-1

0 cr

iteria

31 ±

8.2

13/1

0N

RN

RM

ean

OC

D d

urat

ion

12.0

±6.

9 ye

ars

NA


141


TA

BLE

44

Out

com

es a

nd a

naly

sis in

form

atio

n: R

CTs

Stud

yO

utco

mes

In

stru

men

ts

Mea

sure

men

t pe

riod

sIT

T a

naly

sis

PGI,

patie

nt g

loba

l im

pres

sion;

CG

I, cl

inic

ian

glob

al im

pres

sion.

Gre

ist, 2

00211

51.

Impr

ovem

ent

in t

he Y

BOC

S sc

ore

2. Im

prov

emen

t by

typ

e of

ritu

al (B

TSt

eps

grou

p on

ly)

3. P

erce

ntag

e of

res

pond

ers

on P

GI

and

CG

I of i

mpr

ovem

ent

4. T

reat

men

t sa

tisfa

ctio

n

YBO

CS,

HA

M-D

, WSA

Base

line

and

post

tre

atm

ent

Yes,

last

rat

ing

carr

ied

forw

ard

for

thos

e w

ho d

ropp

ed o

ut

Kenw

right

,20

0511

6O

CD

rat

ing,

impr

ovem

ent

insy

mpt

oms

YBO

CS,

HA

M-D

at

pret

reat

men

t on

ly,W

SA, p

atie

nt s

atisf

actio

n–5

item

s;sp

ecia

lly d

evise

d, c

ombi

ned

anxi

ety

ratin

g fo

r th

e fir

st t

wo

trea

tmen

tta

rget

s (0

–8 s

cale

)

Pre-

and

pos

t-tr

eatm

ent

NR

TA

BLE

45

Out

com

es a

nd a

naly

sis in

form

atio

n: n

on-R

CTs

Stud

yO

utco

mes

In

stru

men

ts

Mea

sure

men

t pe

riod

sIT

T a

naly

sis

Gre

ist, 1

99811

7Im

prov

emen

t in

OC

D s

ever

ity

YBO

CS,

HA

M-D

, WSA

Pre-

and

pos

t-tr

eatm

ent

and

afte

r 22

-wee

k ex

tens

ion

phas

eN

o

Bach

ofen

,19

9911

8Im

prov

emen

ts in

OC

D s

ympt

oms

YBO

CS,

HA

M-D

, WSA

, PG

IBa

selin

e an

d en

d of

the

stu

dyYe

s

Appendix 7

142 TA

BLE

46

Resu

lts o

f rep

orte

d ou

tcom

es (

psyc

holo

gica

l sym

ptom

s an

d in

terp

erso

nal a

nd s

ocia

l fun

ctio

ning

): RC

Ts

Stud

yR

esul

tsO

ther

out

com

e in

form

atio

n

Gre

ist, 2

00211

5B

asel

ine,

end

-poi

nt a

nd c

hang

e sc

ore

for

YB

OC

S, H

AM

-D a

nd W

SAS

(mea

n ±

SD)

and

% r

espo

nder

sat

end

-poi

nt o

n P

GI

and

CG

I

YBO

CSH

AM-D

Base

line

End-

poin

tCh

ange

aBa

selin

eEn

d-po

int

Chan

geb

BT S

teps

24.6

±4.

319

.0 ±

7.2

5.6

±6.

69.

6 ±

7.9

9.6

±7.

90.

0 ±

6.8

Clin

icia

n25

.2 ±

4.6

17.6

±6.

28.

0 ±

6.6

9.8

±8.

47.

8 ±

7.6

2.0

±9.

4Re

laxa

tion

25.8

±5.

124

.1 ±

6.7

1.7

±4.

89.

7 ±

7.5

10.0

±8.

2–0

.3 ±

7.0

WSA

S to

tal

PGId

CGIe

Base

line

End-

poin

tCh

ange

c

BT S

teps

20.7

±7.

915

.7 ±

8.5

5.0

±7.

238

%38

%C

linic

ian

20.4

±7.

713

.6 ±

8.5

6.8

±8.

358

%60

%Re

laxa

tion

21.8

±7.

619

.8 ±

8.1

2.0

±7.

715

%14

%a

F =

17.

41, p

= 0

.001

; bF

= 1

.53,

p =

0.2

20; c

F =

5.9

4, p

= 0

.003

; d�

2=

24.

36, p

< 0

.001

; e�

2=

28.

26,

p <

0.0

01.

TCBT

gro

up im

prov

ed s

igni

fican

tly m

ore

than

patie

nts

in t

he B

T S

teps

gro

up (t

= 2

.12,

df

= 1

73, p

= 0

.035

). 61

% o

f cal

ls w

ere

mad

e ou

tsid

e bu

sines

s ho

urs

(09.

00–1

7.00

h,M

onda

y to

Frid

ay).

YBO

CS

impr

ovem

ent

corr

elat

ed s

igni

fican

tly w

ith m

ore

calls

(m

ean

+ S

D 2

2.5

+ 7

1.6;

r =

0.2

8,

p =

0.0

4). S

igni

fican

tly g

reat

er lo

ss o

fev

alua

ble

patie

nts

in t

he B

T S

teps

gro

up t

han

in t

he r

elax

atio

n gr

oup

(�2

= 4

.57,

df =

2,

p =

0.0

3)

Kenw

right

,20

0511

6P

re-

and

post

-BT

Ste

ps fo

r Y

BO

CS,

Tri

gger

s (T

reat

men

t Ta

rget

s) a

nd W

SA (

sche

dule

dn =

20,

on

-dem

and

n =

16)

(m

ean

±SD

)

Calls

Pre

Post

Diff

eren

ce (

95%

CI)

ESp

YBO

CS

Sche

dule

d26

.5 ±

5.1

20.2

±9.

26.

3 (4

.6 t

o 11

.6)

1.2

0.00

1To

tal

On-

dem

and

24.5

±5.

922

.4 ±

6.8

2.1

(–1.

8 to

2.4

)0.

30.

36

YBO

CS

Sche

dule

d13

.8 ±

3.0

10.6

±4.

53.

2 (2

.2 t

o 5.

6)1.

00.

001

Obs

essio

nsO

n de

man

d11

.3 ±

5.3

11.0

±4.

10.

3 (–

2.3

to 0

.60)

0.0

0.55

YBO

CS

Sche

dule

d12

.7 ±

2.6

9.6

±4.

93.

1 (2

.2 t

o 6.

1)1.

10.

04C

ompu

lsion

sO

n-de

man

d13

.2 ±

2.9

11.4

±4.

31.

8 (0

.00

to –

2.9)

0.6

0.04

Trig

gers

Sche

dule

d13

.6 ±

1.7

7.7

±4.

05.

9 (5

.0 t

o 8.

7)3.

40.

001

On-

dem

and

13.9

±2.

19.

2 ±

3.9

4.7

(1.3

to

5.5)

2.2

0.00

1

WSA

SSc

hedu

led

25.6

±8.

123

.4 ±

10.6

2.2

(3.9

to

1.9)

0.2

0.06

On-

dem

and

20.3

±9.

921

.1 ±

9.7

–0.8

(–2.

2 to

1.2

)0.

47

ES =

pre

trea

tmen

t m

ean-

post

-tre

atm

ent

mea

n/pr

etre

atm

ent

SD. D

iffer

ence

= p

re-p

ost

diffe

renc

e m

ean.

Sche

dule

d su

ppor

t pa

tient

had

sig

nific

antly

few

er d

ropo

ut; s

igni

fican

tly m

ore

sche

dule

dth

an o

n-de

man

d pa

tient

s re

port

ed d

oing

at

leas

t on

e ho

mew

ork

sess

ion

(95%

vs

57%

;�

2=

17.

31, p

= 0

.000

1)


143


TA

BLE

47

Resu

lts o

f rep

orte

d ou

tcom

es (

psyc

holo

gica

l sym

ptom

s an

d in

terp

erso

nal a

nd s

ocia

l fun

ctio

ning

): no

n-RC

Ts

Stud

yR

esul

tsO

ther

out

com

e in

form

atio

n

Gre

ist, 1

99811

7P

sych

olog

ical

mea

sure

s in

all

pati

ents

(m

ean

±SD

)

Base

line

Wee

k 12

End-

poin

t

Trig

ger

disc

omfo

rt6.

9 ±

1.1

3.7

±2.

5*3.

2 ±

2.4

n24

1824

YBO

CS

23.6

±7.

322

.9 ±

7.6

20.5

±7.

9*n

4030

39YB

for

com

pulsi

on12

.3 ±

3.7

12.0

±3.

610

.4 ±

4.0*

n40

3039

YB fo

r ob

sess

ion

11.3

±4.

410

.9 ±

4.7

10.1

±4.

3*n

4030

39W

SA18

.3 ±

6.8

10.3

±6.

9*11

.4 ±

7.6*

n38

1527

HA

M-D

11.2

±5.

29.

2 ±

4.5

8.6

±4.

1n

3713

21

*p<

0.0

08.

Sim

ilar

resu

lts fo

r th

e 17

BT

Ste

psco

mpl

eter

s (t

hose

who

per

form

ed t

wo

orm

ore

sess

ions

), ex

cept

tha

t th

eir

scor

es o

nYB

OC

S ob

sess

ion

did

not

impr

ove

signi

fican

tly. T

otal

sco

res

impr

oved

signi

fican

tly m

ore

than

am

ong

thos

e pa

tient

sw

ho h

ad o

ne o

r no

ses

sions

(t =

2.9

8,

df =

38,

p =

0.0

05)

Bach

ofen

,19

9911

8P

re-

and

post

-tre

atm

ent

impr

ovem

ent

in Y

BO

CS,

HA

M-D

, WSA

and

PG

I (m

ean

±SD

)

Base

line

Post

Com

plet

ersa

ITTb

tdf

pt

dfp

YBO

CS

tota

l25

±6.

220

±7.

53.

1918

0.00

53.

1220

0.00

5Ri

tual

s13

±3

10 ±

4.4

3.54

180.

002

3.43

200.

003

Obs

essio

ns11

±3.

810

±3.

41.

8918

0.07

41.

8820

0.07

5H

AM

-D22

±8.

117

±8.

32.

9918

0.00

82.

9320

0.00

8W

SA t

otal

20 ±

7.3

17 ±

7.6

2.28

180.

035

2.27

190.

035

PGIc

2.8

±1.

0a

n =

19,

bn

= 2

1, c

n =

8.

Sign

ifica

nt im

prov

emen

t in

the

tot

al g

roup

was

due

sol

ely

to im

prov

emen

t in

the

ten

com

plet

ers

of t

wo

or m

ore

sess

ions

Appendix 7

144 TA

BLE

48

Patie

nt p

refe

renc

es a

nd c

oncl

usio

ns: R

CTs

Stud

yPa

tien

t pr

efer

ence

, sat

isfa

ctio

n an

d ac

cept

abili

ty o

f tre

atm

ent

Con

clus

ions

Gre

ist, 2

00211

5A

t en

d-po

int,

on a

lmos

t ev

ery

item

, pat

ient

s w

ere

mos

t sa

tisfie

d w

ith c

linic

ian-

guid

ed b

ehav

iour

the

rapy

, nex

t m

ost

satis

fied

with

BT

Ste

ps, a

nd le

ast

satis

fied

with

syst

emat

ic r

elax

atio

n. P

atie

nts

who

rec

eive

d cl

inic

ian-

guid

ed b

ehav

iour

the

rapy

or

BT S

teps

wer

e sig

nific

antly

mor

e sa

tisfie

d th

an p

atie

nts

who

rec

eive

d re

laxa

tion,

and

patie

nts

trea

ted

with

clin

icia

n-gu

ided

beh

avio

ur t

hera

py t

ende

d to

be

mor

esa

tisfie

d th

an p

atie

nts

who

use

d BT

Ste

ps

Clin

icia

n-gu

ided

beh

avio

ur t

hera

py w

as s

igni

fican

tly m

ore

effe

ctiv

e th

anBT

Ste

ps, a

lthou

gh b

oth

grou

ps s

how

ed im

prov

emen

t. Bo

th c

linic

ian-

guid

ed b

ehav

iour

the

rapy

and

BT

Ste

ps w

ere

signi

fican

tly m

ore

effe

ctiv

eth

an s

yste

mat

ic r

elax

atio

n, w

hich

was

inef

fect

ive

Kenw

right

, 200

5116

Feel

ing

com

fort

able

in u

sing

BT S

teps

, and

pre

fere

nce

for

BT S

teps

ove

r a

clin

icia

n(s

elf-

rate

d on

0–8

sca

les)

wer

e as

soci

ated

sig

nific

antly

with

a b

ette

r ou

tcom

e on

the

YBO

CS

(t =

2.8

63, p

= 0

.010

, and

t =

3.3

34, p

= 0

.003

, res

pect

ivel

y)

Sche

dule

d su

ppor

t pa

tient

s ha

d sig

nific

antly

few

er d

ropo

uts,

mor

eco

mpl

eter

s of

tw

o or

mor

e ho

mew

ork

sess

ions

and

mor

eim

prov

emen

t on

YBO

CS

tota

l, co

mpu

lsion

s an

d W

SA. T

he a

utho

rspo

int

out

that

the

diff

eren

ce b

etw

een

the

grou

ps is

cau

sed

by a

lack

of

resp

onse

in t

he o

n-de

man

d gr

oup

on t

he Y

BOC

S ob

sess

ion

subs

cale

TA

BLE

49

Patie

nt p

refe

renc

es a

nd c

oncl

usio

ns: n

on-R

CTs

Stud

yPa

tien

t pr

efer

ence

, sat

isfa

ctio

n an

d ac

cept

abili

ty o

f tre

atm

ent

Con

clus

ions

Gre

ist, 1

99811

724

pat

ient

s re

spon

ded

to t

he s

atisf

actio

n qu

estio

nnai

re; 7

1% s

aid

that

BT

Ste

ps h

adim

prov

ed t

he q

ualit

y of

the

ir liv

es. M

ost

repo

rted

litt

le o

r no

disc

omfo

rt o

r an

xiet

ydu

ring

calls

and

indi

cate

d th

at t

he s

yste

m a

llow

ed t

hem

to

expr

ess

thei

r fe

elin

gsw

ell o

r ex

trem

ely

wel

l

An

open

, non

-com

para

tive

tria

l of 4

0 pa

tient

s en

rolle

d in

the

stu

dy; o

nly

17 c

ompl

eted

tw

o or

mor

e se

ssio

ns. T

hese

17

patie

nts

had

signi

fican

tim

prov

emen

t

Bach

ofen

, 199

9118

Not

rep

orte

d; h

owev

er, N

akag

awa

et a

l.119

repo

rt t

hat

afte

r th

e pa

tient

s (n

= 9

)co

mpl

eted

clin

icia

n-gu

ided

car

e (a

fter

BT S

teps

) the

y w

ere

far

mor

e sa

tisfie

d w

ithcl

inic

ian-

guid

ed c

are

than

BT

Ste

ps (m

ean

scor

e 3.

8 ±

1.5

vs 7

.0 ±

0.9;

t =

5.9

, p

< 0

.000

1)

An

open

non

-com

para

tive

tria

l of p

atie

nts

on a

wai

ting

list

for

ther

apy.

Of t

he o

rigin

al 2

3 pa

tient

s, 1

6 (7

6%) w

ent

on t

o co

mpl

ete

self-

asse

ssm

ent

and

this

did

not

redu

ce s

ympt

oms.

Ten

of t

he 2

3 pa

tient

sw

ent

on t

o us

e th

e se

ssio

ns. T

his

grou

p ha

d sig

nific

ant

impr

ovem

ent

insy

mpt

oms


145


See the section ‘Effect sizes’ (p. 17) for calculation of effect sizes and note the statement: that greateremphasis should be placed on the confidence intervals surrounding the treatment effect on the

original scales of measurement.

Appendix 8

Calculated effect sizes

TABLE 50

Study Outcome Treatment n Baseline Post Change Within- Difference Between group treatment group in change group

Mean SD Mean SDES scoresa ESa

Proudfoot, BDI BtB 127 24.9 10.8 12.1 10.3 12.8 1.19 6.50 0.65200487 TAU 114 24.7 9.2 18.4 10.9 6.3 0.68

BAI BtB 123 18.3 10.2 10.9 8.4 7.4 0.73 2.40 0.25TAU 107 19.4 9.3 14.4 10 5 0.54

WSA BtB 130 18.4 9.2 11.2 7.6 7.2 0.78 2.70 0.31TAU 112 19.1 8.3 14.6 8.5 4.5 0.54

Marks, BDI Cope 23 27.4 9.0 16.2 7.1 11.2 1.24200389 HRSD Cope 30 16.8 5.2 13.3 6.2 3.5 0.67

WSA Cope 38 24.0 8.2 16.4 8.8 7.6 0.93

Osgood- HAM-D Cope 41 18.9 6 11.1 8.2 7.8 1.30Hynes, 199891

Marks, Main FF 20 7.4 0.8 3.9 2.0 3.5 4.38 –0.20 –0.22200488 problem TCBT 29 7.3 1.0 3.6 1.3 3.7 3.70

Main FF 20 7.4 0.8 3.9 2.0 3.5 4.38 2.80 3.13problem Relaxation 16 7.1 1.0 6.4 1.4 0.7 0.70

Goals FF 20 7.1 1.1 2.9 1.6 4.2 3.82 0.30 0.26TCBT 29 7.0 1.2 3.1 1.7 3.9 3.25

Goals FF 20 7.1 1.1 2.9 1.6 4.2 3.82 3.80 3.32Relaxation 16 7.1 1.2 6.7 1.6 0.4 0.33

Global FF 20 6.1 1.3 3.8 2.3 2.3 1.77 –1.10 –0.89phobin TCBT 29 6.7 1.2 3.3 1.8 3.4 2.83

FF 20 6.1 1.3 3.8 2.3 2.3 1.77 1.40 1.08Relaxation 16 6.6 1.3 5.7 1.9 0.9 0.69

WSA FF 20 15.5 7.7 10.0 10.5 5.5 0.71 –0.30 –0.04TCBT 29 17.6 8.5 11.8 8.2 5.8 0.68

WSA FF 20 15.5 7.7 10.0 10.5 5.5 0.71 2.00 0.25Relaxation 16 15.4 8.4 11.9 7.7 3.5 0.42

Schneider, Total phobia FF 45 48 34 35 26 13 0.38 –6.00 –0.19200590 MA 23 59 29 40 22 19 0.66

WSA FF 45 23 11 15 10 8 0.73 –1.00 –0.07MA 23 21 20 12 9.1 9 0.45

Kenwright, FQ total FF 54 35.9 23.7 27.8 22.7 8.1 0.34 –3.00 –0.12200185 TCBT 31 42.8 25.2 31.7 25.9 11.1 0.44

Kenwright, FQ total FF Internet 10 46 27 32 24 14 0.52 –3.00 –0.11200486 FF Clinic 17 49 27 32 23 17 0.63

continued

Appendix 8

146

TABLE 50 Continued



Whitfield, BDI Overcoming 20 28.15 11.41 20.00 10.41 8.15 0.71200493 Depression

BAI Overcoming 20 20.30 11.23 14.55 7.82 5.75 0.51Depression

BHS Overcoming 20 9.25 5.51 7.05 3.79 2.20 0.40Depression

SASS Overcoming 20 32.70 8.64 35.65 6.79 2.95 0.34Depression

Carlbring, BSQ CCBT 11 47.5 13.4 35.7 16.2 11.8 0.88 0.50 0.04200394 Relaxation 11 49.2 11.5 37.9 12.8 11.3 0.98

ACQ CCBT 11 33.3 9.8 25.8 8.3 7.5 0.77 2.60 0.30Relaxation 11 32.3 7.1 27.4 8.2 4.9 0.69

Carlbring, BSQ CCBT 25 48.7 11.7 31.8 11.6 16.9 1.44 –4.40 –0.39200496 TCBT 24 52.6 10.8 31.3 9.1 21.3 1.97

ACQ CCBT 25 34.5 8.6 23.8 9.0 10.7 1.24 –0.30 –0.03TCBT 24 34.6 9.3 23.6 7.2 11.0 1.18

Clarke, CESDP ODIN 107 30.7 12.9 23.7 11.9 7.0 0.54 –0.60 –0.05200297 Control 116 31.3 11.5 23.7 14.0 7.6 0.66

Fraser, BAT CCBT 15 4.7 3.7 9.0 5.6 4.3 1.16 –0.50 –0.14200198 three session

CCBT 15 5.6 3.4 10.4 5.2 4.8 –1.41six session

FQ global CCBT 15 5.8 2.0 4.7 2.3 1.1 0.55 0.40 0.20three session

CCBT 15 5.1 2.0 4.4 2.0 0.7 0.35six session

Gilroy, BAT CAVE 15 4.4 2.9 10.9 4.7 6.5 2.24 –5.10 –1.82200399 TCBT 15 3.2 2.7 14.8 3.3 11.6 4.30

BAT CAVE 15 4.4 2.9 10.9 4.7 6.5 2.24 3.50 1.19Relaxation 15 2.7 3 5.7 5.4 3.0 1.00

FQ global CAVE 15 5.8 1.2 3.6 1.6 2.2 1.83 –0.70 –0.42TCBT 15 5.7 2.0 2.8 2.0 2.9 1.45

FQ global CAVE 15 5.8 1.2 3.6 1.6 2.2 1.83 1.40 0.95Relaxation 15 6.1 1.7 5.3 2.1 0.8 0.47

Heading, BAT CAVE 13 4.23 3.06 7.85 5.61 3.62 1.18 –3.45 –1.002001101 one session

TCBT 14 5.62 3.75 12.69 5.84 7.07 1.89one session

BAT CAVE 13 4.23 3.06 7.85 5.61 3.62 1.18 3.08 0.94one session

WLC 13 6.38 3.48 6.92 3.84 0.54 0.16

FQ global CAVE 13 5.92 1.26 5.08 2.18 0.84 0.67 –1.00 –0.62one session

TCBT 14 5.15 1.86 3.31 1.44 1.84 0.99one session

FQ global CAVE 13 5.92 1.26 5.08 2.18 0.84 0.67 1.46 1.01one session

WLC 13 4.38 1.61 5.00 1.87 –0.62 –0.39

continued


147


TABLE 50 Continued



Yates, HADS-A Balance 22 13.6 3.8 11.2 3.3 2.4 0.63 3.60 1.011996100 WLC 23 14.4 3.3 15.6 4.0 –1.2 –0.36

HADS-D Balance 22 8.5 4.3 10.1 4.0 2.7 0.63 3.70 0.89WLC 23 5.8 2.6 11.1 5.1 –1 –0.25

Greist, YBOCS BT Steps 74 24.6 4.3 19.0 7.2 5.6 1.30 –2.00 –0.452002115 TCBT 69 25.2 4.6 17.6 6.2 7.6 1.65

YBOCS BT Steps 74 24.6 4.3 19.0 7.2 5.6 1.30 3.90 0.83Relaxation 75 25.8 5.1 24.1 6.7 1.7 0.33

HAM-D BT Steps 74 9.6 7.9 9.6 7.9 0 0.00 –2.00 –0.25TCBT 69 9.8 8.4 7.8 7.6 2 0.24BT Steps 74 9.6 7.9 9.6 7.9 0 0.00 0.30 0.04Relaxation 75 9.7 7.5 10.0 8.2 –0.3 –0.04

WSA BT Steps 74 20.7 7.9 15.7 8.5 5.0 0.63 –1.80 –0.23TCBT 69 20.4 7.7 13.6 8.5 6.8 0.88

WSA BT Steps 74 20.7 7.9 15.7 8.5 5.0 0.63 3.00 0.39Relaxation 75 21.8 7.6 19.8 8.1 2.0 0.26

Kenwright, YBOCS BT Steps 20 26.5 5.1 20.2 9.2 6.3 1.24 4.2 0.772005116 scheduled

YBOCS BT Steps 16 24.5 5.9 22.4 6.8 2.1 0.36on demand

Greist, YBOCS BT Steps 40 23.6 7.3 22.9 7.6 0.7 0.101998117

Bachofen, YBOCS BT Steps 21 25 6.2 20 7.5 5 0.811999118

a Where comparator groups exist.[Commercial-in-confidence information has been removed.]


149


Appendix 9

Transition matrices

TABLE 51 Transition matrix for treatment as usual

Level Minimal Mild Moderate Severe

Minimal 0.75 0.25 0.00 0.00Mild 0.375 0.417 0.167 0.042Moderate 0.220 0.268 0.439 0.073Severe 0.167 0.083 0.292 0.458

TABLE 52 Transition matrix for Beating the Blues

Level Minimal Mild Moderate Severe

Minimal 1 0.00 0.00 0.00Mild 0.667 0.296 0.037 0.00Moderate 0.361 0.500 0.111 0.028Severe 0.25 0.25 0.25 0.25

SearchThe search aimed to identify all referencesrelating to the use of generic health-related qualityof life instruments [including preference-basedmeasures such as EQ-5D, Health Utility Index(HUI) and SF-6D] and utilities across depression,anxiety and OCD. Population search terms (e.g.depression, anxiety, panic, agoraphobia, phobia,obsessive compulsive disorder) were combined andthe methodological search filters used areprovided in Appendix 4. Searches were conductedin MEDLINE, EMBASE, NHS EED and OHEHEED specifically to identify economic literaturerelating to anxiety and depressive disorders. Thissearch was then complemented by handsearchingof the available literature for utility or outcomedata for depression and the Harvard dataset. Atotal of 63 articles was found in this area.

Inclusion and exclusion criteriaThe systematic review included all preference-basedmeasures and utility values elicited from patients ormembers of the community. Generic health-relatedquality of life measures were included to identifyopportunities for using the SF-6D on the SF-36 orother means of mapping onto preference-basedmeasures. This review does not include symptom-specific questionnaires unless they were usedalongside a generic instrument.

Results of searchAfter careful sifting of the article abstracts, 12articles were found to meet the inclusion criteria(Table 53). Ten studies present health state valuesfor depression, one presents the results of a review,one SF-36 values for anxiety states, one SF-36values on OCD and another is a European surveyof mental health conditions.

ReviewDepressionTen studies were found reporting health stateutility values for depression. These studies used

two valuation techniques, time trade-off (TTC) orstandard gamble (SG). Different methods ofdescribing the condition were used, including thegeneric preference-based measures of EQ-5D andHUI143,144 and bespoke vignettes developed by theresearchers145,146 not suitable for the NICEreference case. Most studies obtained valuesdirectly from patients rather than from membersof the general public,147–150 and so would not besuitable for the reference case. Some wereobtained from clinicians and nurses.144,151 Strictlyspeaking, only one of these studies makes thereference case for the economic model.45

Nonetheless, these studies do provide clearevidence that depression is associated withsignificant decrements in health state utility valuesfor a range of methods and that these decrementsare associated with the severity of the condition. Itis difficult to be sure that these studies are valuingthe same level of depression since studies useddifferent methods for classifying the condition.Unfortunately, none was linked to the BDI, theprimary outcome in the CCBT studies.

While these studies provide important evidence onthe impact of depression, they cannot be useddirectly in the CCBT models. Instead, it wasdecided to use a data set from a recently publishedRCT of supervised self-help CBT in primarycare,54 which incorporated the EQ-5D and Core.This is a suitable source given that the patientswere recruited from 17 primary healthcare teamsand would be broadly representative of the NHS.It used Core rather than the BDI, but Core is adepression-specific questionnaire that is similar inmany ways to the BDI and it has been mappedonto the BDI by the developer of Core (Barkham:personal communication). The mapping functionwas fitted to these data to provide BDI data oneach case.

The Richards study54 provided data on 62 patientswith BDI total scores and EQ-5D data. An initialsimple regression model indicated that therelationship between the BDI score and the EQ-5Dwas not linear, so it was decided simply to estimatemean ± SD scores for three depression categoriesof mild to moderate, moderate to severe andsevere of 0.78 ± 0.20, 0.58 ± 0.31 and 0.38 ±0.32, respectively. As in the trial, there were no


151


Appendix 10

Health state utility values

patients with scores in the minimal category sinceby definition they would not be suitable for thetrial. It was assumed that patients in this minimalcategory would have age- and gender-matchednormal scores for this group of 0.88 ± 0.22.133

These scores are comparable to those obtained inother studies on health state values on similargroups of patients. It is difficult to compare thesevalues with other published studies owing tovariations in methods. Comparisons are onlypossible for those studies that produced values forcomparable severity categories. Bennett151 foundthat mild depression had a mean of 0.59,moderate 0.32 and severe 0.04, and althoughthese are lower they were obtained from cliniciansand nurses. Values published by Revicki145 were0.73 for mild and 0.63 for moderate, but thesewere obtained from patients and were based ondescriptions that included the side-effects oftreatment. Finally, Schaffer149 produced values of0.59, 0.51 and 0.39 for mild, moderate and severedepression, respectively, from patients currentlywith depression. The values for patients inremission varied from 0.86148 to 0.95144,146 and1.0.144 The range produced from the analysis ofthe Richards data set of 0.38 to 0.88 seems to liewithin these estimates.

AnxietyNo published utility values for anxiety states wasfound that was relevant for this report. Studieswere found with SF-36 data, one by Simon andcolleagues152 of a small number of patients andanother from a large European survey, theESEMeD survey.153 These were reviewed to assessthe potential impact of anxiety states on utility.The Simon study showed a significant impact ofanxiety on mental health, social functioning androle emotional dimensions from social anxiety and PD (Table 54).

The ESEMeD study was a large-scale survey ofmental health disorders across six countries inEurope. It was based on psychiatric assessments ofpatients over the past 12 months. It showed asignificant impact on the mental health summaryof the SF-36 across a large number of mentalhealth disorders over the previous 12 months,including specific phobia, social phobia andagoraphobia. The ESEMeD study also collectedEQ-5D and the team led by Alonso agreed toconduct some additional analysis of their data to generate EQ-5D and SF-6D utility values across these states and this is presented in Table 55. It shows significant decrementsassociated with these phobias and that these are

comparable in magnitude to the impact ofphysical medical conditions such as arthritis andheart disease.

A key feature of these patients is that theyrepresent people who were found to have thesemental disorders over the past 12 months. Thesecomprise a mixed group of patients, some ofwhom will be experiencing some degree ofremission, as well as those in the worst phases ofthe condition. How these relate to the patients inthe trial used to populate the economic model isunclear. Furthermore, it is not clear how muchthese specific disorders contributed to thesequality of life scores. If these patients have beencured of their condition it is not clear that theywould have been restored to the value for thosewith no disorder. Nonetheless, they are the bestavailable data in this condition and have beenused in the models presented in this report.

OCDNo published utility values for OCD states werefound that were relevant for this report. Studieswere found with SF-36 data, one by Koran154 of asmall number of patients and one from theEuropean ESEMeD survey.153 These were reviewedto assess the potential impact of anxiety states onutility. Table 56 presents SF-36 scores for OCDpatients compared with normative values154 andthey show a significant impact on the mentalhealth, social functioning, role emotional andvitality dimensions.

The ESEMeD survey included OCD as a state andfound people diagnosed with this condition hadmean EQ-5D scores of 0.72 compared to 0.88 forthose without disorder. This is comparable to thepanic phobia patients. The OCD group includespatients diagnosed as having OCD in the last 12 months.

The ESEMeD survey also collected YBOCS data inthose who complained of obsessive and compulsivesymptoms in the filtering questions (i.e. a questionto determine whether the respondent needs toanswer the full YBOCS). The YBOCS is a self-ratedquestionnaire that asks people about theirobsessive and compulsive symptoms. It generatesscores for these two domains and a total scorebased on a simple summation of them. It was feltthat a better approach would be to use the YBOCSsince this would enable a more direct linkage tothe Greist trial.115

There were 2807 cases who were asked thefiltering questions regarding OCD. Out of these

Appendix 10

152


153


TA

BLE

53

Dep

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heal

th s

tate

val

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yV

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tion

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1995

147

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reat

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tient

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1997

148

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Appendix 10

154 TA

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Resu

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155


TA

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Appendix 10

156

just 21 completed the obsessive scale of theYBOCS and only four completed the compulsivescale. This exclusion of so many cases representsan error in the filtering process; nonetheless, thenumber completing the obsessive scale providedenough to estimate functions to map between thisscale and the preference-based measures. TheESEMeD group undertook the mapping exercisefor this review. They found that a one-pointreduction in the obsessive scale was equivalent to a0.04 reduction in the EQ-5D preference scale(p=0.0006). A similar model for the SF-6Destimated a decrement of 0.03. This algorithm was

applied to the Greist data to convert those whoresponded to the YBOCS to EQ-5D scores.

YBOCS values for non-responders are assumed tobe 25 (i.e. the mean pretreatment score) andresponders to be equivalent to a post-treatmentscore of 16. These scores were converted into EQ-5D scores by applying the mapping functionfrom the obsessive scale to the 0.04 decrement perpoint change in the score. The overall YBOCSscore is composed of the obsessive and compulsivesubscale scores, each contributing half of theoverall score. The Greist study does not report aseparate obsessive subscale score and so it wasassumed that it contributed 50% of the gain. Thisassumption is supported by a finding from theKenwright86 study that reports the two subscales,where an overall change of 6.3 in the schedulesgroup was divided into 3.2 on the obsessive scaleand 3.1 on the compulsions scale. This results inthe values shown in Table 57.

TABLE 57 Mean YBOC scores and mapped EQ scores (withdistributions) for responders and non-responders

YBOCS EQ-5D Distributionscore

Responders 8.125 0.92 (0.07) B (13.81, 1.21)Non-responders 12.5 0.795 (0.15) B (4.96, 1.28)

MethodsThe provision of CCBT results in costs from thefollowing: licence fees, computer hardware,screening of patients for suitability, clinicalsupport, capital overheads (for facilities forcomputer and clinician) and the training of staff.While there are a number of important differencesin the costs of the three products, the basicprinciples of costing are very similar.

Licence feeEach product comes with a licence fee tariff, with allproducts offering a fixed fee for purchase at thelevel of general practice. Cope also offers licences atother organisational levels: PCT, strategic healthauthority, NHD PASA Consortium and country(England, Wales and Scotland). The costs per GPand per patient are substantially less at these higherlevels of purchase. For this costing exercise, it wasdecided to limit the costings to general practice andPCT fee, since it seems unlikely that the NHSwould purchase these products at a higher level.

For Cope and FF the throughput of treatedpatients is assumed in the submission to be 100per copy each year for practices with one to fiveGPs and 200 for those with six to ten GPs. At PCTlevel, it is assumed in the submission that therewill be 2000 patients. For BtB the tariff is bynumber of machines, starting with one and goingup to 50. There is no mention of the level ofpurchase by BtB, but one or two would relate topractice level and 20 or so to PCT or possibly aspecialist centre. Overcoming Depression has tworates, one for the first copy and then a muchreduced rate for subsequent copies. These licencefees seem to be aimed at practices, so it can beassumed that smaller practices would use one copyand larger practices would use two.

ThroughputThe licence fee is fixed, so the cost per patientdepends on the number of patients likely to use eachcopy. The assumption used by BtB, Cope and FF ofa maximum of 100 patients per computer assumesthat around 50% of capacity will be used. Based on30 hours per week, 30 × 50 hours per year (i.e.1500) and allowing for eight sessions plus 15minutes’ introduction for a full course of BtB results

in 187 patients. However, the assumption of 100patients coming forward each year in practices of oneto five GPs is based on the following assumptions: (1) there are 10,000 patients per practice; (2) 1000 ofthese suffer from depression; and (3) 10% of thesewill be treated each year. There is considerableuncertainty surrounding these assumptions.

The assumed list sizes are rather high. Practices withbetween one to five GPs have an average of threeGPs and practices of six to ten have an average ofeight GPs (General Medical Statistics: England andWales, 2002), which results in mean list sizes ofaround 5000 and 14,000, respectively. Theassumption of a 10% prevalence of depression maybe reasonable and is similar to estimates from theONS Morbidity Survey (2000),129 but a majorproblem is that many of these do not come to theattention of a GP.130 It is not clear whether the 10%prevalence figure takes sufficient account of thisproblem, but the proportion of known cases may beas low as 5%. Similar issues are raised with panicphobia and OCD. Finally, the assumption that 10%of these will take up the service is only anassumption and in practice it may be very different.These figures suggest that the numbers of patientsin a one to five practice may be nearer 25–50 (i.e.5000 × 0.05 to 5000 × 0.1) patients treated and forfive to ten practices it may be nearer 40–80 (8000 ×0.05 to 8000 × 0.1) and indeed even lower. Thecostings for Cope and FF presented below are basedon midpoint estimates of 37.5 and 60, respectively,at practice level. The average size of a PCT is165,000, rather than the 200,000 presented, andthis in turn slightly reduces the numbers of patientslikely to be treated to between 825 and 1650(165,000 × 0.05 to 165,000 × 0.01) rather than2000, with a mid-point of 1237.5. For BT Stepsthese figures are further reduced to 20% of thesefigures to allow for the lower prevalence of OCD.

The implications for BtB and OvercomingDepression are that a smaller practice wouldprobably buy one copy and a larger practice twocopies. It has been assessed for the costings thatthey would achieve the same levels of throughputas Cope. They can also be purchased by a PCTand this has been assumed to be equivalent tobuying 20 copies to ensure that all practices wouldhave at least one copy.


157


Appendix 11

Costs of interventions, methods and results

HardwareFor practice-based provision, this is a standarditem. The hardware required to run the softwarewas given in four of the submissions as £700. Toestimate an annual cost it is further assumed thateach computer lasts for 3 years and has beendiscounted at 3.5% (i.e. an annuity factor of2.8997). This gives an annual equivalent cost of£241.41 per machine.

What is less clear is the likely cost per patient,since at the levels of throughput being predictedabove dedicated computers would beunderutilised. A solution to this problem would beto make the computer available for multiple uses,including other CCBT packages. At two extremes,there will be the situation where the machine isperfectly divisible and so can be costed at theassumed rate of 100 patients per machine(whether or not they are depression patients),while the second situation assumes a dedicatedmachine and hence the costs are spread over fewerpatients. For simplicity it is assumed that half ofthe time available on the machine is used foranother purpose, thus reducing the originalcostings by half with ± 20% to allow foruncertainty in the costs of hardware.

The costs of capital overheads have been based onthe value provided in the submission from Nettenand Curtis.136 It covers rental for the space, heat,light and other associated costs of providing thespace necessary in a general practice for a singlemachine. As for hardware, this raises questionsabout the divisibility of the space. The costingshave made the same assumptions as for hardware.

Cope and FF do not require a machine to beavailable in general practice. In the submission themanufacturer claims that patients can access thecomputer program over the Internet at otherlocations, such as at home or in a public library. Inthese cases, it is assumed in the costing that therewill be no hardware cost and associated capitaloverheads.

Clinical supportFor BtB and Overcoming Depression, there will besupport provided by a professional to help thepatients to use the computer program. This hasbeen estimated in BtB to be equivalent to about 1hour of time over the duration of treatment(which can be up to 3 months). The submissionsuggests that this might be provided by thepractice nurse (at £23 per hour), but it could beprovided by either a primary care counsellor (£32per hour) or the much cheaper assistant

psychologist (£8.91). A range has been estimatedassuming all provision by assistants and all byprimary care counsellors. The same level ofsupport has been assumed for OvercomingDepression.

For Cope and FF the manufacturer recommends abrief helpline to support their products. Themanufacturer assumes a total of 1 hour supportper patient over the 3 months of therapy. Usingquite reasonable workload assumptions, theysuggest that each support worker will be able tomanage around 1071 patients each year. Assumingthat the helpline support worker is employed atthe level of a primary mental healthcare workerwith an annual cost of £22,000 p.a. (including on-costs) and this assumed workload, the companyestimates a cost per patient of £21. This costingdoes not allow for overheads (including capital)incurred in a dedicated centre providing such aservice or the qualifications and training of thestaff. For practice nurses these items together addanother 67% to salary costs, according to Nettenand Curtis,136 and an evaluation of NHS Directfound non-staff costs to be at a similar level.142

This level of additional cost suggests an averagebrief helpline support cost per patient of £35.

There will be costs of GP monitoring of patientson CCBT, but these have not been included in thesubmissions. It seems likely that CCBT will occupyat least some GP time. This assumes that any GPcare would have been provided without CCBT andwould have been part of TAU.

There will be an additional element for the timefor the staff involved in training for the use ofCCBT in their practice. This cost has beenannuitised over 3 years. The manufacturers claimthat a varying amount of training is required forthese products, from a full half-day session forBtB, to little or none for the other two products.In the costings BtB incurs costs for this item andcurrently the others do not. For BtB the cost ofstaff time has been based on a half-day session forfive staff trained per machine. The five staffinclude a counsellor, practice nurse, psychologyassistant and two GPs, costed using unit costs fromNetten and Curtis.136 The total staff cost of£229.91 has been combined with a cost of spacefor the training of £6.50. The same figure hasbeen used for Overcoming Depression and Copeto ensure consistency.

ScreeningThe amount of additional time spent assessing thesuitability of the patient for CCBT also varied

Appendix 11

158

between products. A study of OvercomingDepression93 found a 20–30 minute assessment by a psychologist. According to the manufacturer,Cope requires a very short questionnaire to becompleted that takes just 5 minutes or so to assess. Overcoming Depression and BtB havebeen costed assuming 25 minutes of a practicenurse’s or community psychiatric nurse’s time(with a 20–30-minute range). The manufacturers

of Cope claim that screening takes just 5 minutesand this has been used in the costing for thatproduct.

ResultsThe costs of BtB, Cope, Overcoming Depression,FF and BT Steps are shown in Tables 58–62.


159


TABLE 58 Costs of BtB

Expected cost (£) (range)

One copy 20 copies

Licence fee 6000 34000

Hardware (at £700, lasting 3 years, discounted at 3.5%) 120.55 (96.56–144.84) 2411 (1931.2–2896.8)

Capital overheads 800 (640–960) 16000 (12800–19200)

Clinical helper 862.5 (575–1150) 17250 (11500–23000)

Training (costs of time of staff) 81.80 (67.33–91.22) 1636 (1346.6–1824.4)

Screening (taking 25 minutes) 359.25 (239.50–479) 7185 (4790–9580)

Total annual operating costs 8224.1 (7618.39–8825.06) 78482 (66367.80–90501.20)

Total number of treatments available 37.5 (25–50) 750 (500–1000)

Total cost per patient 219.30 (152.37–353.00) 104.62 (66.36–181.00)

TABLE 59 Costs of Cope


Home access 1–5 GP practice PCT: 20 terminals

Licence fee 5000 5000 36000

Hardware (at £700, lasting 3 years, NA 120.55 (96.56–144.84) 2411 (1931.2–2896.80)discounted at 3.5%)

Capital overheads NA 800 (640–960) 16000 (12,800–19,200)

Clinical helper None assumed None assumed

Helpline support 1312.50 (1050–1574.4) 1312.50 (1050–1574.4) 26,250 (21,000–31,488)

Training (costs of time of staff) 81.80 (67.33–91.22) 81.80 (67.33–91.22) 1636 (1346.60–1824.4)

Screening (claimed to take 5 minutes) 29.94 (19.92–39.91) 29.94 (19.92–39.91) 598.80 (398.40–798.20)

Total annual operating costs 6424.24 7344.79 82,895.80 (6137.25–6705.53) (6873.81–7809.97) (73,676.6–92207.40)

Total number of treatments available 37.5 (25–50) 37.5 (25–50) 750 (500–1000)

Total cost per patient 171.30 (122.74–268.22) 195.86 (137.48–312.40) 110.53 (73.68–184.42)

Appendix 11

160

TABLE 61 Costs of FF


Home access 1-5 GP practice PCT: 20 terminals

Licence fee 5000 5000 36,000

Hardware (at £700, lasting NA 120.55 (96.56–144.84) 2411 (1931.2–2896.80)3 years, discounted at 3.5%)

Capital overheads NA 800 (640–960) 16,000 (12,800–19,200)

Clinical helper None assumed None assumed

Helpline support 1312.50 (1050–1574.4) 1312.50 (1050–1574.4) 26,250 (21,000–31,488)


Screening (claimed to takes 29.94 (19.92–39.91)) 29.94 (19.92–39.91) 598.80 (398.40–798.20)5 minutes)

Total annual operating costs 6424.24 7344.79 82895.80 (6137.25–6705.53) (6873.81–7809.97) (73,676.6–92,207.40)

Total number of treatments 37.5 (25–50) 37.5 (25–50) 750 (500–1000)available

Total cost per patient 171.30 (122.74–268.22) 195.86 (137.48–312.40) 110.53 (73.68–184.42)

TABLE 62 Costs of BT Steps


1–5 GP practice: 1–5 GP practice: PCT: 20 terminalshome access practice access

Licence fee 5000 5000 36,000

Hardware (at £700, lasting 3 years, NA 120.55 (96.56–144.84) 2411 (1931.2–2896.80)discounted at 3.5%)

Capital overheads NA 800 (640–960) 16000 (12,800–19,200)

Clinical helper NA NA NA

Helpline support 262.50 (175–350) 262.50 (175–350) 5250 (3500–7000)


Screening (claimed to take 5 minutes) 14.38 (9.6–19.20) 14.38 (9.6–19.20) 287.60 (192–384)

Total annual operating costs 5358.68 6279.23 61,584.60 (5251.93–5460.42) (5988.49–6565.26) (55,769.80–67,305.20)

Total number of treatments available 7.5 (5–10) 7.5 (5–10) 247.5 (165–330)

Total cost per patient 714.49 (525.19–1092.08) 837.23 (598.85–1313.05) 248.83 (169–407.91)

TABLE 60 Costs of Overcoming Depression


One copy Two copies 20 copies purchased by PCT

Licence fee 500 550 8,000

Hardware (at £700, lasting 3 years, 120.55 (96.56–144.84)discounted at 3.5%)

Capital overheads 800 (640–960)

Clinical helper 862.5 (575–1150)

Training (costs of time of staff) 81.80 (67.33–91.22)

Screening (taking 25 minutes) 359.25 (239.50–479)

Total annual operating costs 2724.1 (2118.39–3325.06) 4998.20 (3786–6200) 52482 (40,367.80–56,501.20)

Total number of treatments available 37.5 (25–50) 75 (50–100) 750 (500–1000)

Total cost per patient 72.64 (42.36–133.00) 66.64 (37.86–124) 69.98 (40.37–113)

Beating the BluesTables 63–65 show the input parameters for theeconomic model. The transition from the initialstate to the state post-treatment was found bycalculating the percentage of people in eachcategory immediately post-treatment. Thetransition rate from one category to another,applied in the second cycle of the therapy, wasestimated from the McCrone trial data,120

categorising people pretreatment and calculatingfor each level, how many of those transit from onecategory to another. People enter in a moderatestate of depression in the trial and they haveattached a quality of life correspondingly.

The tables show for each input, the distributionchosen for the PSA and the methods used.Distributions of rates and quality of life for eachcategory are given beta distributions to reflect thatthey are bounded between 0 and 1; costs aremodelled with gamma distributions to allow forthe skewness of these data. The probability ofbeing in each of the four categories is modelledwith a Dirichlet distribution, which is ageneralisation of the Beta distribution when thereare more than two parameters.

Cost of the licence, which is a parameter thatcarries a certain amount of uncertainty, ismodelled with a log-normal distribution. Log-normal distributions are placed around the meancost of each intervention using the ranges as 95%confidence intervals.

The parameters for the Dirichlet distribution aftertreatment were found by counting the number ofpeople in each category immediately post-treatment120 or who transit from one category toanother (second cycle).

CopeThe data on the probability of being in one of thefour states post-therapy were taken from Marks.89

The strategy to extrapolate the proportion of thepatients in each severity level was to place a

normal distribution having as parameters meanand standard deviation of the BDI score post-treatment. The BDI cut-off points for each severity(≤ 9, 10–18, 19–29, 30–63) were used to calculatethe proportions in each category. The cost of thelicence chosen in this model is the one calculatedon a GP practice level. The new data for themodel are shown in Table 66. All other data(including those for TAU) are the same as in BtB.

For the PSA, the probability of being in one of the four states post-therapy was modelled with a Dirichlet distribution. The lower numberswith respect to BtB reflect the fact that thenumber of the participants in the Marks study was only 39, and 23 of them only report data on BDI. The probability of dropping out wascalculated by scaling down the parameters to the actual sample size of the study. Lowerparameters in both the beta and the Dirichletdistribution increase uncertainty in the model. A log-normal distribution was filled to the cost of the licence to reflect the uncertainty in therange and the skewness of this cost. All the other parameters have the same distributions as in BtB.

Table 66 shows the distributions that have beenchanged with respect to the BtB model.

Overcoming DepressionThe data on the probability of being in one of thefour states post-therapy were taken fromWhitfield.93 The transition from the initial state tothe state post-treatment was found by calculatingthe percentage of people in each categoryimmediately post-treatment.

The cost of the licence chosen in this model is theone calculated on a PCT level (Table 60).

The BDI score of the patients in the Whitfieldstudy93 before entering the clinical trial is slightlylower than for Cope and BtB, reflecting a moresevere case of depression. From those data the


161


Appendix 12

Parameter values used in the economic models and their distributions

Appendix 12

162 TA

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0D

ir(13

,18,

4,1)

Tran

sitio

n fr

om m

oder

ate

to s

ever

e/TA

UT

mod

_sev

0.02

8M

cCro

ne12

0D

ir(13

,18,

4,1)

Tran

sitio

n fr

om m

ild t

o m

inim

al/T

AU

Tm

ild_m

int

0.37

5M

cCro

ne12

0D

ir(9,

10,4

,1)

Tran

sitio

n fr

om m

ild t

o m

ild/T

AU

Tm

ild_m

ildt

0.41

7M

cCro

ne12

0D

ir(9,

10,4

,1)

Tran

sitio

n fr

om m

ild t

o m

oder

ate/

TAU

Tm

ild_m

odt

0.16

7M

cCro

ne12

0D

ir(9,

10,4

,1)

Tran

sitio

n fr

om m

ild t

o se

vere

/TA

UT

mild

_sev

t0.

042

McC

rone

120

Dir(

9,10

,4,1

)Tr

ansit

ion

from

mod

erat

e to

min

imal

/TA

UT

mod

_min

t0.

220

McC

rone

120

Dir(

9,11

,18,

3)Tr

ansit

ion

from

mod

erat

e to

mild

/TA

UT

mod

_mild

t0.

268

McC

rone

120

Dir(

9,11

,18,

3)Tr

ansit

ion

from

mod

erat

e to

mod

erat

e/TA

UT

mod

_mod

t0.

439

McC

rone

120

Dir(

9,11

,18,

3)Tr

ansit

ion

from

mod

erat

e to

sev

ere/

TAU

Tm

od_s

evt

0.07

3M

cCro

ne12

0D

ir(9,

11,1

8,3)

Tran

sitio

n fr

om s

ever

e to

min

imal

/TA

UTs

ev_m

int

0.16

7M

cCro

ne12

0D

ir(4,

2,7,

11)

Tran

sitio

n fr

om s

ever

e to

mild

/TA

UTs

ev_m

ildt

0.08

3M

cCro

ne12

0D

ir(4,

2,7,

11)

Tran

sitio

n fr

om s

ever

e to

mod

erat

e/TA

UTs

ev_m

odt

0.29

2M

cCro

ne12

0D

ir(4,

2,7,

11)

Tran

sitio

n fr

om s

ever

e to

sev

ere/

TAU

Tsev

_sev

t0.

458

McC

rone

120

Dir(

4,2,

7,11

)

cont

inue

d


163


TA

BLE

63

BtB

para

met

ers

(con

t’d)

Var

iabl

eIn

the

tre

eIn

put

Sour

ceD

istr

ibut

ion

Dis

trib

utio

n pa

ram

eter

spa

ram

eter

Qua

lity

of li

fe p

retr

eatm

ent

Q_p

re0.

58Ri

char

ds54

a Be

ta(4

.93,

3.58

)Pa

ram

eter

s fo

und

with

met

hod

of m

omen

tsQ

ualit

y of

life

for

min

imal

dep

ress

ion

Q_m

in0.

88Ri

char

ds54

a Be

ta(1

.443

2,0.

1968

)Q

ualit

y of

life

for

mild

dep

ress

ion

Q_m

ild0.

78Ri

char

ds54

a Be

ta(1

5.74

,4.4

4)Q

ualit

y of

life

for

mod

erat

e de

pres

sion

Q_m

od0.

58Ri

char

ds54

a Be

ta(0

.88,

0.65

)Q

ualit

y of

life

for

seve

re d

epre

ssio

nQ

_sev

0.38

Rich

ards

54a

Beta

(0.4

9,0.

81)

Cos

t of

min

imal

dep

ress

ion

C_m

in12

2.50

M

cCro

ne12

0G

amm

a(1.

96,

Para

met

ers

foun

d w

ith m

etho

d of

mom

ents

(85.

74)

0.01

6)C

ost

of m

ild d

epre

ssio

nC

_mild

253.

50

McC

rone

120

Gam

ma(

0.84

8,(2

75.1

6)0.

003)

Cos

t of

mod

erat

e de

pres

sion

C_m

od27

4.64

M

cCro

ne12

0G

amm

a(0.

295,

(505

.07)

0.00

1)C

ost

of s

ever

e de

pres

sion

C_s

ev42

3.93

M

cCro

ne12

0G

amm

a(0.

32,

(741

.93)

0.00

07)

Cos

t of

BtB

C_l

ic21

9.30

Cos

t in

put

is ln

(5.3

5,0.

25)

Para

met

ers

foun

d w

ith m

etho

d of

mom

ents

for

one

copy

of

BtB

a Para

met

ers

foun

d by

app

lyin

g av

erag

e EQ

-5D

to

each

of t

he fo

ur B

DI c

ateg

orie

s.D

ir, D

irich

let.

TA

BLE

64

BtB

vers

us C

BT

[Com

mer

cial

-in-c

onfid

ence

info

rmat

ion

has

been

rem

oved

.]

Appendix 12

164 TA

BLE

65

BtB

subg

roup

ana

lysis

Var

iabl

eIn

the

tre

eIn

put

Sour

ceD

istr

ibut

ion

Dis

trib

utio

n pa

ram

eter

spa

ram

eter

s

Prob

abili

ty o

f bei

ng in

min

imal

sta

te a

fter

trea

tmen

t/Bt

BPm

inpo

st0.

667

McC

rone

120

Dir(

18,8

,1,0

)Fi

rst

para

met

er r

efle

cts

thos

e w

ho b

ecom

e m

inim

ally

Pr

obab

ility

of b

eing

in m

ild s

tate

afte

r tr

eatm

ent/

BtB

Pmild

post

0.29

6M

cCro

ne12

0D

ir(18

,8,1

,0)

depr

esse

d; s

econ

d pa

ram

eter

ref

lect

s th

ose

who

Pr

obab

ility

of b

eing

in m

oder

ate

stat

e af

ter

trea

tmen

t/Bt

BPm

odpo

st0.

036

McC

rone

120

Dir(

18,8

,1,0

)be

com

e m

ildly

dep

ress

ed; t

hird

par

amet

er r

efle

cts

Prob

abili

ty o

f bei

ng in

sev

ere

stat

e af

ter

trea

tmen

t/Bt

BPs

evpo

st0

McC

rone

120

Dir(

18,8

,1,0

)th

ose

who

bec

ome

mod

erat

ely

depr

esse

d; fo

urth

Pr

obab

ility

of b

eing

in m

inim

al s

tate

afte

r tr

eatm

ent/

TAU

Pmin

ptau

0.37

5M

cCro

ne12

0D

ir(9,

10,4

,1)

para

met

er r

efle

cts

thos

e w

ho b

ecom

e se

vere

ly

Prob

abili

ty o

f bei

ng in

mild

sta

te a

fter

trea

tmen

t/TA

UPm

ildpt

au0.

417

McC

rone

120

Dir(

9,10

,4,1

)de

pres

sed

Prob

abili

ty o

f bei

ng in

mod

erat

e st

ate

afte

r tr

eatm

ent/

TAU

Pmod

ptau

0.16

7M

cCro

ne12

0D

ir(9,

10,4

,1)

Prob

abili

ty o

f bei

ng in

sev

ere

stat

e af

ter

trea

tmen

t/TA

UPs

evpt

au0.

042

McC

rone

120

Dir(

9,10

,4,1

)

Prob

abili

ty o

f dro

ppin

g ou

tPd

rop

0.30

B(7.

2,16

.8)

Firs

t pa

ram

eter

ref

lect

s nu

mbe

r of

eve

nts,

sec

ond

para

met

er r

efle

cts

thos

e w

ho d

o no

t ex

perie

nce

the

even

t

Prob

abili

ty o

f bei

ng in

min

imal

sta

te a

fter

trea

tmen

t/Bt

BPm

inpo

st0.

361

McC

rone

120

Dir(

13,1

8,4,

1)Fi

rst

para

met

er r

efle

cts

thos

e w

ho b

ecom

e m

inim

ally

Pr

obab

ility

of b

eing

in m

ild s

tate

afte

r tr

eatm

ent/

BtB

Pmild

post

0.5

McC

rone

120

Dir(

13,1

8,4,

1)de

pres

sed;

sec

ond

para

met

er r

efle

cts

thos

e w

ho

Prob

abili

ty o

f bei

ng in

mod

erat

e st

ate

afte

r tr

eatm

ent/

BtB

Pmod

post

0.11

1M

cCro

ne12

0D

ir(13

,18,

4,1)

beco

me

mild

ly d

epre

ssed

; thi

rd p

aram

eter

ref

lect

s Pr

obab

ility

of b

eing

in s

ever

e st

ate

afte

r tr

eatm

ent/

BtB

Psev

post

0.02

8M

cCro

ne12

0D

ir(13

,18,

4,1)

thos

e w

ho b

ecom

e m

oder

atel

y de

pres

sed;

four

th

Prob

abili

ty o

f bei

ng in

min

imal

sta

te a

fter

trea

tmen

t/TA

UPm

inpt

au0.

220

McC

rone

120

Dir(

9,11

,18,

3)pa

ram

eter

ref

lect

s th

ose

who

bec

ome

seve

rely

Pr

obab

ility

of b

eing

in m

ild s

tate

afte

r tr

eatm

ent/

TAU

Pmild

ptau

0.26

8M

cCro

ne12

0D

ir(9,

11,1

8,3)

depr

esse

dPr

obab

ility

of b

eing

in m

oder

ate

stat

e af

ter

trea

tmen

t/TA

UPm

odpt

au0.

439

McC

rone

120

Dir(

9,11

,18,

3)Pr

obab

ility

of b

eing

in s

ever

e st

ate

afte

r tr

eatm

ent/

TAU

Psev

ptau

0.07

3M

cCro

ne12

0D

ir(9,

11,1

8,3)

Prob

abili

ty o

f dro

ppin

g ou

tPd

rop

0.3

Dir(

10.8

,25.

2)Fi

rst

para

met

er r

efle

cts

num

ber

of e

vent

s, s

econ

dpa

ram

eter

ref

lect

s th

ose

who

do

not

expe

rienc

e th

eev

ent

Prob

abili

ty o

f bei

ng in

min

imal

sta

te a

fter

trea

tmen

t/Bt

BPm

inpo

st0.

250

McC

rone

120

Firs

t pa

ram

eter

ref

lect

s th

ose

who

bec

ome

min

imal

ly

Prob

abili

ty o

f bei

ng in

mild

sta

te a

fter

trea

tmen

t/Bt

BPm

ildpo

st0.

250

McC

rone

120

depr

esse

d; s

econ

d pa

ram

eter

ref

lect

s th

ose

who

Pr

obab

ility

of b

eing

in m

oder

ate

stat

e af

ter

trea

tmen

t/Bt

BPm

odpo

st0.

250

McC

rone

120

beco

me

mild

ly d

epre

ssed

; thi

rd p

aram

eter

ref

lect

s Pr

obab

ility

of b

eing

in s

ever

e st

ate

afte

r tr

eatm

ent/

BtB

Psev

post

0.25

0M

cCro

ne12

0th

ose

who

bec

ome

mod

erat

ely

depr

esse

d; fo

urth

Pr

obab

ility

of b

eing

in m

inim

al s

tate

afte

r tr

eatm

ent/

TAU

Pmin

ptau

0.16

7M

cCro

ne12

0pa

ram

eter

ref

lect

s th

ose

who

bec

ome

seve

rely

Pr

obab

ility

of b

eing

in m

ild s

tate

afte

r tr

eatm

ent/

TAU

Pmild

ptau

0.08

3M

cCro

ne12

0de

pres

sed

Prob

abili

ty o

f bei

ng in

mod

erat

e st

ate

afte

r tr

eatm

ent/

TAU

Pmod

ptau

0.29

2M

cCro

ne12

0

Prob

abili

ty o

f bei

ng in

sev

ere

stat

e af

ter

trea

tmen

t/TA

UPs

evpt

au0.

458

McC

rone

120

Prob

abili

ty o

f dro

ppin

g ou

tPd

rop

0.3

B(7.

2,16

.8)

Firs

t pa

ram

eter

ref

lect

s nu

mbe

r of

eve

nts,

sec

ond

para

met

er r

efle

cts

thos

e w

ho d

o no

t ex

perie

nce

the

even

t


165


TA

BLE

66

Para

met

er v

alue

s fo

r Cop

e

Var

iabl

eIn

the

tre

eIn

put

Sour

ce

Dis

trib

utio

nD

istr

ibut

ion

para

met

ers

para

met

ers

Prob

abili

ty m

inim

al p

ost-

CC

BTPm

inpo

st0.

156

Mar

ks89

Dir(

4.23

,12.

12,9

.93,

0.95

)Fi

rst

para

met

er r

efle

cts

thos

e w

ho b

ecom

e m

inim

ally

Pr

obab

ility

mild

pos

t-C

CBT

Pmild

post

0.44

5M

arks

89D

ir(4.

23,1

2.12

,9.9

3,0.

95)

depr

esse

d af

ter

Cop

e; s

econ

d pa

ram

eter

ref

lect

s Pr

obab

ility

mod

erat

e po

st-C

CBT

Pmod

post

0.36

5M

arks

89D

ir(4.

23,1

2.12

,9.9

3,0.

95)

thos

e w

ho b

ecom

e m

ildly

dep

ress

ed a

fter

Cop

e; t

hird

Pr

obab

ility

sev

ere

post

-CC

BTPs

evpo

st0.

035

Mar

ks89

Dir(

4.23

,12.

12,9

.93,

0.95

)pa

ram

eter

ref

lect

s th

ose

who

bec

ome

mod

erat

ely

depr

esse

d af

ter

Cop

e; fo

urth

par

amet

er r

efle

cts

thos

ew

ho b

ecom

e se

vere

ly d

epre

ssed

afte

r C

ope

Prob

abili

ty m

inim

al p

ost-T

AU

Pmin

ptau

0.26

9M

arks

89D

ir(8.

608,

8.25

6,9.

984,

5.15

)Pa

ram

eter

s ha

ve b

een

scal

ed d

own

to r

efle

ct t

he

Prob

abili

ty m

ild p

ost-T

AU

Pmild

ptau

0.25

8M

arks

89D

ir(8.

608,

8.25

6,9.

984,

5.15

)ac

tual

sam

ple

size

of t

he s

tudy

Prob

abili

ty m

oder

ate

post

-CC

BTPm

odpt

au0.

312

Mar

ks89

Dir(

8.60

8,8.

256,

9.98

4,5.

15)

Prob

abili

ty s

ever

e po

st-C

CBT

Psev

ptau

0.16

1M

arks

89D

ir(8.

608,

8.25

6,9.

984,

5.15

)

Prob

abili

ty o

f dro

ppin

g ou

tP_

drop

0.30

Prob

abili

ty o

f B(

11.7

,27.

3)Fi

rst

para

met

er r

efle

cts

num

ber

of e

vent

s, s

econ

d dr

oppi

ng o

ut

para

met

er r

efle

cts

thos

e no

t ex

perie

ncin

g th

e ev

ent

from

Cop

e

Cos

t of

Cop

eC

_lic

195.

86C

ost

at G

P ln

(5.2

5, 0

.25)

Met

hod

of m

omen

ts. P

aram

eter

s ca

lcul

ated

to

refle

ct

prac

tice

leve

lun

cert

aint

y at

a G

P pr

actic

e le

vel

Appendix 12

166 TA

BLE

67

Para

met

er v

alue

s fo

r Ove

rcom

ing

Dep

ress

ion

Var

iabl

eIn

the

tre

eIn

put

Sour

ceD

istr

ibut

ion

Dis

trib

utio

n pa

ram

eter

spa

ram

eter

s

Prob

abili

ty m

inim

al p

ost-

CC

BTPm

inpo

st0.

267

Whi

tfiel

d93D

ir(4,

4,5,

2)Fi

rst

para

met

er r

efle

cts

thos

e w

ho b

ecom

e m

inim

ally

dep

ress

ed a

fter

Prob

abili

ty m

ild p

ost-

CC

BTPm

ildpo

st0.

267

Whi

tfiel

d93D

ir(4,

4,5,

2)O

verc

omin

g D

epre

ssio

n; s

econ

d pa

ram

eter

ref

lect

s th

ose

who

Pr

obab

ility

mod

erat

e po

st-C

CBT

Pmod

post

0.33

3W

hitfi

eld93

Dir(

4,4,

5,2)

beco

me

mild

ly d

epre

ssed

afte

r O

verc

omin

g D

epre

ssio

n; t

hird

Pr

obab

ility

sev

ere

post

-CC

BTPs

evpo

st0.

133

Whi

tfiel

d93D

ir(4,

4,5,

2)pa

ram

eter

ref

lect

s th

ose

who

bec

ome

mod

erat

ely

depr

esse

d af

ter

Ove

rcom

ing

Dep

ress

ion;

four

th p

aram

eter

ref

lect

s th

ose

who

beco

me

seve

rely

dep

ress

ed a

fter

Ove

rcom

ing

Dep

ress

ion

Qua

lity

of li

fe p

retr

eatm

ent

Q_p

re0.

51W

hitfi

eld93

Beta

(4.9

7,3.

27)

Cal

cula

ted

usin

g m

etho

d of

mom

ents

Prob

abili

ty m

inim

al p

ost-T

AU

Pmin

ptau

0.26

9D

ir(4.

035,

3.87

,4.6

8,2.

415)

Para

met

ers

have

bee

n sc

aled

dow

n to

ref

lect

the

act

ual s

ampl

e siz

e Pr

obab

ility

mild

pos

t-TA

UPm

ildpt

au0.

258

Dir(

4.03

5,3.

87,4

.68,

2.41

5)of

the

stu

dyPr

obab

ility

mod

erat

e po

st-C

CBT

Pmod

ptau

0.31

2D

ir(4.

035,

3.87

,4.6

8,2.

415)

Prob

abili

ty s

ever

e po

st-C

CBT

Psev

ptau

0.16

1D

ir(4.

035,

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167


average EQ-5D score was calculated, by linkingtheir severity category to the respective EQ-5D scorein Appendix 10. The quality of life score is slightlylower than in Cope and BtB (0.51 versus 0.55).

The new data for the model are shown in Table 67.All other data (including those for TAU) are thesame as in Table 63).

As for Cope, a PSA was for OvercomingDepression, replacing some probability distributionsand substituting new ones from the original model.

The probability of being in one of the four statespost-therapy was modelled with a Dirichletdistribution. The parameters were calculatedaccording to the number of people in eachcategory immediately post-treatment. Theparameters are very low as the sample size wascomposed of only 15 individuals. The probabilityof dropping out was calculated by scaling downthe parameters to the actual sample size of thestudy. Lower parameters in both the beta and theDirichlet distribution increase uncertainty in themodel. A log-normal distribution was fitted to thecost of the licence to reflect the uncertainty in therange and the skewness of this cost. Table 67 showsthe probability distribution placed on the newparameters. All the other parameters have thesame distributions as in Table 63.

FearFighterTable 68 shows the data used to populate themodel. Response rates were estimated by placing anormal distribution with mean and standarddeviation equal to those of the score post-treatment of the global phobia item of the FQ.Table 68 shows the distribution placed on theparameters input to perform the PSA.

BT StepsTable 69 shows the parameters chosen for themodel and the distribution to perform PSA.Response rate has been calculated placing anormal distribution centred in the mean andstandard deviation of YBOCS post-treatment. As the baseline corresponds to a score of 25, the 35% improvement was calculated andsubtracted from 25 to obtain 16.25. On thatnormal distribution the proportion of thosescoring less than 16.25 was calculated asresponders. Data from the ESEMeD survey153

reported on EQ-5D and YBOCS. A regression wascarried out to link YBOCS to EQ-5D. As valuesfrom the ESEMeD survey153 were only on theobsessive scale (excluding the compulsive scale),those values were halved to allow thetransformation.

Appendix 12

168 TA

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183

Health Technology AssessmentProgramme

Prioritisation Strategy GroupMembers

Chair,Professor Tom Walley, Director, NHS HTA Programme,Department of Pharmacology &Therapeutics,University of Liverpool

Professor Bruce Campbell,Consultant Vascular & GeneralSurgeon, Royal Devon & ExeterHospital

Dr Edmund Jessop, MedicalAdvisor, National Specialist,Commissioning Advisory Group(NSCAG), Department ofHealth, London

Professor Jon Nicholl, Director,Medical Care Research Unit,University of Sheffield, Schoolof Health and Related Research

Dr John Reynolds, ClinicalDirector, Acute GeneralMedicine SDU, RadcliffeHospital, Oxford

Dr Ron Zimmern, Director,Public Health Genetics Unit,Strangeways ResearchLaboratories, Cambridge

Director, Professor Tom Walley, Director, NHS HTA Programme,Department of Pharmacology &Therapeutics,University of Liverpool

Deputy Director, Professor Jon Nicholl,Director, Medical Care ResearchUnit, University of Sheffield,School of Health and RelatedResearch

HTA Commissioning BoardMembers

Programme Director, Professor Tom Walley, Director, NHS HTA Programme,Department of Pharmacology &Therapeutics,University of Liverpool

Chair,Professor Jon Nicholl,Director, Medical Care ResearchUnit, University of Sheffield,School of Health and RelatedResearch

Deputy Chair, Professor Jenny Hewison,Professor of Health CarePsychology, Academic Unit ofPsychiatry and BehaviouralSciences, University of LeedsSchool of Medicine

Dr Jeffrey AronsonReader in ClinicalPharmacology, Department ofClinical Pharmacology,Radcliffe Infirmary, Oxford

Professor Deborah Ashby,Professor of Medical Statistics,Department of Environmentaland Preventative Medicine,Queen Mary University ofLondon

Professor Ann Bowling,Professor of Health ServicesResearch, Primary Care andPopulation Studies,University College London

Dr Andrew Briggs, PublicHealth Career Scientist, HealthEconomics Research Centre,University of Oxford

Professor John Cairns, Professorof Health Economics, PublicHealth Policy, London School ofHygiene and Tropical Medicine,London

Professor Nicky Cullum,Director of Centre for EvidenceBased Nursing, Department ofHealth Sciences, University ofYork

Mr Jonathan Deeks, Senior Medical Statistician,Centre for Statistics inMedicine, University of Oxford

Dr Andrew Farmer, SeniorLecturer in General Practice,Department of Primary Health Care, University of Oxford

Professor Fiona J Gilbert,Professor of Radiology,Department of Radiology,University of Aberdeen

Professor Adrian Grant,Director, Health ServicesResearch Unit, University ofAberdeen

Professor F D Richard Hobbs,Professor of Primary Care &General Practice, Department ofPrimary Care & GeneralPractice, University ofBirmingham

Professor Peter Jones, Head ofDepartment, UniversityDepartment of Psychiatry,University of Cambridge

Professor Sallie Lamb, Professor of Rehabilitation,Centre for Primary Health Care, University of Warwick

Professor Stuart Logan,Director of Health & SocialCare Research, The Peninsula Medical School, Universities of Exeter &Plymouth

Dr Linda Patterson, Consultant Physician,Department of Medicine,Burnley General Hospital

Professor Ian Roberts, Professorof Epidemiology & PublicHealth, Intervention ResearchUnit, London School ofHygiene and Tropical Medicine

Professor Mark Sculpher,Professor of Health Economics,Centre for Health Economics,Institute for Research in theSocial Services, University of York

Dr Jonathan Shapiro, SeniorFellow, Health ServicesManagement Centre,Birmingham

Ms Kate Thomas,Deputy Director,Medical Care Research Unit,University of Sheffield

Ms Sue Ziebland,Research Director, DIPEx,Department of Primary HealthCare, University of Oxford,Institute of Health Sciences

Current and past membership details of all HTA ‘committees’ are available from the HTA website (www.hta.ac.uk)


Health Technology Assessment Programme

184

Diagnostic Technologies & Screening PanelMembers

Chair,Dr Ron Zimmern, Director ofthe Public Health Genetics Unit,Strangeways ResearchLaboratories, Cambridge

Ms Norma Armston,Lay Member, Bolton

Professor Max BachmannProfessor of Health Care Interfaces, Department of Health Policy and Practice,University of East Anglia

Professor Rudy BilousProfessor of Clinical Medicine &Consultant Physician,The Academic Centre,South Tees Hospitals NHS Trust

Dr Paul Cockcroft, Consultant MedicalMicrobiologist and ClinicalDirector of Pathology,Department of ClinicalMicrobiology, St Mary'sHospital, Portsmouth

Professor Adrian K Dixon,Professor of Radiology,University Department ofRadiology, University ofCambridge Clinical School

Dr David Elliman, Consultant Paediatrician/Hon. Senior Lecturer,Population Health Unit, Great Ormond St. Hospital,London

Professor Glyn Elwyn,Primary Medical Care Research Group,Swansea Clinical School,University of Wales Swansea

Mr Tam Fry, HonoraryChairman, Child GrowthFoundation, London

Dr Jennifer J Kurinczuk,Consultant ClinicalEpidemiologist,National PerinatalEpidemiology Unit, Oxford

Dr Susanne M Ludgate, MedicalDirector, Medicines &Healthcare Products RegulatoryAgency, London

Professor William Rosenberg,Professor of Hepatology, LiverResearch Group, University ofSouthampton

Dr Susan Schonfield, Consultantin Public Health, SpecialisedServices Commissioning NorthWest London, HillingdonPrimary Care Trust

Dr Phil Shackley, SeniorLecturer in Health Economics,School of Population andHealth Sciences, University ofNewcastle upon Tyne

Dr Margaret Somerville, PMSPublic Health Lead, PeninsulaMedical School, University ofPlymouth

Dr Graham Taylor, ScientificDirector & Senior Lecturer,Regional DNA Laboratory, TheLeeds Teaching Hospitals

Professor Lindsay WilsonTurnbull, Scientific Director,Centre for MR Investigations &YCR Professor of Radiology,University of Hull

Professor Martin J Whittle,Associate Dean for Education,Head of Department ofObstetrics and Gynaecology,University of Birmingham

Dr Dennis Wright, Consultant Biochemist &Clinical Director, Pathology & The KennedyGalton Centre, Northwick Park & St Mark’sHospitals, Harrow

Pharmaceuticals PanelMembers

Chair,Dr John Reynolds, ChairDivision A, The John RadcliffeHospital, Oxford RadcliffeHospitals NHS Trust

Professor Tony Avery, Head of Division of PrimaryCare, School of CommunityHealth Services, Division ofGeneral Practice, University ofNottingham

Ms Anne Baileff, ConsultantNurse in First Contact Care,Southampton City Primary CareTrust, University ofSouthampton

Professor Stirling Bryan,Professor of Health Economics,Health Services Management Centre,University of Birmingham

Mr Peter Cardy, ChiefExecutive, Macmillan CancerRelief, London

Professor Imti Choonara,Professor in Child Health,Academic Division of ChildHealth, University ofNottingham

Dr Robin Ferner, ConsultantPhysician and Director, WestMidlands Centre for AdverseDrug Reactions, City HospitalNHS Trust, Birmingham

Dr Karen A Fitzgerald,Consultant in PharmaceuticalPublic Health, National PublicHealth Service for Wales,Cardiff

Mrs Sharon Hart, Head of DTB Publications, Drug &Therapeutics Bulletin, London

Dr Christine Hine, Consultant inPublic Health Medicine, SouthGloucestershire Primary CareTrust

Professor Stan Kaye,Cancer Research UK Professor of Medical Oncology,Section of Medicine, The Royal Marsden Hospital,Sutton

Ms Barbara Meredith,Lay Member, Epsom

Dr Andrew Prentice, SeniorLecturer and ConsultantObstetrician & Gynaecologist,Department of Obstetrics &Gynaecology, University ofCambridge

Dr Frances Rotblat, CPMPDelegate, Medicines &Healthcare Products RegulatoryAgency, London

Professor Jan Scott, Professor of Psychological Treatments,Institute of Psychiatry,University of London

Mrs Katrina Simister, AssistantDirector New Medicines,National Prescribing Centre,Liverpool

Dr Richard Tiner, MedicalDirector, Medical Department,Association of the BritishPharmaceutical Industry,London

Dr Helen Williams,Consultant Microbiologist,Norfolk & Norwich UniversityHospital NHS Trust

Current and past membership details of all HTA ‘committees’ are available from the HTA website (www.hta.ac.uk)

Therapeutic Procedures PanelMembers

Chair, Professor Bruce Campbell,Consultant Vascular andGeneral Surgeon, Departmentof Surgery, Royal Devon &Exeter Hospital

Dr Aileen Clarke,Reader in Health ServicesResearch, Public Health &Policy Research Unit, Barts &the London School of Medicine& Dentistry, London

Dr Matthew Cooke, Reader inA&E/Department of HealthAdvisor in A&E, WarwickEmergency Care andRehabilitation, University ofWarwick

Dr Carl E Counsell, ClinicalSenior Lecturer in Neurology,Department of Medicine andTherapeutics, University ofAberdeen

Ms Amelia Curwen, ExecutiveDirector of Policy, Services andResearch, Asthma UK, London

Professor Gene Feder, Professorof Primary Care R&D,Department of General Practiceand Primary Care, Barts & theLondon, Queen Mary’s Schoolof Medicine and Dentistry,London

Professor Paul Gregg,Professor of OrthopaedicSurgical Science, Department ofGeneral Practice and PrimaryCare, South Tees Hospital NHSTrust, Middlesbrough

Ms Bec Hanley, Co-Director,TwoCan Associates,Hurstpierpoint

Ms Maryann L Hardy, Lecturer, Division ofRadiography, University ofBradford

Professor Alan Horwich,Director of Clinical R&D,Academic Department ofRadiology, The Institute ofCancer Research, London

Dr Simon de Lusignan,Senior Lecturer, Primary Care Informatics,Department of CommunityHealth Sciences,St George’s Hospital MedicalSchool, London

Professor Neil McIntosh,Edward Clark Professor of Child Life & Health,Department of Child Life &Health, University of Edinburgh

Professor James Neilson,Professor of Obstetrics andGynaecology, Department ofObstetrics and Gynaecology,University of Liverpool

Dr John C Pounsford,Consultant Physician,Directorate of Medical Services,North Bristol NHS Trust

Karen Roberts, NurseConsultant, Queen ElizabethHospital, Gateshead

Dr Vimal Sharma, ConsultantPsychiatrist/Hon. Senior Lecturer,Mental Health Resource Centre,Cheshire and Wirral PartnershipNHS Trust, Wallasey

Dr L David Smith, ConsultantCardiologist, Royal Devon &Exeter Hospital

Professor Norman Waugh,Professor of Public Health,Department of Public Health,University of Aberdeen


185Current and past membership details of all HTA ‘committees’ are available from the HTA website (www.hta.ac.uk)

Health Technology Assessment Programme

186Current and past membership details of all HTA ‘committees’ are available from the HTA website (www.hta.ac.uk)

Expert Advisory NetworkMembers

Professor Douglas Altman,Director of CSM & CancerResearch UK Med Stat Gp,Centre for Statistics inMedicine, University of Oxford,Institute of Health Sciences,Headington, Oxford

Professor John Bond,Director, Centre for HealthServices Research, University ofNewcastle upon Tyne, School ofPopulation & Health Sciences,Newcastle upon Tyne

Mr Shaun Brogan, Chief Executive, RidgewayPrimary Care Group, Aylesbury

Mrs Stella Burnside OBE,Chief Executive, Office of theChief Executive. TrustHeadquarters, AltnagelvinHospitals Health & SocialServices Trust, Altnagelvin AreaHospital, Londonderry

Ms Tracy Bury, Project Manager, WorldConfederation for PhysicalTherapy, London

Professor Iain T Cameron,Professor of Obstetrics andGynaecology and Head of theSchool of Medicine,University of Southampton

Dr Christine Clark,Medical Writer & ConsultantPharmacist, Rossendale

Professor Collette Clifford,Professor of Nursing & Head ofResearch, School of HealthSciences, University ofBirmingham, Edgbaston,Birmingham

Professor Barry Cookson,Director, Laboratory ofHealthcare Associated Infection,Health Protection Agency,London

Professor Howard Cuckle,Professor of ReproductiveEpidemiology, Department ofPaediatrics, Obstetrics &Gynaecology, University ofLeeds

Dr Katherine Darton, Information Unit, MIND – The Mental Health Charity,London

Professor Carol Dezateux, Professor of PaediatricEpidemiology, London

Mr John Dunning,Consultant CardiothoracicSurgeon, CardiothoracicSurgical Unit, PapworthHospital NHS Trust, Cambridge

Mr Jonothan Earnshaw,Consultant Vascular Surgeon,Gloucestershire Royal Hospital,Gloucester

Professor Martin Eccles, Professor of ClinicalEffectiveness, Centre for HealthServices Research, University ofNewcastle upon Tyne

Professor Pam Enderby,Professor of CommunityRehabilitation, Institute ofGeneral Practice and PrimaryCare, University of Sheffield

Mr Leonard R Fenwick, Chief Executive, Newcastleupon Tyne Hospitals NHS Trust

Professor David Field, Professor of Neonatal Medicine,Child Health, The LeicesterRoyal Infirmary NHS Trust

Mrs Gillian Fletcher, Antenatal Teacher & Tutor andPresident, National ChildbirthTrust, Henfield

Professor Jayne Franklyn,Professor of Medicine,Department of Medicine,University of Birmingham,Queen Elizabeth Hospital,Edgbaston, Birmingham

Ms Grace Gibbs, Deputy Chief Executive,Director for Nursing, Midwifery& Clinical Support Services, West Middlesex UniversityHospital, Isleworth

Dr Neville Goodman, Consultant Anaesthetist,Southmead Hospital, Bristol

Professor Alastair Gray,Professor of Health Economics,Department of Public Health,University of Oxford

Professor Robert E Hawkins, CRC Professor and Director ofMedical Oncology, Christie CRCResearch Centre, ChristieHospital NHS Trust, Manchester

Professor Allen Hutchinson, Director of Public Health &Deputy Dean of ScHARR,Department of Public Health,University of Sheffield

Dr Duncan Keeley,General Practitioner (Dr Burch& Ptnrs), The Health Centre,Thame

Dr Donna Lamping,Research Degrees ProgrammeDirector & Reader in Psychology,Health Services Research Unit,London School of Hygiene andTropical Medicine, London

Mr George Levvy,Chief Executive, MotorNeurone Disease Association,Northampton

Professor James Lindesay,Professor of Psychiatry for theElderly, University of Leicester,Leicester General Hospital

Professor Julian Little,Professor of Human GenomeEpidemiology, Department ofEpidemiology & CommunityMedicine, University of Ottawa

Professor Rajan Madhok, Medical Director & Director ofPublic Health, Directorate ofClinical Strategy & PublicHealth, North & East Yorkshire& Northern Lincolnshire HealthAuthority, York

Professor David Mant, Professor of General Practice,Department of Primary Care,University of Oxford

Professor Alexander Markham, Director, Molecular MedicineUnit, St James’s UniversityHospital, Leeds

Dr Chris McCall, General Practitioner, TheHadleigh Practice, Castle Mullen

Professor Alistair McGuire,Professor of Health Economics,London School of Economics

Dr Peter Moore, Freelance Science Writer, Ashtead

Dr Sue Moss, Associate Director,Cancer Screening EvaluationUnit, Institute of CancerResearch, Sutton

Mrs Julietta Patnick, Director, NHS Cancer ScreeningProgrammes, Sheffield

Professor Tim Peters,Professor of Primary CareHealth Services Research,Academic Unit of PrimaryHealth Care, University ofBristol

Professor Chris Price, Visiting Chair – Oxford, ClinicalResearch, Bayer DiagnosticsEurope, Cirencester

Professor Peter Sandercock,Professor of Medical Neurology,Department of ClinicalNeurosciences, University ofEdinburgh

Dr Eamonn Sheridan,Consultant in Clinical Genetics,Genetics Department,St James’s University Hospital,Leeds

Dr Ken Stein,Senior Clinical Lecturer inPublic Health, Director,Peninsula TechnologyAssessment Group, University of Exeter

Professor Sarah Stewart-Brown, Professor of Public Health,University of Warwick, Division of Health in theCommunity Warwick MedicalSchool, LWMS, Coventry

Professor Ala Szczepura, Professor of Health ServiceResearch, Centre for HealthServices Studies, University ofWarwick

Dr Ross Taylor, Senior Lecturer, Department ofGeneral Practice and PrimaryCare, University of Aberdeen

Mrs Joan Webster, Consumer member, HTA –Expert Advisory Network

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HTA

Health Technology Assessm

ent 2006;Vol. 10: No. 33

Com

puterised cognitive behaviour therapy for depression and anxiety update

Computerised cognitive behaviour therapy for depression and anxietyupdate: a systematic review and economic evaluation

E Kaltenthaler, J Brazier, E De Nigris, I Tumur, M Ferriter, C Beverley, G Parry, G Rooney and P Sutcliffe


HTAHealth Technology AssessmentNHS R&D HTA Programme

The National Coordinating Centre for Health Technology Assessment,Mailpoint 728, Boldrewood,University of Southampton,Southampton, SO16 7PX, UK.Fax: +44 (0) 23 8059 5639 Email: [email protected]://www.hta.ac.uk ISSN 1366-5278

FeedbackThe HTA Programme and the authors would like to know

your views about this report.

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your comments. If you prefer, you can send your comments to the address below, telling us whether you would like

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We look forward to hearing from you.

September 2006

nhs r&d hta programmewrap.warwick.ac.uk/46334/2/wrap_sutcliffe... · j brazier, 1. e de nigris,...

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