Behavioural Activation for Depression

David Ekers PhD, MSc, ENB 650 (CBT), RMN

What is Behavioural ActivationViews depression as based in interaction with environment-Loss of positive reinforcement

Uses behavioural theory

Largely forgotten in favor of CBT over past 3 decades

Potentially simple to deliver possibly suited to wider dissemination ‘less moving parts’

This may then be of particular use if it remains as effective

OUR RESEARCH STORY SO FAR

Landmark study-Component Analysis of CT for Depression (Jacobson et al 1996)

2 ye ar

6 m on th

B a se lin e (n= 5 7)

B e ha v iou ra l A c tiv a tio n a lo ne

2 ye a r

6 m on th

B a s le line (n = 4 4)

A c tiv a tio n a n d th ou gh t m o d if ic a tion

2 ye ar

6 m on th

B a se lin e (n= 5 0)

F u ll C T

1 5 0 P a tien ts w ith m a jo r de p res s ion id en tif ie d fo r s tu d y ra n do m a llo ca tion to a rm s

Systematic review and Meta-analysis of behavioural treatment for depression

Psychological Medicine 2008; 38(5): 611-623.

What a meta analysis tells us

The combined effect over a number of studies

Is there importance variance across findings of studies

Is there evidence of important studies missing

Generally reports ‘effect size’ as standardised mean difference0.33-0.55 moderate0.55 and above large effects

Findings

BA vs. Control/Usual Care 12 studies (459 participants) Effect size -0.70 in favour of BA (large) (95% CI −0.39 to −1, p=0.001),

recovery rate favours BA OR= 4.18 CI 1.14 to 15.28 (p=0.03)

BA vs. CT/CBT Twelve studies (476 patients) No difference effect size at post treatment and follow up (SMD 0.08 95%

CI −0.14 to 0.30, SMD of 0.25, 95% CI −0.21 to 0.70, p=0.28) or recovery rate (OR 0.92, 95% CI 0.59 to1.44, p=0.72)

Review : Behavioural Activation for DepressionComparison: 04 Behavioural vs control Outcome: 01 SMD all studies BT vs Waitlist/Placebo Control/TAU

Study Behavioural Wait List SMD (random) SMD (random)or sub-category N Mean (SD) N Mean (SD) 95% CI 95% CI

Wilson 1982 (relax) 6 12.42(9.38) 10 8.50(6.35) 0.49 [-0.54, 1.52] Wilson 1983 8 7.50(4.55) 9 21.44(5.52) -2.60 [-3.98, -1.22] Taylor 1977 7 10.70(5.00) 7 20.10(5.80) -1.63 [-2.89, -0.36] Mclean 1979 42 9.70(8.00) 43 14.95(8.00) -0.65 [-1.09, -0.21] Maldonado Lopez 1982 8 7.38(3.74) 8 17.63(8.33) -1.50 [-2.65, -0.35] Wilson 1982 6 12.42(9.38) 10 14.60(9.73) -0.21 [-1.23, 0.80] Wilson 1982 (PLA) 5 11.89(10.87) 12 14.67(11.12) -0.24 [-1.29, 0.81] Wilson 1982 (PLA/re) 4 11.89(10.87) 10 16.55(10.36) -0.42 [-1.59, 0.76] Cole1983 15 26.40(8.00) 15 31.20(8.00) -0.58 [-1.32, 0.15] Skinner 1984 8 14.62(5.90) 9 18.33(4.92) -0.65 [-1.64, 0.33] Thompson 1987 30 12.40(7.80) 19 22.48(7.82) -1.27 [-1.90, -0.64] Scogin1989 19 9.70(5.70) 21 15.90(6.90) -0.96 [-1.61, -0.30] McKendree Smith 1998 13 12.00(13.15) 14 14.79(9.63) -0.24 [-0.99, 0.52] Cullen 2006 6 3.83(3.31) 8 28.25(16.31) -1.81 [-3.13, -0.49] Dimidjian 2006 22 16.82(8.56) 31 22.50(12.97) -0.49 [-1.05, 0.06] Dimidjian 2006 (ls) 15 15.33(10.03) 19 14.68(7.81) 0.07 [-0.61, 0.75]

Total (95% CI) 214 245 -0.70 [-1.00, -0.39]Test for heterogeneity: Chi² = 31.54, df = 15 (P = 0.007), I² = 52.4%Test for overall ef fect: Z = 4.50 (P < 0.00001)

-4 -2 0 2 4

Favours Behavioural Favours control

Review : Behavioural Activation for DepressionComparison: 06 SMD BT vs CBT Outcome: 01 BT vs CT Symptom Level

Study Behavioural Therapy Cognitive Therapy SMD (random) SMD (random)or sub-category N Mean (SD) N Mean (SD) 95% CI 95% CI

01 Symptom Level post TreatmentWilson 1983 8 7.50(4.55) 8 9.00(6.82) -0.24 [-1.23, 0.74] Taylor 1977 4 10.70(5.00) 7 10.30(2.60) 0.10 [-1.13, 1.33] Taylor 1977 (CBT) 3 10.70(5.00) 7 5.60(4.70) 0.96 [-0.49, 2.42] Gallaher1982 10 12.62(11.97) 10 9.71(5.74) 0.30 [-0.59, 1.18] Maldonado Lopez 1982 8 7.38(3.74) 8 4.88(3.80) 0.63 [-0.38, 1.64] Maldonado Lopez 1984 8 16.35(5.37) 8 6.37(7.81) 1.41 [0.28, 2.54] Skinner 1984 8 14.62(5.90) 7 15.00(7.40) -0.05 [-1.07, 0.96] McNamara 1986 5 5.50(3.56) 10 6.50(4.17) -0.24 [-1.31, 0.84] MvNamara 1986 (CBT) 5 5.50(3.56) 10 4.80(3.55) 0.19 [-0.89, 1.26] Thompson 1987 30 12.40(7.80) 31 13.60(10.10) -0.13 [-0.63, 0.37] Scogin1989 19 9.70(5.70) 21 7.50(3.60) 0.46 [-0.17, 1.09] Jacobson 1996 28 9.10(7.90) 50 10.10(9.60) -0.11 [-0.57, 0.35] Jacobson1996 (AT) 28 9.10(7.90) 43 10.60(9.30) -0.17 [-0.65, 0.31] McKendree Smith 1998 13 12.00(13.15) 13 5.62(4.33) 0.63 [-0.16, 1.42] Dimidjian 2006 16 8.75(7.96) 18 17.44(15.57) -0.67 [-1.37, 0.02] Dimidjian 2006 (ls) 15 11.00(10.08) 17 9.76(8.15) 0.13 [-0.56, 0.83]

Subtotal (95% CI) 208 268 0.08 [-0.14, 0.30]Test for heterogeneity: Chi² = 19.01, df = 15 (P = 0.21), I² = 21.1%Test for overall effect: Z = 0.75 (P = 0.46)

02 Symptom level Follow upGallaher1982 9 9.89(9.47) 10 9.78(5.67) 0.01 [-0.89, 0.91] Scogin1989 14 9.10(6.30) 15 8.90(6.00) 0.03 [-0.70, 0.76] Jacobson 1996 25 8.50(7.60) 47 10.30(8.60) -0.22 [-0.70, 0.27] Jacobson1996 (AT) 25 8.50(7.60) 39 9.30(8.20) -0.10 [-0.60, 0.40]

Subtotal (95% CI) 73 111 -0.11 [-0.41, 0.19]Test for heterogeneity: Chi² = 0.40, df = 3 (P = 0.94), I² = 0%Test for overall effect: Z = 0.71 (P = 0.47)

-4 -2 0 2 4

Favours BT Favours CT

Possible implications of findings

BA works compared to control

No apparent added benefit of cognitive components

BA appears strong in relation to other therapies

Limitations of evidence baseNo cost analysis/Small studies/Limited numbers in comparisons beyond BA vs. Control and CBTAll ‘experienced therapists’

So still big questionsDoes BA’s equivalence maintain with less ‘qualified’ therapists? (as per Jacobson 1996)Parsimony- but if a simple intervention is delivered by ‘expert therapists’ what is active ingredient?No help to improving access to evidenced based therapies if reliant on ‘experts’

Do we need more therapies for delivery by the same therapists?? (or more meta analysis from the same studies)

Behavioural activation delivered by the non specialist: Phase II randomised controlled trial

D Ekers, D. Richards, S Gilbody, D McMillan & M Bland

British Journal of Psychiatry 2011

Results68 referrals (41 GP, 27 PCMH)Excluded: diagnosis 17, refused 2, risk 2Recruited 4723 BA-24 usual care7 dropout BA, 2 usual careFinal clinical measures 16 BA, 22 usual care High level of baseline severity BDI-II-35.32 (SD 9.50) Long duration 3.67 years (SD 7.2 years)Randomisation produced equal groups

Clinical ResultsBA superior on all measures with large effect and more recovery BDI-II difference post in favour of BACompleters −15.65 (95% CI −6.90 to −24.41) SMD −1.15 (−1.85

to −0.45) ITT−15.78 in favour of BA (95% CI −24.55 to −7.02, p= 0.001)WASA in favour of BACompleters −11.56 (−4.79 to−18.33) p=0.001 SMD −1.14 (−1.84

to −0.45) ITT−11.12 in favour of BA (95% CI −17.53 to −4.70, p= 0.001) Satisfaction BA: 29 on 32 point scale, Better than usual care

p=0.001Strong adherence on checklist

Comparison to studies with ‘expert’ therapists

Ekers, Dawson and Bailey Journal of Psychiatric and Mental Health Nursing 2013, 20, 186–192

Economic Analysis

Ekers D, Godfrey C, Gilbody S, Parrott S, Richards D, Hammond D and Hayes A. (In

Press BJ Psych)

-£2,000

-£1,500

-£1,000

-£500

£0

£500

£1,000

£1,500

£2,000

-0.15 -0.10 -0.05 0.00 0.05 0.10 0.15

Cost Difference

Effe

ct D

iffer

ence

Cost more/less effective

Cost less/less effective Cost less/more effective

Cost more/more effective

ICER based upon 1000 bootstrapped replications = £5,006 £5,756

97% likelihood that the additional cost of BA over usual care per QALY gained is less than £20,000,

Small Study - Big LimitationsSmall sample2 therapistsNo follow up

But helped us in looking at the proof of principle

SummaryBA for some time has been viewed as an effective

intervention (as effective as CBT)Results appear to maintain when delivered by non

specialists with appt training (parsimony-dissemination as per Jacobson 1996?)

Cost effectiveness appears very promising with BA offering well below NICE threshold cost per QALY even using conservative estimate

Large scale replication needed to examine results with more therapists and participants

CURRENT RESEARCH

Behavioural Therapy for depression. A meta-analysis update Ekers, Webster, Cuijpers, Von Straten, Richards, Gilbody

29 studies-36 comparisons BA vs. controls (1387 participants)Effect size maintains at the large level vs. control−0.72 (95% CI −0.88 to −0.55 p<0.001 NNT 2.5)

Vs. medication results 4 studies, 5 comparisons 288 participants−0.37 (95% CI −0.74 to −0.05 p 0.05 NNT 4.9)

Did any subgroups of studies look any differentOnly control group type had any strong association/placebo controls=reduced effect sizeLevel of therapistNon specialist BA 6 studies SMD −0.66 −0.90 to −0.43 p< 0.001 I2 25.60%Specialist BA 23 studies SMD −0.74 −0.95 to −0.54 p< 0.001 I2 47.27%Complexity of BA- Simple BA 19 studies (SMD −0.72 −0.92 to −0.51 p< 0.001 I2 58.01%)Complex BA in 10 studies (SMD −0.73 −1.01 to −0.44 p< 0.001 I2 36.49%)

What we seeBA is an effective treatment for depression

Effect sizes appear consistent as the number of studies slowly grow

Subgroup analysis do not show strong association supporting increasing complexity or higher trained therapists

We do however need larger studies to provide more definitive examination of this

COBRA(Cost and Outcome of BehaviouRal Activation)

A Randomised Controlled Trial of Behavioural Activation versus Cognitive Therapy for Depression

Multi-site Research Team

MDC and PCMD, Exeter Richards (CI), Farrand, Kuyken, O’Mahen,

Taylor, Watkins, Wright

York Gilbody, McMillan

Durham Ekers

Depression Alliance O’Neill

IOP– Byford

TSC Tylee

DMeC Cape, Lovell

CBT Assessors OCTC

BA Assessor Martell

Advisors Hollon, Martell, Dimidjian

DesignCOBRA is a two-arm Phase III, non-inferiority randomised controlled trial of a psychological intervention: Behavioural Activation (BA).The COBRA programme of research seeks to answer two interlinked questions:

What is the clinical effectiveness of BA compared to CBT for depressed adults in terms of depression treatment response measured by the PHQ9 at six, 12 and 18 months?

What is the cost-effectiveness of BA compared to CBT at 12 and 18 months?

We hypothesize that BA is non-inferior compared to CBT in reducing depression severity but that BA will be less costly and thus more cost-effective than CBT.In addition, we will undertake a secondary process evaluation to investigate the moderating, mediating and procedural factors in BA and CBT which influence outcome.

InterventionsBA (Non specialist Band 5)

CBT (specialist band 7 therapist)

Both active psychological treatments which have previously demonstrated positive effects for people with depression, and are recommended by NICE guidelines for the treatment of depression

In both arms of the study, 220 (440 total) participants will receive a maximum of 20 sessions over 16 weeks with the option of four additional booster sessions Sessions will be face to face, of one-hour duration maximum

CASPER & CASPER PlusChief Investigator Prof Simon Gilbody University of YorkLocal Principal Investigator-Site lead Dr David Ekers

Funded by NIHR HTA programmeWhat is the effectiveness and cost-effectiveness of brief

interventions to prevent the progression of sub-clinical depression in older people?’

CASPER- Sub Threshold Depression- recruitment completed-705 people randomised into Collaborative Care/usual care-recruitment completeCASPER plus- Older adults with depression 450 people to be randomised collaborative care/usual care- recruitment until June 2014

Intervention/follow upCollaborative care, delivered by case manager/own home or over phone10 sessions Patient engagement & educationCo-ordination of care/Medication managementBrief psychosocial interventions/Behavioural activationEnsure follow up/Monitor outcomes ‘Stepping-up’ as needed

Manual guided intervention – adapted from previous research12 month follow up of clinical and cost outcomes

One of largest RCTs of psychological support for older adults internationally

Example how BA may lend itself to collaborative care structures across health settings

SummaryBA looks to be an effective and simple intervention for

depression

Its simplicity may make it suitable for wide and efficient dissemination but more research is ongoing

Whilst psychotherapies for depression have the same effectiveness the search for improved reach may result in greater clinical/population benefit-this is where BA may have greatest advantage.

Behavioural Activation for Depression

David Ekers PhD, MSc, ENB 650 (CBT), RMN

David.ekers@durham.ac.uk