toronto i-ii 8:30 pm a depression intervention to improve adherence
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Toronto I-II 8:30 pm A depression intervention to improve adherence . Conall O’Cleirigh Associate Director of Behavioral Medicine at Massachusetts General Hospital, Assistant Professor at Harvard Medical School, and Research Scientist at the Fenway Institute, Boston. - PowerPoint PPT PresentationTRANSCRIPT
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Toronto I-II 8:30 pm
A depression intervention to improve adherence
Conall O’CleirighAssociate Director of Behavioral Medicine at Massachusetts General Hospital, Assistant Professor at Harvard Medical School, and Research Scientist at the Fenway Institute, Boston
Moderator: Trevor A. HartAssociate Professor in the Department of Psychology at Ryerson University and Adjunct Faculty at the Dalla Lana School of Public Health at the University of Toronto
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Addressing Depression in Interventions with HIV-Infected Populations
Conall O’Cleirigh, Ph.D.
Assistant Professor, Harvard Medical SchoolAssociate Director, Behavioral Medicine, MGH
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“Minimal” Interventions for HIV Medication Adherence (Interventions that did not address Depression) Conducted at MGH and Fenway Health
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Life-Steps
1: Psychoeducation, Motivation for Adherence2. Getting to Appointments3. Communication with Treatment Provider4. Side Effects5. Obtaining Medications6. Schedule7. Storage of Medications8. Cue Control Strategies9. Guided Imagery (Rehearsal)10. Slips11. Review and Phone Follow-Up
(Safren et al., 1999; Cognitive and Behavioral Practice)
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Life-Steps: Self reported adherence
Analysis of those with baseline adherence problems
Week 0 Week 2 Week 12
Medication Monitoring 84% 90% 93%
(n=26) (n=25)
Life- 74% 95% 94%Steps (n=30) (n=28)
Week 2: Significant Interaction (F(1,54) = 4.41, p <.05) favoring improvement for the Life-Steps Condition (eta sq = .075).Week 12: Significant Improvement in Both Groups with time (F(1,54) = 10.64, p <.01); interaction not significant
Safren et al., 2001; Behaviour Research and Therapy
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Correlations with self-reported adherence
Safren et al., 2001, Behaviour Research and Therapy; 2002, Psychosomatics
Predictor (N=84) R, p’s <.01
Depression (M=14.10, SD 8.77) -.39Satisfaction with Social Support (M=4.4, SD 1.5) .38, Punishment Beliefs About HIV Infection -.34
Adherence Self-Efficacy .34
• Regression analysis: Depression the only unique significant predictor (p < .001).
• 75% had BDI scores greater than 10, 40% had scores over 20• Depression associated with intervention outcome
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Amico et al: Meta-analysis of adherence intervention trials from 1996 to 2004 (25 studies)
• Small effect d=.35, but varied considerably across studies
• Effect sizes did not vary by sample design, sample demographics, articulation of a theory, intensity of intervention, duration of intervention exposure, or measurement strategy
• Effect sizes varied by baseline adherence: Those with known or anticipated adherence problems had medium effects (d=0.62); Those that did not target participants with adherence problems had smaller effects (d = 0.19)
• Improvements did not decay across time
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Simoni et al: Meta-analysis – 19 RCTs 2006 presentation of results – added 5 RCTs from Amico
• Focus exclusively on RCTs• Those who got interventions were 1.5 times more
likely to attain 95% adherence than controls• Those who got interventions were 1.25 times
more likely to attain undetectable viral loads than controls
• Not due to any one study (sensitivity analyses)• None of the stratification variables were
significant (i.e. short versus long, group vs individual, trained professionals versus clinic staff, multiple component versus single session, use of external reminder or not)
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Consideration of Depression and Self-Care in HIV
• Depression is associated with worse adherence in medical illness in HIV (Gonzalez et al., meta analysis submitted)
• 85-95% adherence to ART is required to maximize suppression of HIV viral load
• Depressed mood may be associated with difficulties in reducing HIV transmission risk behavior
General Population
HIV-Infected
Individuals
7% 1 36% 3
Estimates of depression
1. Kessler et al., 2005; Archives of General Psychiatry2. Geffken et al., 1998; Psychiatric Clinics of North America3. Krishnan et al., 2002; Biological Psychiatry, Bing et al., 2005
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Information-motivation-behavioral skills model
Information
Behavioral Skills
Motivation
Adherence
Depression / Anxiety, mental health dx
Fisher et al, Health Psychology, 2006.
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Information-motivation-behavioral skills model
Information
Behavioral Skills
Motivation
Adherence
Depression / anxiety, other mental health diagnosis
Fisher et al, Health Psychology, 2006.
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Self efficacy
Condom Use
Pleasure reduction
Disease prevention
Social Models
Depression, anxiety, mental health problems
Wulfert, Safren, et al., 1999; Journal of Applied Social Psychology
Example Model of Health Behavior Change: Self-efficacy Model for Condom Use
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Self efficacy
Condom Use
Pleasure reduction
Disease prevention
Social Models
Depression, anxiety, mental health problems
Social Cognitive Model
Wulfert, Safren, et al., 1999; Journal of Applied Social Psychology
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Proportion of sexual
transmission risk behavior
Negative expectancy about
condom useCondom use self-efficacy
(-)
(-)
(+)
Socialmodels of
condom use
Proposed Model
• 403 (of 503 total) sexually active MSM in care at Fenway Community Health
• Screening for one of two secondary prevention trials (NIMH, HRSA) between 2004-2007
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R2 for Proportion of Sexual TRB: Depression-negative (n=356)=20.3%, Depression-positive (n=47)=7.5%.Model fit indices: χ2(36)=30.55, p=.73, CFI=1.00, RMSEA<.01, SRMR=.05
tp<.10; *p<.05; **p<.01; ^ fixed to 1 to set metric for latent variable
Proportion of sexual
transmission risk behavior
Negative expectancy
about condom use
Condom use self-efficacy
Socialmodels of
condom use
SE1
SE3
SE2
SE4
.23**/.23**
.18**/.15**
-.32**/
n.s.
.28**/.28**
-.34**/-.34**
.87 ^/93 ^
.64**/.58**
.93**/.93**
.81** /.70**
-.10 t/
n.s.
Predicting TRB in Depressed and Not Depressed HIV-Infected MSM
Safren et al., 2009, Health Psychology
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R2 for Proportion of Sexual TRB (n=356)=20.3%
tp<.10; *p<.05; **p<.01; ^ fixed to 1 to set metric for latent variable
Proportion of sexual
transmission risk behavior
Negative expectancy
about condom use
Condom use self-efficacy
Socialmodels of
condom use
SE1
SE3
SE2
SE4
.23
.18**
-.32**
.28**
-.34**
.87^
.64**
.93**
.81**
-.10 t
Path model for those who did not screen in for major depressive disorder
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R2 for Proportion of Sexual TRB (n=47)=7.5%.
*p<.05; **p<.01; ^ fixed to 1 to set metric for latent variable
Proportion of sexual
transmission risk behavior
Negative expectancy
about condom use
Condom use self-efficacy
Socialmodels of
condom use
SE1
SE3
SE2
SE4
.23**
.15**
.28**
-.34**
.93^
.58**
.93**
.70**
Participants who met screen-in criteria for MDD
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Major Depressive Episode (SIG-E-CAPS)
In addition to persistent sadness more days than not• Sleep• Interest – loss of (can substitute sadness as a
required symptom)• Guilt/worthlessnes• Energy• Concentration• Appetite • Psychomotor retardation• Suicidality**need 5 symptoms, one must be sadness or loss of
interest
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CBT-AD
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Psychoeducation: CBT Conceptualization ofDepression
Cognitive
PhysiologicalBehavioral
Negative Automatic Thoughts and Beliefs concerning self, the past, present, future.
Decrease in pleasurable activities, motivation, decrease in problem solving
Sleep, concentration, appetite, fatigue, restlessness
Cognitive Restructuring
Behavioral Activation
Relaxation Training
Problem Solving
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CBT-AD Overview
Modules: 12 sessions, each 50 minutes long
1. Psychoeducation and Motivation………... 1 session
2. Adherence Training / Life-Steps…………. 1 session
3. Activity Scheduling…………………………2 sessions
4. Cognitive Restructuring…………………... 4 sessions
5. Problem Solving……………………………2 sessions
6. Relaxation Training……………………….. 1 session
7. Maintenance & Relapse Prevention…….. 1 session
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1. Estimation of effect size2. Is actively treating depression necessary to
increase adherence: Comparison of full intervention to minimal intervention
3. Continue acceptability and feasibility testing4. Circumscribed inclusion criteria – maximize
potential for effect and for internal validity
First Randomized Controlled Trial(NIMH R21 06660)
Safren, O’Cleirigh et al., 2009 – Health Psychology
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Design
1. Two arm RCT (full CBT versus LifeSteps and provider letter)
2. Cross over: those who still met initial inclusion criteria could cross over from comparison group after post
3. Outcome: Adherence (MEMs), Depression (Independent assessor, self-report)
Safren, O’Cleirigh et al., 2009 – Health Psychology
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Participants
>300 phone screens, 118 baseline evaluations45 patients randomized (3 dropped post-randomization)42 participants (29% AA, 15% Latino/Hispanic, 7% other;
mean age = 44) completed baseline and T227 (64%) had at least one additional DSM-IV diagnosis16 (38%) had two additional DSM-IV diagnosesMost frequent comorbid diagnoses (includes participants with
>1 comorbid diagnoses):PTSD 13 (31%) ADHD 2 (5%)
Social Phobia 9 (21%) OCD 2 (5%) Panic disorder 11 (26%) GAD 2 (5%)
Safren, O’Cleirigh et al., 2009 – Health Psychology
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Outcome of CBT-AD
MEMS outcomes, ITT
0
25
50
75
100
BASELINE T2CBT ETAU
HAM-D outcomes, ITT
0
5
10
15
20
25
BASE T2
CBT ETAU
CGI outcomes, ITT
0
1
2
3
4
5
BASE T2
CBT ETAU
F(1,42) = 21.94, p< .0001, Cohen d = 1.0 F(1,42) = 6.32, p < .02, Cohen d = .82 F(1,42) = 9.68, p < .01, Cohen d = .91
Significant acute improvement in adherence (MEMS) and depression in intent-to-treat analyses
Similar pattern of results for completer analysesThose who “crossed-over” caught up Intervention-associated improvements were generally maintained at 6
and 12 months
54%
88%
54%
62%16.8
13.3
20.4
18.1 3.7
2.83.8
4.0
Safren, O’Cleirigh et al., 2009 – Health Psychology
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Those who crossed over “caught up” MEMs
Adherence cross over outcomes, ITT
0
20
40
60
80
100
BASE T2 T3
CBT ETAU
2X3 ANOVA: significant interaction F(2,31) = 11.512, p < .0001 T2 to T3 2x2 ANOVA significant interaction: (F(1,32) = 23.461, p< .0001) T1 to T3 ANOVA: Main effects for time (F(1,32) = 43.206, p < .0001).
Safren, O’Cleirigh et al., 2009 – Health Psychology
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HAM-D cross-over outcomes, ITT
0
5
10
15
20
25
BASE T2 T3CBT ETAU
Those who crossed over “caught up” with improved depression
CGI cross-over outcomes, ITT
00.5
11.5
22.5
33.5
44.5
BASE T2 T3
2X3 ANOVA: significant interaction F(2,31) = 8.361, p < .01
T2 to T3 2x2 ANOVA significant interaction: (F(1,32) = 9.237, p < .01
T1 to T3 ANOVA: Main effects for time F(1,32) = 28.637, p < .0001
2X3 ANOVA: significant interaction F(2,31) = 7.299, p< .01
T2 to T3 2x2 ANOVA significant interaction: F(1,32) = 9.848, p < .01
T1 to T3 ANOVA: Main effects for time F(1,32) = 33.767, p < .0001
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Flexibility in delivering the intervention (delivered by doctoral or internship level psychologists)
Therapist adherence – to general principals of CBT and the manual versus every session following the outline
-Flexibility of adapting the modules -Flexibility in sequence of modules-Flexibility in time spent on modules-Bring current problems back to CBT skills for
adherence and depression
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o Participants (N=89) recruited from methadone clinics and community in Massachusetts and Rhode Island
o Randomized to either ETAU or CBT-AD o Stratified by sex, depression severity (current MDD
or residual symptoms only), and adherence (baseline MEMS adherence above or below 80%)
• Inclusion Criteria:o HIV-positiveo Prescribed antiretroviral therapyo History of injection drug use and
enrollment in a drug abuse treatment program for at least one month
o Current or subsyndromal depression
o Between the ages of 18 and 65
CBT for Medication Adherence and Depression in HIV+ Methadone Patients
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CBT-AD had greater acute adherence outcomes: Longitudinal (HLM) Analysis of MEMS
65
70
75
80
85ETAUCBT-AD
Improvement in the CBT-AD condition was greater than in the ETAU condition (γslope = 0.717, t (87) = 2.01, p < .05).
Acute MEMS Adherence Outcomes
Safren, O’Cleirigh et al., 2012 – JCCP
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CBT Had Better Clinician-Assessed Depression Outcomes: Analysis of CGI & MADRS
2
3
4
5
Pre Randomization Post Treatment
Control
CBT-AD
15
17
19
21
23
25
27
29
31
Pre Randomization Post Treatment
ControlCBT-AD
F = 6.52, df (1,79), p < .01
Post Treatment MADRS Outcomes
Post Treatment CGI Outcomes
F = 14.77, df = (1,79), p < .001
Safren, O’Cleirigh et al., 2012 – JCCP
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Follow-up
• Adherence: Gains were not maintained – no difference between intervention and control over the 3 and 9 month follow-up
• HIV Viral load: no difference across conditions
• Depression: Gains were maintained across all indicators of depression
• CD4: Significant differences between conditions (γslope = 2.09, t (76) = 2.20, p = .03) over the course of the study. • Intervention group: 61.2 CD4 cell increase • Comparison group: 22.4 CD4 cell decrease
Safren, O’Cleirigh et al., 2012 – JCCP
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CBT-AD/ETAU ART Adherence (MEMS)
Depression
Do Reductions in Depression Mediate Treatment Related Reductions in Adherence
.
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CBT-AD/ETAU ART Adherence (MEMS)
CBT-ADIntegrated Treatment for Depression and Adherence
65
70
75
80
85ETAUCBT-AD
Adherence Outcomes
Improvement in the CBT-AD condition was significantly greater than in the ETAU condition (γslope = 0.717, t (87) = 2.01, p < .05).
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CBT-AD/ETAU
Depression
CBT-ADIntegrated Treatment for Depression and Adherence
68
10121416 ETAU
CBT-AD
Trajectory of improvement in self-reported depression was greater for the CBT-AD condition than the ETAU condition (γslope = -0.30, t (87) = -2.60, p = .01).
Depression Outcomes
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CBT-AD/ETAU ART Adherence (MEMS)
Depression
Support for Integrated Treatment Model
(γslope =0.48, t(86) = 1.35, p=.18)
(γslope=0.717, t(87) = 2.01, p<.05)
(γslope = 0.032, t (86) = 1.98, p =.05),
(F(1, 79 = 6.52, p <.01).
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Baseline Assessment
Screen out/ Drop out
Life-Steps (Weekly Visit One)
CBT-ADISP-ADTreatment as Usual
11 Treatment Visits 11 Treatment Visits5 Non-Treatment Visits
4 month
8 month
12 month
Pre-consent Screen
Current work - Project “TRIAD”
NIMH R-01 MH084757
NIMH funded efficacy trial (PI: Safren) R01MH084757-05
3 arm study (2:2:1 randomization)• Life-Steps plus provider letter• CBT-AD• Information/supportive
psychotherapy• Large N (240; 80
randomized per site)
• 217 (90%) completers
• 3 site study (MGH, Brown, Fenway)
• Wide inclusion criteria
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Lessons Learned from Integrating Treatment of Medical (Self-Care) and Psychiatric Problems
Change is hard Exit interviews: high patient
acceptance / appreciation But can use CBT techniques to
improve adherence, even in the context of mental health comorbidity
Which can improve medical outcomes (e.g. HIV outcomes)
• Need to analyze cost and cost-effectiveness
• Implications for “population based medicine” and integrated care
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What’s next?10:00 a.m Special Session
Mindfulness Workshop
(Johnson)
10:00 a.m Guided Poster TourCare in Focus
(Foyer)