Optimizing Management of HIV: Integrated Treatment for Depression and Adherence
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Optimizing Management of HIV: Integrated Treatment for
Depression and Adherence
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Focus area: Increasing
Adherence to HIV Medications
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Life-Steps*• Psychoeducation/Motivation for
Adherence• Getting to Appointments• Communication with Treatment
Team• Coping with Side Effects• Obtaining Medications• Formulating a Daily Medication
Schedule
*Safren SA, Otto MW, Worth J. Life-Steps: Applying cognitive behavioral therapy to HIV medication adherence. Cogn Behav Pract. 1999;6:332-341.
• Storing Medications• Cue Control Strategies for Taking
Medication• Guided Imagery/Rehearsal• Handling Slips in Adherence• Review
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Depression is Highly Prevalent
in Patients with HIV• Rates of depression among persons with HIV infection range from 20-37% in epidemiological and sample studies (Atkinson & Grant, 1994; Bing et al., 2001; Cruess et al., 2003)
• Depression is 2x more prevalent in patients with HIV than patients without HIV (Cielsa & Roberts, 2001)
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Why Target Depression in an HIV Medication Adherence
Study?• Depression is associated with poor
medication adherence and accelerated disease progression (Pence et al., 2007; Safren et al., 2001)
• Depressed patients are 3x more likely to be non-adherent to medical treatment regimens than non-depressed patients (DiMatteo et al., 2000)
• Depression may moderate the ability of a patient to benefit from health-behavior interventions that do not address depression
• HIV adherence interventions for individuals with mental health disorders are lacking (Amico et al., 2006; Simoni et al., 2006)
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CBT for Adherence and Depression (CBT-AD) in HIV
• Life-Steps (1 session)• Psychoeducation/Motivational
Interviewing about CBT for Depression (1 session)
• Behavioral Activation/Activity Scheduling (1 session)
• Adaptive thinking (3 sessions)
Each session builds on the previous session and each session integrates adherence skills.
• Problem Solving (3 sessions)
• Relaxation/Diaphragmatic Breathing (1 session)
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Life-Steps*• Psychoeducation/Motivation for
Adherence• Getting to Appointments• Communication with Treatment
Team• Coping with Side Effects• Obtaining Medications• Formulating a Daily Medication
Schedule
*Safren SA, Otto MW, Worth J. Life-Steps: Applying cognitive behavioral therapy to HIV medication adherence. Cogn Behav Pract. 1999;6:332-341.
• Storing Medications• Cue Control Strategies for Taking
Medication• Guided Imagery/Rehearsal• Handling Slips in Adherence• Review
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Play Video
Electronic Life Steps WorkbookCasey Claborn, M.S. Thad R. Leffingwell,. Ph.D.
Department of PsychologyOklahoma State University
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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)
CBT-AD: Study 1
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>300 phone screens, 118 baseline evaluations
45 patients randomized (3 dropped post-randomization)
42 participants completed baseline and T229% AA, 15% Latino/Hispanic, 7% other; mean age = 44 64% had at least one additional DSM-IV diagnosis38% had two additional DSM-IV diagnoses
Most 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%)
CBT-AD Study 1: Sample Issues
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Study 1 Integrating the Treatment of Depression with Adherence Counseling
in HIV†
• 2 Arm, cross-over design comparing 12 sessions of CBT-AD to a single session of adherence counseling
• Participants: 45 randomized, 42 completers with DSM-IV diagnosable depression
• CBT-AD resulted in improved adherence (MEMS=pill cap) and depression at 3 months, and gains were maintained at 6 and 12 months.
• Those who “crossed over” caught up after completing the full intervention
HAM-D outcomes
0
5
10
15
20
25
BASE T2
†Safren SA, O’Cleirigh CO, Tan JY, et al. A randomized controlled trial of cognitive behavioral therapy for adherence and depression (CBT-AD) in HIV-infected individuals. Health Psychol. 2009;28:1-10.
F(1,42) = 6.32, p < .02, Cohen d = .82
MEMS Adherence outcomes
0
25
50
75
100
BASELINE T2CBT ETAU
F(1,42) = 21.94, p< .0001, Effect size (Cohen d) = 1.0
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CBT-AD Study 2 Method• CBT for Medication Adherence and
Depression in HIV+ Methadone Patients o Participants recruited from methadone clinics and
community in Massachusetts and Rhode Islando 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
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MeasuresClinician-
administered:• Mini International
Neuropsychiatric Interview (MINI; Sheehan et al., 1998)
• Montgomery-Asberg Depression Rating Scale (MADRS; Montgomery & Asberg, 1979)
• Clinical Global Impression (CGI; NIMH, 1985) for Depression and Substance Abuse Severity (1 = “Not at all ill” to 7 = “Extremely ill)”
Self-report:• Beck Depression
Inventory- Short Form (BDI-SF; Beck et al., 1961, 1988)
Biological Heath:• HIV plasma RNA viral
load• CD4+ lymphocyte count
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MeasuresAdherence:• Electronic pill-cap
(Medication Event Monitoring System, MEMS; AARDEX)
• Monitored most frequently dosed or most difficult to remember
medication • Non-adherence defined as
missed dose or dose late by more than 2 hours
• Data corrected for pocketed doses, etc.
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3 Month Assessment (n = 41)
Baseline Diagnostic Assessment (n = 154)
Baseline Independent Assessment
Life-Steps (n = 89) and Randomization
Excluded (n = 65)Did not meet inclusion criteria (n = 37)Dropped out (n = 28)
CBT-AD(n = 44)
CBT-AD(n = 45)
3 Month Assessment (n = 40)
6 Month Assessment (n = 35)
6 Month Assessment (n = 38)
12 Month Assessment (n = 36)
12 Month Assessment (n = 30)
Study Design &Participant Flow Diagram
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Participants• 89 HIV-infected adults with a diagnosis of
depression in treatment for injection drug use were randomized– Sex and Age
• 61% men, mean age = 47 (SD = 7)– Substance Abuse Treatment
• 70% in methadone maintenance therapy, 6% in suboxone therapy, 24% in group or individual substance abuse therapy
– Employment• 66% on disability, 4% full-time work or school
– Race• 49% White, 32% Black
– Ethnicity• 25% self-identified as Hispanic or Latino
– Sexual Orientation• 79% exclusively heterosexual
– Disease Characteristics at Baseline• Mean CD4 = 449 (SD = 265), mean viral load = 3669 (SD
= 13808)– Exceptionally high psychiatric comorbidity
• 61% one additional DSM-IV diagnosis, 41% 2+There were no significant differences between conditions for any of these variables.
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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 = .047).
Acute MEMS Adherence Outcomes
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CBT-AD had Better Acute Depression Outcomes:
Longitudinal (HLM) Analysis of BDI-13
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).
Acute BDI Outcomes
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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
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Follow-up Adherence Gains in CBT-AD were not maintained after
treatment endedFollow Up MEMS Adherence
Outcomes
50
55
60
65
70
75
80
3 Month 6 Month 12 Month
CBT
ETAU
Significant decrease in medication adherence across the follow-up time period (γslope = -0.294, t (79) = -3.24, p < .01); and differences in adherence change over the follow up time period did not differ significantly between the conditions (γslope = 0.13, t (77) = -0.77, p = .44)
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Depression Gains Were Maintained After Treatment
Ended• The significant decreases in MADRS scores for
the CBT-AD condition and non-significant decrease in the ETAU condition were maintained during the follow up period – A trend for a continuing decrease in depression
symptoms for the whole sample (γslope = -0.62, t (79) = -1.78, p = .08)
• The significant decreases in CGI scores for the CBT-AD condition and non-significant decrease in the ETAU condition were maintained during the follow up period– Continuing decrease in depression symptoms for the
whole sample (γslope = -0.10, t (79) = -2.29, p = .03)
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Viral Load Did Not Differ by Study Condition at Follow Up: Repeated Measures (GLM) & Longitudinal
(HLM) Analysis• There were no significant differences
between the ETAU and CBT-AD conditions in HIV viral loadlog 10 at post treatment (F (1,87) = 0.168, p = .85)
• After controlling for resistance and HIV viral load at baseline, there was no significant change in viral loadlog 10 during the course of the study (γslope = -0.0015, t (84) = -0.801, p = .43) or significant differences between conditions (γslope = -.0016, t (81) = -0.450, p = .65) over the course of the study
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CD4, However, Did Differ by Study Condition at Follow Up: Repeated Measures (GLM) & Longitudinal
(HLM) Analysis• There were no significant differences
between the ETAU and CBT-AD conditions in HIV viral loadlog 10 at post treatment (F (1,87) = 0.168, p = .85)
• After controlling for resistance and HIV viral load at baseline, there was no significant change in viral loadlog 10 during the course of the study (γslope = -0.590, t (79) = -1.08, p = .29).
• BUT there was a or significant differences between conditions (γslope = 2.09, t (76) = 2.20, p = .03) over the course of the study. This was a 61.2 DC4 cell increase compared to a 22.4 CD4 cell decrease
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Conclusions• CBT-AD had acute and significant effects
on both adherence and depression during the intervention for triply diagnosed HIV-infected IDU
• Post-intervention discontinuation, adherence rates decreased but improvements in depression remained relatively stable
• Individuals struggling with multiple comorbidities, such as substance abuse and depression, may benefit from continued adherence counseling even after depression improves
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• Integrated Life Steps Treatment Manuals
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Thank YouCollaborators:• Dr. Kenneth Mayer• Dr. Roger Weiss• Dr. Deb Herman• Dr. Nafisseh
Soroudi• Dr. Robert Malow• Dr. Christina
Psaros• Dr. Andres Bedoya• Dr. Jonathan Lerner• Dr. Jeffrey
Gonzalez• Dr. Joseph Greer• Dr. Robert Knauz• Norma Reppucci• Joan Cremins• Susan Adams• Betty Bredin• Cal Dyer
Research Coordinators:
• Giselle Perez• Susie Michelson• Pamela Handelsman• Luis Serpa• Laura Reilly• Jared Israel• Jackie Bullis
NIDA Funding: R01 DA018603
The Participants!The Substance Abuse Treatment Clinics
Bay CoveHabit OpCoCSAC
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Questions?