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Optimizing Management of HIV: Integrated Treatment for Depression and Adherence

Optimizing Management of HIV: Integrated Treatment for Depression and Adherence. Focus area: Increasing Adherence to HIV Medications. Life-Steps *. Psychoeducation/Motivation for Adherence Getting to Appointments Communication with Treatment Team Coping with Side Effects

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Optimizing Management of HIV: Integrated Treatment for Depression and Adherence

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  1. Optimizing Management of HIV: Integrated Treatment for Depression and Adherence

  2. Focus area: Increasing Adherence to HIV Medications

  3. Life-Steps* • Psychoeducation/Motivation for Adherence • Getting to Appointments • Communication with Treatment Team • Coping with Side Effects • Obtaining Medications • Formulating a Daily Medication Schedule • Storing Medications • Cue Control Strategies for Taking Medication • Guided Imagery/Rehearsal • Handling Slips in Adherence • Review *Safren SA, Otto MW, Worth J. Life-Steps: Applying cognitive behavioral therapy to HIV medication adherence. Cogn Behav Pract. 1999;6:332-341.

  4. 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)

  5. 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)

  6. 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) • Problem Solving (3 sessions) • Relaxation/Diaphragmatic Breathing (1 session) Each session builds on the previous session and each session integrates adherence skills.

  7. Life-Steps* • Psychoeducation/Motivation for Adherence • Getting to Appointments • Communication with Treatment Team • Coping with Side Effects • Obtaining Medications • Formulating a Daily Medication Schedule • Storing Medications • Cue Control Strategies for Taking Medication • Guided Imagery/Rehearsal • Handling Slips in Adherence • Review *Safren SA, Otto MW, Worth J. Life-Steps: Applying cognitive behavioral therapy to HIV medication adherence. Cogn Behav Pract. 1999;6:332-341.

  8. Electronic Life Steps Workbook Casey Claborn, M.S. Thad R. Leffingwell,. Ph.D. Department of Psychology Oklahoma State University Play Video

  9. CBT-AD: Study 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)

  10. CBT-AD Study 1: Sample Issues >300 phone screens, 118 baseline evaluations 45 patients randomized (3 dropped post-randomization) 42 participants completed baseline and T2 29% AA, 15% Latino/Hispanic, 7% other; mean age = 44 64% had at least one additional DSM-IV diagnosis 38% 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%)

  11. 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 F(1,42) = 21.94, p< .0001, Effect size (Cohen d) = 1.0 F(1,42) = 6.32, p < .02, Cohen d = .82 †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.

  12. CBT-AD Study 2 Method • CBT for Medication Adherence and Depression in HIV+ Methadone Patients • Participants recruited from methadone clinics and community in Massachusetts and Rhode Island • Randomized to either ETAU or CBT-AD • Stratified by sex, depression severity (current MDD or residual symptoms only), and adherence (baseline MEMS adherence above or below 80%) • Inclusion Criteria: • HIV-positive • Prescribed antiretroviral therapy • History of injection drug use and enrollment in a drug abuse treatment program for at least one month • Current or subsyndromal depression • Between the ages of 18 and 65

  13. Clinician-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 Measures

  14. Adherence: Electronic pill-cap (Medication Event Monitoring System, MEMS; AARDEX) Measures • 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.

  15. Study Design &Participant Flow Diagram Baseline Diagnostic Assessment (n = 154) Excluded (n = 65) Did not meet inclusion criteria (n = 37) Dropped out (n = 28) Baseline Independent Assessment Life-Steps (n = 89) and Randomization CBT-AD (n = 44) CBT-AD (n = 45) 3 Month Assessment (n = 41) 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)

  16. 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.

  17. CBT-AD had greater acute adherence outcomes: Longitudinal (HLM) Analysis of MEMS Acute MEMS Adherence Outcomes Improvement in the CBT-AD condition was greater than in the ETAU condition (γslope = 0.717, t (87) = 2.01, p = .047).

  18. CBT-AD had Better Acute Depression Outcomes: Longitudinal (HLM) Analysis of BDI-13 Acute BDI Outcomes 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).

  19. CBT Had Better Clinician-Assessed Depression Outcomes: Analysis of CGI & MADRS Post Treatment CGI Outcomes Post Treatment MADRS Outcomes F = 6.52, df (1,79), p < .01 F = 14.77, df = (1,79), p < .001

  20. Follow-up Adherence Gains in CBT-AD were not maintained after treatment ended Follow Up MEMS Adherence Outcomes 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)

  21. 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)

  22. 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

  23. 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

  24. 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

  25. Integrated Life Steps Treatment Manuals

  26. Thank You Research Coordinators: • Giselle Perez • Susie Michelson • Pamela Handelsman • Luis Serpa • Laura Reilly • Jared Israel • Jackie Bullis Collaborators: • 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 The Participants! The Substance Abuse Treatment Clinics Bay Cove Habit OpCo CSAC NIDA Funding: R01 DA018603

  27. Questions?

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