STRATEGIES FOR TREATING DEPRESSION FOR PEOPLE LIVING WITH HIV Conall O’Cleirigh, P.h.D The Fenway Institute Massachusetts General Hospital Harvard Medical School Boston, MA
DEPRESSIO N IS HIG HL Y PREVA L ENT IN PA T IENT S W IT H HIV Rates of depression among persons with HIV • infection range from 20-37% in epidemiological and sample studies (O’Cleirigh et al., 2014; Atkinson & Grant, 1994; Bing et al., 2001; Cruess et al., 2003) thefenwayinstitute.org
DEPRESSIO N A ND A DHERENC E Depressed patients are 3 times greater than non- • depressed patients to be non-adherent to medical treatment recommendations Depressive symptoms are correlated with worse • ART adherence, detectable viral load, and accelerated disease progression Patients with depression are more likely to miss • appointments with their HIV physician (Gonzalez, et al., 2011; Wagner et al., 2011; Dimatteo et al., 2000; Safren et al., 2001, Catz et al., 2000, Patterson et al., 2000; Holzemer et al., 1999) thefenwayinstitute.org
ST RESSO RS REL A T ED T O L IVING W IT H HIV Living with a chronic medical condition • Opportunistic infections • Maintaining health and medication adherence • Economic stress • Employment / disability • Child care • Confidentiality • Comorbidities • thefenwayinstitute.org
SIG NIFIC A NC E O F T REA T ING DEPRESSIO N IN HIV Depression may moderate the ability of a patient to • benefit from health-behavior interventions that do not address depression Efforts to address symptoms of depression may • improve adherence to HIV medications, thus: Improving virologic outcomes • Reducing HIV-related morbidity and mortality rates • Implications for HIV transmission • HIV adherence and engagement in care interventions • for individuals with mental health disorders are lacking (Amico et al., 2006; Simoni et al., 2006) thefenwayinstitute.org
C BT FO R A DHERENC E A ND DEPRESSIO N (C BT - A D) IN HIV Psychoeducation/Motivational • Interviewing about CBT for Depression (1 session) Behavioral Activation/Activity • Scheduling (1 session) • Adaptive Thinking (5 sessions) • Problem Solving (2 sessions) • Relaxation/Diaphragmatic • Breathing (2 sessions) Each session builds on the previous session and each session integrates adherence skills. thefenwayinstitute.org
FIRST ST UDY R2 1 INT EG RA T ING T HE T REA T M ENT O F DEPRESSIO N W IT H A DHERENC E C O UNSELING IN HIV 2 Arm, cross-over design comparing MEMS Adherence outcomes • 100 12 sessions of CBT-AD to a single 75 session of adherence counseling 50 Participants: 45 randomized, 42 • 25 completers with DSM-IV diagnosable 0 depression BASELINE T2 CBT ETAU CBT-AD resulted in improved F(1,42) = 21.94, p< .0001, Effect size (Cohen d) = • 1.0 adherence (MEMS=pill cap) and depression at 3 months, and gains HAM-D outcomes 25 were maintained at 6 and 12 20 months. 15 10 Those who “crossed over” caught up • 5 after completing the full intervention 0 BASE T2 Safren SA, O’Cleirigh CO, Tan JY, et al. A randomized controlled trial of cognitive F(1,42) = 6.32, p < .02, Cohen d = .82 behavioral therapy for adherence and depression (CBT-AD) in HIV-infected individuals. Health Psychol. 2009;28:1-10. thefenwayinstitute.org
LESSO NS LEA RNED - FLEX IBILIT Y IN DELIVERING T HE INT ERVENT IO N (DELIVERED BY DO C T O RA L O R M A ST ERS LEVEL PSYC HO LO G IST S) 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 thefenwayinstitute.org
T A RG ET (SEC O ND ST UDY): C BT FO R M EDIC A T IO N A DHERENC E A ND DEPRESSIO N IN HIV+ IDU 2 arm study (ETAU or CBT-AD) NIDA R01 • Participants (N=89) recruited from substance use treatment • clinics and community in Massachusetts and Rhode Island History (or current) IDU but in SU treatment • 62% at least one additional DSM-IV • diagnosis 42% two or more additional DSM-IV • diagnoses Panic d/o 30% • GAD 18% • Social anxiety d/o 14% • PTSD 10% • Safren, O’Cleirigh, et al., 2012 – JCCP. thefenwayinstitute.org
C BT FO R A DHERENC E A ND DEPRESSIO N IN HIV- INFEC T ED IDU (N= 8 9 ): A C UT E O UT C O M ES 85 31 29 M E M S Adherence (% ) P ast W eek Control 27 CBT-AD 80 25 23 75 21 19 70 17 15 Pre Randomization Post Treatment 65 Depression: Pre-Post Treatment: MEMs-based Adherence: HLM • • analysis of MEMs Weeks 0-10 = Significantly greater greater improvement in improvements in depression in treatment versus control treatment versus control condition [MADRS (F(1,79)=6.52, condition (slope = 0.887, p<.01)] (replicated with clinical t(86)= 2.38, p = .02) global impression Safren, O’Cleirigh et al., 2012 – JCCP [(F(1,79)=14.77, p<.001)] ) thefenwayinstitute.org
Support for Integrated Treatment Model (γ slope =0.48, t(86) = 1.35, p=.18) ART Adherence (MEMS) CBT-AD/ETAU (γ slope =0.717, t(87) = 2.01, p<.05 ) (F(1, 79 = 6.52, p <.01). (γ slope = 0.032, t (86) = 1.98, p =.05) Depression thefenwayinstitute.org
O UT C O M ES A FT ER INT ERVENT IO N DISC O NT INUA T IO N (6 A ND 1 2 M O NT HS) Depression: gains were maintained • MEMS-based adherence: somewhat attenuated • Viral load: No differences across conditions • CD4: the CBT-AD condition had significant improvements in • CD4 cell counts over time compared to ETAU ( γ slope= 2.09, t (76) = 2.20, p = .03) 61.2 CD4 cell increase intervention condition • 22.4 CD4 cell decrease control condition • Safren et al., 2012 – JCCP thefenwayinstitute.org
LESSO NS LEA RNED Depression treatment integrated into substance • use treatment can be effective Flexibility to work in the context of multiple co- • occurring mental health problems Utility of harm reduction approach for ongoing or • substance use relapse Bring current problems back to CBT skills for • adherence and depression thefenwayinstitute.org
T REAT MENT MANUAL thefenwayinstitute.org
T RIA D (T HIRD ST UDY): M ET HO D • CBT for Medication Adherence and Depression in HI V+ Patients Participants recruited from HIV treatment clinics and community in • Massachusetts and Rhode Island Randomized to CBT-AD, ISP-AD, or ETAU • Stratified by current or prior problem with injection drug use, prescribed • medications for the treatment of their depression, and study site • I nclusion Criteria: HIV-positive • Have been prescribed ART for at least 2 • months Have either a current diagnosis of • depression or be prescribed an anti- depressant medication for a depression diagnosis and have at least some residual depressive symptoms (having met full clinical criteria prior to antidepressant initiation). 18 years of age or older • thefenwayinstitute.org
NIMH funded efficacy trial STUDY DESIGN (PI: Safren) R01MH084757-05 NIMH R-01 MH084757 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 Incremental cost effectiveness analysis thefenwayinstitute.org
PARTICIPANTS N = 2 4 0 Age M ( SD) 4 7 .4 ( 8 .4 ) Gender n ( % ) Male 1 6 5 ( 6 8 .7 ) Fem ale 7 5 ( 3 1 .3 ) African Am erican/ Black 6 8 Caucasian/ W hite 1 5 6 Other 3 1 Hispanic/ Latino n ( % ) Yes 2 6 ( 1 0 .8 ) No 2 1 4 ( 8 9 .2 ) Education n ( % ) Partial high school or less 3 3 ( 1 3 .8 ) High school graduate 6 5 ( 2 7 .1 ) Partial college 7 0 ( 2 9 .2 ) College graduate 7 2 ( 3 0 .0 ) On Disability n ( % ) Yes 1 3 9 ( 5 7 .9 ) No 1 0 1 ( 4 2 .1 ) Sexual Orientation n ( % ) Gay/ bisexual 1 3 6 ( 5 6 .9 ) thefenwayinstitute.org
DURING T HE T REA T M ENT PERIO D, C BT - A D A C HIEVED SIG NIFIC A NT LY IM PRO VED M EM S A ND C ESD SC O RES C O M PA RED T O ET A U • Com pared to ETAU, CBT-AD dem onstrated: A significant increase in • adherence over the treatment period (Est.=1.00, 95% CI=0.34, 1.66, p=0.003). Significantly greater • improvement in self-reported depression scores over the treatment period (Est.=-0.41, 95% CI=-0.66, -0.16, p=0.001). MEMS-based adherence and depression (CESD) scores are adjusted through mixed-effects analyses. thefenwayinstitute.org
A T PO ST T REA T M ENT , C BT - A D HA D SIG NIFIC A NT LY LO W ER DEPRESSIO N RA T ING S C O M PA RED T O ET A U Significance CBT-AD ETAU level 2.60 3.26 0.005 CGI (0.13) (0.18) 17.65 22.33 0.007 MADRS (1.03) (1.38) Data are mean (SE). Scores are adjusted for baseline outcome measures and through the use of ANCOVA. Month 4 (when controlling baseline): • CGI (Est.=-0.66, 95% CI=-1.11,-0.21, p=0.005) • MADRS (Est.=-4.69, 95% CI=-8.09,-1.28, • p=0.007) Safren, Bedoya, O’Cleirigh, et al In Press Lancet HIV thefenwayinstitute.org
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