title: Cognitive behavioural therapy for adherence and depression in patients with HIV: a three-arm randomised controlled trial.
abstract: Depression is highly prevalent in people with HIV and has consistently been associated with poor antiretroviral therapy (ART) adherence. Integrating cognitive behavioural therapy (CBT) for depression with adherence counselling using the Life-Steps approach (CBT-AD) has an emerging evidence base. The aim of this study was to test the efficacy of CBT-AD.
  
  
  
  In this three-arm randomised controlled trial in HIV-positive adults with depression, we compared CBT-AD with information and supportive psychotherapy plus adherence counselling using the Life-Steps approach (ISP-AD), and with enhanced treatment as usual (ETAU) including Life-Steps adherence counselling only. Participants were recruited from three sites in New England, USA (two hospital settings and one community health centre). Patients were randomly assigned (2:2:1) to receive CBT-AD (one Life-Steps session plus 11 weekly integrated sessions lasting up to 1 h each), ISP-AD (one Life-Steps session plus 11 weekly integrated sessions lasting up to 1 h each), or ETAU (one Life-Steps session and five assessment visits roughly every 2 weeks), randomisation was done with allocation software, in pairs, and stratified by three variables: study site, whether or not participants had been prescribed antidepressant medication, and whether or not participants had a history of injection drug use. The primary outcome was ART adherence at the end of treatment (4 month assessment) assessed via electronic pill caps (Medication Event Monitoring System [MEMS]) with correction for pocketed doses, analysed by intention to treat.
  
  
  
  Patients were recruited from Feb 26, 2009, to June 21, 2012. Patients who were assigned to CBT-AD (94 randomly assigned, 83 completed assessment) had greater improvements in adherence (estimated difference 1·00 percentage point per visit, 95% CI 0·34 to 1·66, p=0·003) and depression (Center for Epidemiological Studies depression [CESD] score estimated difference -0·41, -0·66 to -0·16, p=0·001; Montgomery-Asberg depression rating scale [MADRS] score -4·69, -8·09 to -1·28, p=0·007; clinical global impression [CGI] score -0·66, -1·11 to -0·21, p=0·005) than did patients who had ETAU (49 assigned, 46 completed assessment) after treatment (4 months). No significant differences in adherence were noted between CBT-AD and ISP-AD (97 assigned, 87 completed assessment). No study-related adverse events were reported.
  
  
  
  Integrating evidenced-based treatment for depression with evidenced-based adherence counselling is helpful for individuals living with HIV/AIDS and depression. Future efforts should examine how to best disseminate effective psychosocial depression treatments such as CBT-AD to people living with HIV/AIDS and examine the cost-effectiveness of such approaches.
  
  
  
  National Institute of Mental Health, National Institute of Allergy and Infectious Diseases.
authors.affiliation: Department of Psychology, University of Miami, Miami, FL, USA; Behavioral Medicine, Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Department of Psychiatry, Harvard Medical School, Boston, MA, USA; The Fenway Institute at Fenway Health, Boston, MA, USA. Electronic address: ssafren@miami.edu.
authors.forename: Steven A
authors.initials: SA
authors.lastname: Safren
authors.affiliation: Behavioral Medicine, Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Department of Psychiatry, Harvard Medical School, Boston, MA, USA.
authors.forename: C Andres
authors.initials: CA
authors.lastname: Bedoya
authors.affiliation: Behavioral Medicine, Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Department of Psychiatry, Harvard Medical School, Boston, MA, USA; The Fenway Institute at Fenway Health, Boston, MA, USA.
authors.forename: Conall
authors.initials: C
authors.lastname: O'Cleirigh
authors.affiliation: The Fenway Institute at Fenway Health, Boston, MA, USA; Department of Behavioral & Social Health Sciences and Epidemiology, School of Public Health, Brown University, Providence, RI, USA; Department of Psychiatry & Human Behavior, Alpert Medical School, Brown University, Providence, RI, USA; Institute for Community Health Promotion, Brown University, Providence, RI, USA.
authors.forename: Katie B
authors.initials: KB
authors.lastname: Biello
authors.affiliation: Immunology and Infectious Diseases, Brown University, Providence, RI, USA; The Miriam Hospital, Providence, RI, USA.
authors.forename: Megan M
authors.initials: MM
authors.lastname: Pinkston
authors.affiliation: Department of Health Law, Policy & Management, Boston University School of Public Health, Boston, MA, USA.
authors.forename: Michael D
authors.initials: MD
authors.lastname: Stein
authors.affiliation: Behavioral Medicine, Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Department of Psychiatry, Harvard Medical School, Boston, MA, USA.
authors.forename: Lara
authors.initials: L
authors.lastname: Traeger
authors.affiliation: The Miriam Hospital, Providence, RI, USA.
authors.forename: Erna
authors.initials: E
authors.lastname: Kojic
authors.affiliation: Division of Infectious Diseases, Massachusetts General Hospital, Boston, MA, USA; Department of Medicine, Harvard Medical School, Boston, MA, USA.
authors.forename: Gregory K
authors.initials: GK
authors.lastname: Robbins
authors.affiliation: Behavioral Medicine, Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Department of Psychiatry, Harvard Medical School, Boston, MA, USA.
authors.forename: Jonathan A
authors.initials: JA
authors.lastname: Lerner
authors.affiliation: Department of Psychiatry and Human Behavior, Butler Hospital, Providence, RI, USA.
authors.forename: Debra S
authors.initials: DS
authors.lastname: Herman
authors.affiliation: The Fenway Institute at Fenway Health, Boston, MA, USA; Department of Behavioral & Social Health Sciences and Epidemiology, School of Public Health, Brown University, Providence, RI, USA; Department of Psychiatry & Human Behavior, Alpert Medical School, Brown University, Providence, RI, USA; Institute for Community Health Promotion, Brown University, Providence, RI, USA; Department of Epidemiology, T H Chan Harvard School of Public Health, Boston, MA, USA.
authors.forename: Matthew J
authors.initials: MJ
authors.lastname: Mimiaga
authors.affiliation: Department of Medicine, Harvard Medical School, Boston, MA, USA; The Fenway Institute at Fenway Health, Boston, MA, USA; Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA, USA.
authors.forename: Kenneth H
authors.initials: KH
authors.lastname: Mayer
mesh_terms: D000293:Adolescent; D000328:Adult; D015928:Cognitive Behavioral Therapy / Q000191:economics; D003362:Cost-Benefit Analysis; D003376:Counseling; D003863:Depression / Q000209:etiology* / Q000628:therapy*; D005260:Female; D015658:HIV Infections / Q000150:complications / Q000188:drug therapy* / Q000523:psychology* / Q000821:virology; D006801:Humans; D008297:Male; D055118:Medication Adherence / Q000523:psychology*; D019057:Quality-Adjusted Life Years; D015819:Substance Abuse, Intravenous / Q000150:complications; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology; D055815:Young Adult