TY - JOUR
T1 - Cognitive behavioural therapy for adherence and depression in patients with HIV
T2 - a three-arm randomised controlled trial
AU - Safren, Steven A.
AU - Bedoya, C. Andres
AU - O'Cleirigh, Conall
AU - Biello, Katie B.
AU - Pinkston, Megan M.
AU - Stein, Michael D.
AU - Traeger, Lara
AU - Kojic, Erna
AU - Robbins, Gregory K.
AU - Lerner, Jonathan A.
AU - Herman, Debra S.
AU - Mimiaga, Matthew J.
AU - Mayer, Kenneth H.
N1 - Funding Information:
This study was funded by a National Institute of Mental Health grant R01MH084757 to SAS. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute of Mental Health or the National Institutes of Health. Some of the author time, and resources for statistical consultation, were also supported by grants National Institute of Allergy and Infectious Diseases (NIAID) 5P30AI060354 and P30AI042853 . We thank study interventionists, assessors, and research assistants working on daily study operations, quality assurance, recruitment, and other study coordination tasks; the Harvard Center for AIDS Research (CFAR) and Heather Ribaudo specifically for statistical consultation; the participants for their time and effort to complete the study assessments and procedures; and the Community Advisory Board at Fenway Health who gave input regarding the design and the recruitment of participants.
PY - 2016/11/1
Y1 - 2016/11/1
N2 - Background 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. Methods 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. Findings 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. Interpretation 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. Funding National Institute of Mental Health, National Institute of Allergy and Infectious Diseases.
AB - Background 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. Methods 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. Findings 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. Interpretation 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. Funding National Institute of Mental Health, National Institute of Allergy and Infectious Diseases.
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U2 - 10.1016/S2352-3018(16)30053-4
DO - 10.1016/S2352-3018(16)30053-4
M3 - Article
C2 - 27658881
AN - SCOPUS:84994726329
VL - 3
SP - e529-e538
JO - The Lancet HIV
JF - The Lancet HIV
SN - 2352-3018
IS - 11
ER -