Cognitive behavioural therapy for adherence and depression in patients with HIV: a three-arm randomised controlled trial

Steven Safren, C. Andres Bedoya, Conall O'Cleirigh, Katie B. Biello, Megan M. Pinkston, Michael D. Stein, Lara Traeger, Erna Kojic, Gregory K. Robbins, Jonathan A. Lerner, Debra S. Herman, Matthew J. Mimiaga, Kenneth H. Mayer

Research output: Contribution to journalArticle

29 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)e529-e538
JournalThe Lancet HIV
Volume3
Issue number11
DOIs
StatePublished - Nov 1 2016

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Cognitive Therapy
Randomized Controlled Trials
HIV
Depression
Counseling
Therapeutics
Acquired Immunodeficiency Syndrome
National Institute of Allergy and Infectious Diseases (U.S.)
National Institute of Mental Health (U.S.)
Community Health Centers
New England
Random Allocation
Psychotherapy
Antidepressive Agents
Cost-Benefit Analysis
Epidemiologic Studies
Software
Injections

ASJC Scopus subject areas

  • Epidemiology
  • Immunology
  • Infectious Diseases
  • Virology

Cite this

Safren, S., Bedoya, C. A., O'Cleirigh, C., Biello, K. B., Pinkston, M. M., Stein, M. D., ... Mayer, K. H. (2016). Cognitive behavioural therapy for adherence and depression in patients with HIV: a three-arm randomised controlled trial. The Lancet HIV, 3(11), e529-e538. https://doi.org/10.1016/S2352-3018(16)30053-4

Cognitive behavioural therapy for adherence and depression in patients with HIV : a three-arm randomised controlled trial. / Safren, Steven; Bedoya, C. Andres; O'Cleirigh, Conall; Biello, Katie B.; Pinkston, Megan M.; Stein, Michael D.; Traeger, Lara; Kojic, Erna; Robbins, Gregory K.; Lerner, Jonathan A.; Herman, Debra S.; Mimiaga, Matthew J.; Mayer, Kenneth H.

In: The Lancet HIV, Vol. 3, No. 11, 01.11.2016, p. e529-e538.

Research output: Contribution to journalArticle

Safren, S, Bedoya, CA, O'Cleirigh, C, Biello, KB, Pinkston, MM, Stein, MD, Traeger, L, Kojic, E, Robbins, GK, Lerner, JA, Herman, DS, Mimiaga, MJ & Mayer, KH 2016, 'Cognitive behavioural therapy for adherence and depression in patients with HIV: a three-arm randomised controlled trial', The Lancet HIV, vol. 3, no. 11, pp. e529-e538. https://doi.org/10.1016/S2352-3018(16)30053-4
Safren, Steven ; Bedoya, C. Andres ; O'Cleirigh, Conall ; Biello, Katie B. ; Pinkston, Megan M. ; Stein, Michael D. ; Traeger, Lara ; Kojic, Erna ; Robbins, Gregory K. ; Lerner, Jonathan A. ; Herman, Debra S. ; Mimiaga, Matthew J. ; Mayer, Kenneth H. / Cognitive behavioural therapy for adherence and depression in patients with HIV : a three-arm randomised controlled trial. In: The Lancet HIV. 2016 ; Vol. 3, No. 11. pp. e529-e538.
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AU - Safren, Steven

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.

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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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