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

Abstract

Summary Background Depression, highly prevalent in HIV, is consistently associated with worse ART adherence. Integrating CBT for depression with adherence counseling using the “Life-Steps” approach (CBT-AD) has an emerging evidence base. The aim of the current study was to test the efficacy of CBT-AD. Methods We conducted a three-arm RCT (N=240 HIV-positive adults with depression), comparing CBT-AD to Life-Steps integrated with information and supportive psychotherapy (ISP-AD) (both 12 sessions), and to ETAU (1 session Life-Steps). Participants were recruited from three sites in New England area, two being hospital settings, and one being a community health center. Randomization was done via a 2:2:1 ratio, using random allocation software by the data manager, in pairs, stratified by three variables: site, whether or not the participant was prescribed antidepressant medications, and history of injection drug use. The primary outcome was adherence assessed via electronic pill caps (MEMs) with correction for “pocketed” doses. Secondary outcomes included depression, plasma HIV RNA and CD4. Follow-ups occurred at 4, 8 and 12 months. We used intent-to treat analyses with ANCOVA for independent-assessor pre-post assessments of depression and mixed effects modeling for longitudinal assessments. Clinical Trial Registration: NCT00951028, https://clinicaltrials.gov/ct2/show/NCT00951028), closed to new participants. Findings The period of recruitment was February 26, 2009 to June 21, 2012, with the 12-month follow-up period extending until April 29, 2013. There were no study-related adverse events. CBT-AD (n=94 randomized, 83 retained) had greater improvements in adherence (Est.=1·00, CI=0·34, 1·66, p=0·003) and depression (CES-D Est.=−0·41, CI=−0·66, −0·16, p=0·001; MADRS Est.=−4·69, CI=−8·09, −1·28, p=0·007; CGI Est.=−0·66, CI=−1·11,-0·21, p=0·005) than ETAU (49 randomized, 46 retained) at post-treatment (4-month). Over follow-ups, CBT-AD (84 retained) maintained higher adherence (Est.=8·93, CI=1·90, 15·97, p=0·013) and lower depression on the CES-D (Est=−3·56, CI=−6·08, −1·05, p=·005) and CGI (Est.=−0·39, CI=−0·77, −0·18, p=·04) than ETAU (86 retained); however, not for the MADRS. There were no significant differences between CBT-AD and ISP-AD (97 randomized, 87 retained) for the post-treatment or follow-up (86 retained) analyses. There were no intervention effects on HIV RNA or CD4, though a higher percentage (91·4%) than expected was virally suppressed at baseline. Interpretation Integrating evidenced-based treatment for depression with evidenced-based adherence counseling is helpful for individuals living with HIV/AIDS and depression. Future efforts should examine how to best disseminate of effective psychosocial depression treatments such as CBT-AD to individuals living with HIV/AIDS, as well as examine the cost-effectiveness of such approaches. Funding National Institute of Mental Health (R01MH084757) and some author time from NIAID 5P30AI060354, and P30AI042853.

The Relationship Between Automatic Thoughts and Depression in a Cognitive-Behavioral Treatment for People Living with HIV/AIDS: Exploring Temporality and Causality

“…The parent study was a 12-month, 3-arm randomized controlled efficacy trial (Safren et al 2016). The arms were 1) CBT-AD, 2) ISP-AD and 3) ETAU, as described below.…”

“…The parent study focused on CBT-AD versus ETAU and ISP-AD for depression and medication adherence in people living with HIV/AIDS (Safren et al, 2016). The parent study found that patients who were assigned to CBT-AD had greater improvements in adherence than did patients who had ETAU after treatment.…”

“…One evidenced-based approach, cognitive-behavioral therapy for adherence and depression (CBT-AD), has a growing evidence base in individuals with chronic illness, such as in PLWHA (Brown et al 2016; Safren et al 2009, 2012, 2016; Simoni et al 2013) and diabetes (Safren et al 2014), despite its challenges in application (Simoni et al 2011). CBT-AD contains interventions that specifically address medication adherence and, for depression, modules for behavioral activation, cognitive restructuring with a particular focus on negative automatic thoughts (ATs), problem-solving, and relaxation training.…”

Comparison of levels of anxiety and depression between women and men living with HIV of a Mexico City clinic

“…Anxiety and especially depression have consistently been associated with poor antiretroviral treatment (ART) adherence (Safren et al, 2016;Smith Fawzi et al, 2016;Tao et al, 2016;Tatum & Houston, 2016), and are linked to poor virological control and lower CD4 T cell counts (Amanor-Boadu et al, 2016;Herkenham & Kigar, 2016).…”

Smoking Predicts Food Insecurity Severity among Persons Living with HIV

“…Clinical research has documented the efficacy of cognitive-behavioral interventions targeting depression and substance use to optimize HIV/AIDS prevention [40,41]. However, the efficacy of smoking cessation interventions for PLHIV have been modest at best [42,43], and many have not been tailored to address the unique barriers to smoking cessation.…”