Assessing the effect of Measurement-Based Care depression treatment on HIV medication adherence and health outcomes: Rationale and design of the SLAM DUNC Study
Department of Community and Family Medicine, Duke University, Durham, NC 27705, USA. Contemporary clinical trials
(Impact Factor: 1.94).
04/2012; 33(4):828-38. DOI: 10.1016/j.cct.2012.04.002
Depression affects 20-30% of people living with HIV/AIDS (PLWHA) in the U.S. and predicts greater sexual risk behaviors, lower antiretroviral (ARV) medication adherence, and worse clinical outcomes. Yet little experimental evidence addresses the critical clinical question of whether depression treatment improves ARV adherence and clinical outcomes in PLWHA with depression. The Strategies to Link Antidepressant and Antiretroviral Management at Duke, UAB, and UNC (SLAM DUNC) Study is a randomized clinical effectiveness trial funded by the National Institute for Mental Health. The objective of SLAM DUNC is to test whether a depression treatment program integrated into routine HIV clinical care affects ARV adherence. PLWHA with depression (n=390) are randomized to enhanced usual care or a depression treatment model called Measurement-Based Care (MBC). MBC deploys a clinically supervised Depression Care Manager (DCM) to provide evidence-based antidepressant treatment recommendations to a non-psychiatric prescribing provider, guided by systematic and ongoing measures of depressive symptoms and side effects. MBC has limited time requirements and the DCM role can be effectively filled by a range of personnel given appropriate training and supervision, enhancing replicability. In SLAM DUNC, MBC is integrated into HIV care to support HIV providers in antidepressant prescription and management. The primary endpoint is ARV adherence measured by unannounced telephone-based pill counts at 6 months with follow-up to 12 months and secondary endpoints including viral load, health care utilization, and depressive severity. Important outcomes of this study will be evidence of the effectiveness of MBC in treating depression in PLWHA and improving HIV-related outcomes.
Available from: Angela Bengtson
- "speaking, aged 18–65, screened positive for depression (score ≥10) on the Patient Health Questionnaire-9 (Spitzer, Kroenke, Williams, & the Patient Health Questionnaire Primary Care Study Group, 1999), and had a confirmed current major depressive disorder on the Mini International Neuropsychiatric Interview (Sheehan et al., 1998). Exclusion criteria included history of bipolar or psychotic disorder, failure of ≥2 adequate antidepressant trials, or psychiatric presentation requiring acute intervention (Pence et al., 2012). Participants were randomized to receive either enhanced usual care or a depression treatment model called Measurement-based Care (Adams et al., 2012). "
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ABSTRACT: Improving quality of life (QOL) for HIV-infected individuals is an important objective of HIV care, given the considerable physical and emotional burden associated with living with HIV. Although worse QOL has been associated with depression, no research has quantified the potential of improvement in depression to prospectively improve QOL among HIV-infected adults. We analyzed data from 115 HIV-infected adults with depression enrolled in a randomized controlled trial to evaluate the effectiveness of improved depression care on antiretroviral drug adherence. Improvement in depression, the exposure of interest, was defined as the relative change in depression at six months compared to baseline and categorized as full response (≥50% improvement), partial response (25-49% improvement), and no response (<25% improvement). Multivariable linear regression was used to investigate the relationship between improvement in depression and four continuous measures of QOL at six months: physical QOL, mental QOL, HIV symptoms, and fatigue intensity. In multivariable analyses, physical QOL was higher among partial responders (mean difference [MD] = 2.51, 95% CI: -1.51, 6.54) and full responders (MD = 3.68, 95% CI: -0.36, 7.72) compared to individuals who did not respond. Mental QOL was an average of 4.01 points higher (95% CI: -1.01, 9.03) among partial responders and 14.34 points higher (95% CI: 9.42, 19.25) among full responders. HIV symptoms were lower for partial responders (MD = -0.69; 95% CI: -1.69, 0.30) and full responders (MD = -1.51; 95% CI: -2.50, -0.53). Fatigue intensity was also lower for partial responders (MD = -0.94; 95% CI: -1.94, 0.07) and full responders (MD = -3.00; 95% CI: -3.98, -2.02). Among HIV-infected adults with depression, improving access to high-quality depression treatment may also improve important QOL outcomes.
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ABSTRACT: Depressed mood is highly prevalent among HIV-infected individuals. Some but not all studies have found group psychotherapy to be efficacious in this population. We performed a systematic review and meta-analysis of double-blinded, randomized controlled trials to examine efficacy of group psychotherapy treatment among HIV infected with depressive symptoms. We used PubMed, the Cochrane database, and a search of bibliographies to find controlled clinical trials with random assignment to group psychotherapy or control condition among HIV infected patients with depressive symptoms. The principal measure of effect size was the standard difference between means on validated depression inventories. We identified 8 studies that included 665 subjects: 5 used cognitive behavioral therapy (CBT), 2 used supportive therapy, and 1 used coping effectiveness training. Three of the 8 studies reported significant effects. The pooled effect size from the random effects model was 0.38 (95% confidence interval [CI]: 0.23-0.53) representing a moderate effect. Heterogeneity of effect was not found to be significant (p = 0.69; I(2) = 0%). Studies reporting use of group CBT had a pooled effect size from the random effects model of 0.37 (95% CI: 0.18-0.56) and was significant. Studies reporting the use of group supportive psychotherapy had a pooled effect size from the random effects model 0.58 (95% CI: -0.05-1.22) and was nonsignificant. The results of this study suggest that group psychotherapy is efficacious in reducing depressive symptoms among, HIV-infected individuals. Of note, women were nearly absent from all studies. Future studies should be directed at addressing this disparity.
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ABSTRACT: Depressed mood has been associated with HIV transmission risk behavior. To determine whether effective depression treatment could reduce the frequency of sexual risk behavior, we analyzed secondary outcome data from a 36-week, two-arm, parallel-design, randomized controlled trial, in which homeless and marginally housed, HIV-infected persons with comorbid depressive disorders were randomized to receive either: (a) directly observed treatment with the antidepressant medication fluoxetine, or (b) referral to a local public mental health clinic. Self-reported sexual risk outcomes, which were measured at 3, 6, and 9 months, included: total number of sexual partners, unprotected sexual intercourse, unprotected sexual intercourse with an HIV-uninfected partner or a partner of unknown serostatus, and transactional sex. Estimates from generalized estimating equations regression models did not suggest consistent reductions in sexual risk behaviors resulting from treatment. Mental health interventions may need to combine depression treatment with specific skills training in order to achieve durable impacts on HIV prevention outcomes.
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