Efficacy of CBT for Adherence and Depression in HIV Care Settings
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 8
- 主要终点
- changes in HIV medication adherence, as measured by electronic medication event monitoring system (MEMS) pill-cap scores
研究概览
简要总结
This study will test a therapy for both helping people adhere to their HIV medication regimens and treating them for depression.
详细描述
People infected with HIV are more likely to suffer from depression than those not infected, with studies finding anywhere from 20% to 50% of HIV-infected individuals having significant depressive symptoms. Depression, in addition to causing persistent sadness and inability to feel pleasure, is related to a lack of HIV treatment adherence. Treatment adherence (making sure to take every pill as prescribed by doctors) is critically important to successful treatment of HIV, because missing even a few doses gives the HIV virus an opportunity to develop immunity to the medication. Poor adherence is related to worse medical outcomes, but even a small, 10% improvement rate in adherence may improve these outcomes. This study will test the efficacy of cognitive behavioral therapy (CBT) that addresses both depression and treatment adherence for HIV-infected people.
Participation in this study will last 1 year, including follow-up visits. All participants will complete an initial one-visit intervention addressing treatment adherence. Then after 2 weeks, participants will be randomly assigned to one of three conditions: CBT for HIV medication adherence and depression (CBT-AD), information and supportive psychotherapy for HIV medication adherence and depression (ISP-AD), or enhanced treatment as usual (ETAU). Participants receiving CBT-AD and ISP-AD will complete 12 therapy sessions over 4 months and will be asked to report any changes to their psychological or HIV treatments. CBT-AD will involve learning to identify and change problematic patterns of thought and behavior, while ISP-AD will involve education and supportive psychotherapy. Participants receiving ETAU will receive only the initial session on HIV medication adherence and will be asked about their psychological and HIV treatment every other week for 4 months.
Major study assessments will take place at baseline and after 4, 8, and 12 months. Assessments will include completing diagnostic interviews and questionnaires, measuring medication adherence through an electronic pill cap, and determining CD4 cell count and viral load (indicators of HIV treatment effectiveness).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-infected
- •Current diagnosis of depression or prescribed an antidepressant medication with at least some residual symptoms (e.g., clinical global impressions [CGI] scale score of 2 or greater)
- •Prescribed a stable regimen of highly active antiretroviral therapy (HAART) for HIV for at least 2 months
排除标准
- •Active, untreated, and unstable major mental illness (i.e., untreated psychosis or mania) that would interfere with cognitive behavioral therapy (CBT) treatment for depression
- •Diagnosis with any primary psychotic disorder, even if treated
- •Treatment with CBT within the past year
结局指标
主要结局
changes in HIV medication adherence, as measured by electronic medication event monitoring system (MEMS) pill-cap scores
时间窗: Measured at each visit - baseline, interim visits, and after 4, 8, and 12 months
HIV medication adherence is assessed more frequently during the acute study period (baseline to post-treatment), and then at the follow up major visits.
次要结局
- changes in Severity of depression, as assessed on the Montgomery-Asberg Depression Rating Scale (MADRS) by a blinded independent assessor(Measured at baseline and after 4, 8, and 12 months)
- changes in depression, as measured by the blinded assessor CGI rating(Measured at baseline and after 4, 8, and 12 months)
- changes in RNA viral load(Measured at baseline and after 4, 8, and 12 months)
- changes in CD4 cell count(Measured at baseline and after 4, 8, and 12 months)
- changes in self-reported depression (CESD)(Measured at each visit)
研究者
Steven A. Safren
Director, Behavioral Medicine
Massachusetts General Hospital