CBT for Depression & Adherence in HIV Methadone Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 2
- 主要终点
- Percent Medication Adherence at 3-month Follow-up Assessment
研究概览
简要总结
Patients with HIV, depression, and opioid-dependence are at high risk for poor health outcomes. This is a two-arm randomized controlled trial of cognitive-behavioral therapy for depression and HIV medication adherence in patients with opioid dependence who are receiving methadone maintenance treatment. The project is based on our pilot work with close attention to NIDA guidelines for a staged approach to treatment development and testing (Rounsaville et al., 2001).
Depression is highly comorbid with both HIV infection and with opioid dependence. Depression and substance abuse are both associated with poor adherence to antiretroviral medications. Patients with HIV, depression, and opioid dependence are at high risk for poor health outcomes. Cognitive-behavioral therapy is the most widely studied and efficacious psychosocial intervention for depression; and research by the PI and others has shown that cognitive-behavioral interventions have been successful in promoting adherence to HIV medications.
详细描述
Symptoms of depression (i.e. low motivation, poor concentration, loss of interest, sad mood, suicidal ideation) that occur in the context of substance abuse or dependence can interfere with self-care behaviors necessary for maintaining HIV care, as well as interfere with potential benefit from an intervention that focuses on adherence alone. We hypothesize that teaching skills to cope with depression will improve the outcome from an adherence intervention to promote healthier living with HIV, in HIV+ opioid dependent individuals in methadone maintenance treatment.
Overview of Research Plan. Patients who are HIV positive and who are receiving methadone maintenance for opioid dependence will be randomized to treatment with either: (1) CBT, a combination of CBT for depression and HIV medication adherence, including a single session intervention for HIV medication adherence (Life-Steps, Safren et al., 2001) in conjunction with physician feedback regarding baseline study assessments or (2) the single session intervention for HIV medication adherence (Life-Steps, Safren et al., 2001) in conjunction with physician feedback regarding baseline study assessments. Participants will be followed for one-year post-randomization.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV seropositive
- •Currently enrolled in methadone maintenance treatment for at least one month
- •Current major or subsyndromal depression (subsyndromal depression is defined by major depression that does not meet full diagnostic criteria but with a clinical global impression of severity (CGI-S) of 2 (mildly ill))
- •Is prescribed antiretroviral therapy for HIV and therefore under the care of a primary care provider.
- •Between the ages of 18 and 65.
排除标准
- •Active untreated, unstable, major mental illness (i.e., untreated psychosis or mania), or other Axis I psychiatric disorders (other than depression) that would interfere with the ability to participate (i.e. CGI-S >6)
- •Unable or unwilling to provide informed consent.
- •Currently in cognitive behavioral therapy for depression.
研究组 & 干预措施
CBT-AD
Cognitive behavioral therapy for adherence and depression
干预措施: CBT-AD (Behavioral)
ETAU
Enhanced treatment as usual
干预措施: ETAU (Behavioral)
结局指标
主要结局
Percent Medication Adherence at 3-month Follow-up Assessment
时间窗: 3-month assessment
Post-treatment assessment in adherence to HIV medication. Doses taken were assessed by downloading information from the electronic pill cap and corroborated by participant self-report. Adherence was calculated as the number of doses taken over the time period divided by the number of doses prescribed.
Percent Medication Adherence at 12-month Follow-up Assessment
时间窗: 12-month follow-up assessment
Follow-up assessment in adherence to HIV medication. Doses taken were assessed by downloading information from the electronic pill cap and corroborated by participant self-report. Adherence was calculated as the number of doses taken over the time period divided by the number of doses prescribed.
次要结局
- Clinician-assessed Depression Rating at 3 Month Follow-up Assessment(3 month follow-up)
- Clinician-assessed Depression at 12-month Follow-up Assessment(12-month follow-up assessment)
- HIV Viral Load at 12-month Follow-up Assessment(12-month follow-up assessment)
- HIV Viral Load at 3-month Follow-up Assessment(3-month assessment)
- CD4+ Lymphocyte Count at 12-month Follow-up Assessment.(12-month follow-up assessment)
- CD4+ Lymphocyte Count at 3-month Follow-up Assessment.(3-month assessment)
研究者
Steven A. Safren
Director, Behavioral Medicine
Massachusetts General Hospital