Cognitive Behavioral Adherence Intervention for Depressed HIV Patients
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- RAND
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Microelectronic medication adherence
研究概览
简要总结
This study will compare the effectiveness of a cognitive behavioral intervention versus usual clinic care in helping HIV infected adults with depression to take their HIV medications on schedule.
详细描述
Antiretroviral therapy (ART) is a type of medication treatment for HIV that impairs the virus's ability to multiply. When used properly, it has been shown to be successful in reducing HIV-related deaths. A high adherence rate to ART is required to adequately suppress the virus, limit drug resistance, and reduce transmission. HIV infected people who are depressed often experience increased difficulty with adhering to their ART regimen. This study will compare the effectiveness of a cognitive behavioral intervention that targets both depression and adherence versus usual care practices which may or may not include mental health intervention with the goal of improving ART adherence among HIV infected adults with depression who are experiencing difficulty with adhering to their medication regimen.
This study will last 24 weeks. Participants will be randomly assigned to receive the cognitive behavioral intervention or usual care. Study visits for all participants will occur at baseline and Weeks 4, 8, 16, and 24. Those receiving the intervention will also have visits at Weeks 1 and 2. Participants receiving the intervention will attend five individual treatment sessions followed by one to three booster treatment sessions; these sessions will coincide with the study visits.
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •reports significant depressive symptoms as indicated by score of 10 or greater on PHQ-9
- •Currently taking ART for HIV infection
- •Less than 90% adherence rate to ART regimen
- •Capable of walking and in stable health
- •Speaks fluent English
排除标准
- •Depression therapy is needed immediately
- •Meets criteria for current drug dependency
- •Current diagnosis of psychotic disorder or bipolar depression
研究组 & 干预措施
1
Participants will receive usual clinical care, which may or may not include mental health treatment
2
Participants will receive cognitive behavioral intervention
干预措施: Cognitive behavioral therapy (CBT) (Behavioral)
结局指标
主要结局
Microelectronic medication adherence
时间窗: Measured at Weeks 16 and 24
次要结局
- Self-reported depression(Measured at Weeks 16 and 24)
