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临床试验/NCT00509340
NCT00509340终止1 期

Cognitive Behavioral Adherence Intervention for Depressed HIV Patients

RAND1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2007年6月1日最近更新:
适应症
干预措施

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

No Intervention

Participants will receive usual clinical care, which may or may not include mental health treatment

2

Experimental

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)

研究者

发起方
RAND
申办方类型
Other
责任方
Principal Investigator
主要研究者

Glenn Wagner

Senior Behavioral Scientist

RAND

研究点 (1)

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