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临床试验/NCT00218556
NCT00218556已完成不适用

Preventing Depression in MMT Patients on Interferon

National Institute on Drug Abuse (NIDA)2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2004年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
2
主要终点
depression-related antiviral treatment failure

研究概览

简要总结

The purpose of this study is develop and test a cognitive-behavioral intervention to prevent depression in methadone maintenance patients receiving medical treatment for hepatitis C.

详细描述

The purpose of this study is to develop a CBT-D intervention tailored to meet the needs of MMT patients undergoing antiviral treatment for hepatitis C. In the first phase of this project (Year 1), we will develop and pilot the intervention with 20 patients. In the second phase of the project (Years 2 and 3), we will conduct a preliminary, randomized trial with 60 MMT patients to examine the efficacy of the CBT-D intervention relative to standard care condition (SC).

We expect that, relative to the SC condition, participants randomized to the CBT-D condition will have decreased likelihood of depression-related antiviral treatment failure, will report lower levels of depressive symptoms, will complete more IFN injections, will have lower HCV RNA levels, and will have fewer illicit drug use days. If the efficacy of this intervention can be established in this trial and in subsequent clinical trials, MMT patients who elect to undergo antiviral therapy will have a valuable adjunct or alternative to the use of antidepressants to prevent depression. If found to be efficacious, this intervention will maximize the receipt of IFN treatment by MMT patients, thereby aiding in the prevention of liver failure, hepatocellular carcinoma, and liver-related death among those with HCV.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
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

入选标准

  • Currently undergoing HCV treatment at RIH
  • Enrolled in MMT for at least 6 months

排除标准

  • Current major depressive episode
  • Current suicidality
  • Currently taking antidepressant medication
  • Received HCV treatment in past

结局指标

主要结局

depression-related antiviral treatment failure

时间窗: 6 months

次要结局

未报告次要终点

研究者

申办方类型
Nih
责任方
Principal Investigator
主要研究者

Associate Professor (Research)

Rhode Island Hospital

研究点 (2)

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