Hepatitis C Clinical Trial
Official title:
Preventing Depression in MMT Patients on Interferon
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
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