Preventing Depression in Methadone Maintenance Patients Receiving Hepatitis C Treatment - 1

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Preventing Depression in MMT Patients on Interferon

Conditions
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Depressive Disorder, Major, Hepatitis C

Intervention / Treatment
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* Behavioral: Cognitive behavioral treatment for depression


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Currently undergoing HCV treatment at RIH Enrolled in MMT for at least 6 months Exclusion Criteria: Current major depressive episode Current suicidality Currently taking antidepressant medication Received HCV treatment in past

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Depression prevention<br>Cognitive behavioral treatment for depression. | Behavioral: Cognitive behavioral treatment for depression<br>* Cognitive behavioral intervention to prevent depressive symptoms during treatment for hepatitis C<br>|
| No Intervention: Control<br>Treatment as usual. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| depression-related antiviral treatment failure |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis C, Depressive Symptoms