Reducing Depressive Symptoms During HCV Therapy: A Randomized Study

Study Overview
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Brief Summary
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The purpose of this study is to conduct a randomized controlled trial of an 8-visit non-pharmacologic group intervention in reducing the severity of depressive symptoms in veterans who receive IFN and ribavirin for the treatment of Hepatitis C. We hypothesize that over the first 6 months of treatment with IFN and ribavirin for the 45 patients who receive the 8-visit intervention early in the course of treatment in addition to usual care (experimental group) will have lower scores on the CES-D, a standard depression rating scale, than the 45 patients who receive only usual care (control group).

Detailed Description
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In this study, subjects will be randomly assigned (by chance, like the flipping of a coin) to one of two study groups. Half the subjects will be assigned to a training program, which will consist of 8 sessions over a period of 8 weeks in which they will be instructed in cognitive therapy ( a method of identifying and talk back to one's negative thoughts) and a variety of other stress-reducing techniques. The other half will be assigned to a control groups, which will no receive instruction in cognitive therapy or the other stress-reducing techniques. All subjects, both those in the training program and in the control group, will receive the usual care for hepatitis C that all patients in the Hepatology Clinic receive. All subjects will also be asked to participate in 6 testing visits over the course of the study. The first testing visit will last about 3 hours, which the others will last between 1 1/2 and 2 hours. Subjects will alo be interviewed by telephone about their personal and family medical and psychiatric history. This will take about an hour.

Official Title
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Reducing Depressive Symptoms During HCV Therapy: A Randomized Study

Conditions
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Hepatitis C, Depression

Intervention / Treatment
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* Behavioral: Group Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eligibility and interest in treatment for chronic HCV (Hepatitis C). Absence of co-infection of HIV or Hepatitis B. Age 25-68 years old. No treatment with IFN (interferon-alpha) in the past 6 months. Residence within a 3-hour drive of the clinic. Exclusion Criteria: Patients must be willing to undergo treatment with PEG-interferon and ribavirin. They must be aware of the side effects of treatment and be motivated to self-administer the medications and come to regularly scheduled appointments. Patients with diabetes mellitus must have good glycemic control. Their Hgb A1 c must be <8.0%. Patients must not have an active malignancy. If patients have a history of severe psychiatric illness or are found to have one by screening with the CES-D, a psychiatrist must approve treatment. If the psychiatric problem is minor, it can be managed by the primary care physician or hepatitis C provider. Autoimmune disease, such as autoimmune hepatitis, systemic lupus erythematosis, or sarcoidosis, is a contraindication to treatment. Active alcohol or intravenous drug use is a contraindication to treatment. Patients with a seizure disorder muct be seizure-free for 6 months prior to treatment. Patients with a known history of coronary heart disease are excluded. Patients with complications of cirrhosis may not be treatment candidates. Those who have a platelet count of <50,000, large esophageal varices (grade 3-4), uncontrolled ascites, or uncontrolled encephalopathy are excluded. Patients with severe mental retardation or dementia are excluded because of difficulty in self-administration of medication and in tolerating the side effects. The patient and partner much agree to observe strict contraception to avoid pregnancy, since the medication is fetotoxic up to 6 months after treatment completion.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 68 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Group Training|Participants will be trained in techniques that are useful to cope with possible side effects of treatment, such as: keeping a journal (expressive writing), breathing exercises, cognitive behavioral therapy, mindfulness meditation, and exercise.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients in the experimental group will have less of an increase in their HAM-D score over the first 6 months of treatment; score on a depression rating scale at study visits 1-5. |  | Two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients in the experimental group will have less of an increase in their PHQ-9 score over the first 6 months of treatment; score on a rating scale at study visits 1-5. |  | Two years | 
| Patients in the experimental group will have less of an increase in their BDI score over the first 6 months of treatment; score on a rating scale at study visits 1-5. |  | Two years | 
| Fewer patients in the experimental group will have developed a major depressive episode over the first 6 months of treatment; score on MDD module (MINI)at study visits 1-5. |  | Two years | 
| Patients in the experimental group will have less of a decline in their self-rated general health (item #1 of the SF-36) over the first 6 months of treatment. |  | Two years | 
| Patients in the experimental group will have less of an increase in self-rated irritability (item #6 of the BSI ) over the first 6 months of treatment. |  | Two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HCV, Hepatitis C, Depression, Interferons, Ribavirin