Reducing Depressive Symptoms During HCV Therapy: A Randomized Study

Depression Clinical Trial

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

Status Active, not recruiting

Clinical Trial Summary

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).

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Depression
• Hepatitis C

• NCT number: NCT00495768
• Study type: Interventional
• Source: South Texas Veterans Health Care System
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 2004
• Completion date: December 2007