Overview

This trial is active, not recruiting.

Conditions hepatitis c, depression
Treatment group training
Sponsor South Texas Veterans Health Care System
Start date July 2004
End date December 2007
Trial size 90 participants
Trial identifier NCT00495768, 034-0013-391

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention

Primary Outcomes

Measure
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.
time frame: Two years

Secondary Outcomes

Measure
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.
time frame: 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.
time frame: 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.
time frame: 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.
time frame: 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.
time frame: Two years

Eligibility Criteria

Male or female participants from 25 years up to 68 years old.

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.

Additional Information

Official title Reducing Depressive Symptoms During HCV Therapy: A Randomized Study
Principal investigator Stephen L. Stern, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2007.
Information provided to ClinicalTrials.gov by South Texas Veterans Health Care System.