reducing depressive symptoms during hcv therapy: a randomized study

Conditions: Hepatitis C; Depression

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).

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.

Eligibility criteria:
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.

Keywords: hepatitis c hcv depression interferons ribavirin