Reducing Depressive Symptoms During HCV Therapy: A Randomized Study
Recruitment status was Active, not recruiting
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Purpose
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).
| Condition | Intervention |
|---|---|
|
Hepatitis C Depression |
Behavioral: Group Training |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Reducing Depressive Symptoms During HCV Therapy: A Randomized Study |
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 90 |
| Study Start Date: | July 2004 |
| Estimated Study Completion Date: | December 2007 |
-
Behavioral: Group Training
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| Ages Eligible for Study: | 25 Years to 68 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations| United States, Texas | |
| South Texas Veterans Healthcare System, Audie Murphy Division | |
| San Antonio, Texas, United States, 78229 | |
| Principal Investigator: | Stephen L. Stern, M.D. | South Texas Veterans Hospital, Audie Murphy Division & the University of Texas Health Science Center at San Antonio |
More Information
Publications:
| Responsible Party: | Dr, Stephen L. Stern, Audie L. Murphy VA Hospital |
| ClinicalTrials.gov Identifier: | NCT00495768 History of Changes |
| Other Study ID Numbers: | 034-0013-391 |
| Study First Received: | July 2, 2007 |
| Last Updated: | December 13, 2007 |
| Health Authority: | United States: Federal Government |
Keywords provided by South Texas Veterans Health Care System:
|
Hepatitis C HCV Depression Interferons Ribavirin |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Hepatitis Hepatitis A Hepatitis C Behavioral Symptoms Mood Disorders Mental Disorders |
Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections |
ClinicalTrials.gov processed this record on May 19, 2013