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Sponsored by: |
South Texas Veterans Health Care System |
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Information provided by: | South Texas Veterans Health Care System |
ClinicalTrials.gov Identifier: | NCT00495768 |
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 |
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Hepatitis C Depression |
Behavioral: Group Training |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Reducing Depressive Symptoms During HCV Therapy: A Randomized Study |
Estimated Enrollment: | 90 |
Study Start Date: | July 2004 |
Estimated Study Completion Date: | December 2007 |
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.
Ages Eligible for Study: | 25 Years to 68 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
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 |
Responsible Party: | Audie L. Murphy VA Hospital ( Dr, Stephen L. Stern ) |
Study ID Numbers: | 034-0013-391 |
Study First Received: | July 2, 2007 |
Last Updated: | December 13, 2007 |
ClinicalTrials.gov Identifier: | NCT00495768 |
Health Authority: | United States: Federal Government |
Hepatitis C HCV Depression Interferons Ribavirin |
Liver Diseases Depression Ribavirin Interferons Hepatitis, Viral, Human Depressive Disorder Behavioral Symptoms |
Hepatitis Virus Diseases Digestive System Diseases Mental Disorders Mood Disorders Hepatitis C |
RNA Virus Infections Flaviviridae Infections |