An interventional study of Group Training in Hepatitis C and Depression, sponsored by South Texas Veterans Health Care System. Status unknown at 1 site in United States. Open to participants aged 25 Years to 68 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2007-12-14.
Sponsored by South Texas Veterans Health Care System · Not applicable, Interventional, and Prevention
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.
2,321 studies on the registry are indexed under Hepatitis C; 102 are open to participants now.
This study's planned enrollment of 90 is above the median of 79 across 1,633 interventional studies indexed under Hepatitis C.
Browse Hepatitis C studies →South Texas Veterans Health Care System is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will be trained in techniques that are useful to cope with possible side effects of treatment, such as: keeping a journal (expressive writing), breathing exercises, cognitive behavioral therapy, mindfulness meditation, and exercise.
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
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
This study is status unknown, as verified in Dec 2007. You cannot join it, but the record below documents what was studied.
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South Texas Veterans Health Care System