Ignite Creation Date:
2024-05-05 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00495768
Status:
UNKNOWN
Last Update Posted:
2007-12-14
First Post:
2007-07-02
Brief Title:
Reducing Depressive Symptoms During HCV Therapy A Randomized Study
Sponsor:
South Texas Veterans Health Care System
Organization:
South Texas Veterans Health Care System
Study Overview
Official Title:
Reducing Depressive Symptoms During HCV Therapy A Randomized Study
Status:
UNKNOWN
Status Verified Date:
2007-12
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 ones 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 12 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None