This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Chronic hepatitis C (HCV) affects millions of individuals in the U.S. and is especially prevalent among veterans. Because of this high prevalence, as well as the many adverse effects of HCV on health and the fact that it is potentially curable, the Veterans Health Administration has made treatment of this disease one of its top priorities. The major impediment to optimal HCV treatment is that the most effective therapy - a combination of subcutaneous pegylated interferon-alpha (IFN) and oral ribavarin - has a number of serious side effects, many of which are neuropsychiatric in nature. In this pilot project, we propose to develop a non-pharmacologic intervention to minimize the most serious of these, which is depression. We also propose to use the excellent opportunity provided by this trial to expand our knowledge about IFN-induced depression and another serious side effect of IFN treatment - cognitive impairment. We plan to study a total of 90 patients in this multi-disciplinary, clinic-based study. OBJECTIVE: The objective of this study is to evaluate the efficacy 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 HCV. We hypothesize that over the first six months of treatment with IFN and ribavirin, the 45 patients who receive the 8-visit intervention early in the course of treatment in addition to usual care (the experimental group) will have lower scores on the CES-D, a standard depression rating scale, than the 45 patients who receive only usual care (the control group). In the longer term, we plan to use the data from this pilot study to submit a Clinical Science Merit Review to conduct a larger, collaborative trial of our intervention in patients with HCV. If that study demonstrates the efficacy of such an approach, it could be a significant advance in the treatment of HCV.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR001346-25
Application #
7378212
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2006-04-01
Project End
2007-03-31
Budget Start
2006-04-01
Budget End
2007-03-31
Support Year
25
Fiscal Year
2006
Total Cost
$82,954
Indirect Cost
Name
University of Texas Health Science Center San Antonio
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
800772162
City
San Antonio
State
TX
Country
United States
Zip Code
78229
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