Health Behavior Feedback Study for Veterans With Hepatitis C - Full Text View

Sponsors and Collaborators:	University of Washington Alcoholic Beverage Medical Research Foundation
Information provided by:	University of Washington
ClinicalTrials.gov Identifier:	NCT00229580

Purpose

The purpose of this study was to explore whether a brief (3 session) intervention would impact health behavior of veterans with hepatitis C. The main focus of the intervention was on reduction of heavy drinking with patients who have liver disease. Other study goals were to increase the likelihood that patients would seek out substance use treatment and/or hepatitis C health care services. The study also tested the use of a liver function test called CDT/GGT in detecting heavy drinking. The main hypothesis was that a 3 session intervention with personalized feedback about health behavior would result in a reduction in alcohol use and increased use of substance use treatment and hepatology health care.

Condition	Intervention	Phase
Alcoholism Alcohol Abuse Hepatitis C Liver Disease	Behavioral: 3 session brief intervention with health behavior feedback Other: treatment as usual	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Health Behavior Feedback Study for Veterans With Hepatitis C

Resource links provided by NLM:

MedlinePlus related topics: Alcoholism Healthy Living Hepatitis Hepatitis C Liver Diseases

U.S. FDA Resources

Further study details as provided by University of Washington:

Primary Outcome Measures:

Reduction in alcohol consumption [ Time Frame: at 6 and 12-week follow-up. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Engagement in substance use treatment and hepatitis C specialty care. Detection of elevated CDT in blood serum compared with self-reported heavy drinking. [ Time Frame: 12 weeks post-study ] [ Designated as safety issue: No ]

Enrollment:	12
Study Start Date:	December 2003
Study Completion Date:	January 2006

Arms	Assigned Interventions
1: Experimental Motivational feedback	Behavioral: 3 session brief intervention with health behavior feedback
2: Active Comparator treatment as usual	Other: treatment as usual

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Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Positive serology for current infection by hepatitis C viremia by PCR confirmation test;
Current alcohol use (past 30 days) as indicated by self-report (using AUDIT- C questions);
Meets hazardous alcohol use criteria as measured by the Alcohol Use Disorders Identification Test.

Criteria per (National Institute on Alcohol Abuse and Alcoholism, 1995):
1. for women, 7 or more drinks per week or 4 or more drinks per occasion;
2. for men, 14 or more drinks per week or 5 or more drinks per occasion;
Not currently engaged (past 30 days) in VA specialty substance use disorder treatment or mutual help groups like AA/NA.

Exclusion Criteria:

Abstinent from alcohol use in last 30 days as indicated by self-report or less than hazardous use according to criteria listed above by the AUDIT.
Patient is already engaged (past 30 days) in specialty substance use disorder treatment or attends self-help groups.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00229580

Locations

United States, Washington
VA Puget Sound Health Care System
Seattle, Washington, United States, 98108

Sponsors and Collaborators

University of Washington

Alcoholic Beverage Medical Research Foundation

Investigators

Principal Investigator:

Tania M Davis Correale, PhD

Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine

More Information

No publications provided

Responsible Party:	VA PSHCS/UWashington ( Tania Correale, Ph.D. )
Study ID Numbers:	03-8752-V 03
Study First Received:	September 27, 2005
Last Updated:	November 28, 2007
ClinicalTrials.gov Identifier:	NCT00229580 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Washington:

Brief Intervention
Motivational Interviewing
Health Psychology

Alcohol
Hepatitis C
Patient Education

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
Mental Disorders
Alcoholism

Substance-Related Disorders
Hepatitis, Viral, Human
Disorders of Environmental Origin
Alcohol-Related Disorders
Hepatitis C
Ethanol

Additional relevant MeSH terms:

Liver Diseases
RNA Virus Infections
Flaviviridae Infections
Disorders of Environmental Origin
Hepatitis, Viral, Human
Hepatitis
Virus Diseases

Digestive System Diseases
Mental Disorders
Alcoholism
Substance-Related Disorders
Alcohol-Related Disorders
Hepatitis C

ClinicalTrials.gov processed this record on September 03, 2009