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Health Behavior Feedback Study for Veterans With Hepatitis C

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00229580
Recruitment Status : Completed
First Posted : September 29, 2005
Last Update Posted : November 30, 2007
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Alcoholism Alcohol Abuse Hepatitis C Liver Disease Behavioral: 3 session brief intervention with health behavior feedback Other: treatment as usual Phase 1

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Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Health Behavior Feedback Study for Veterans With Hepatitis C
Study Start Date : December 2003
Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Motivational feedback
Behavioral: 3 session brief intervention with health behavior feedback
Active Comparator: 2
treatment as usual
Other: treatment as usual

Outcome Measures

Primary Outcome Measures :
  1. Reduction in alcohol consumption [ Time Frame: at 6 and 12-week follow-up. ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Positive serology for current infection by hepatitis C viremia by PCR confirmation test;
  2. Current alcohol use (past 30 days) as indicated by self-report (using AUDIT- C questions);
  3. 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;
  4. Not currently engaged (past 30 days) in VA specialty substance use disorder treatment or mutual help groups like AA/NA.

Exclusion Criteria:

  1. 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.
  2. Patient is already engaged (past 30 days) in specialty substance use disorder treatment or attends self-help groups.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00229580

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
Principal Investigator: Tania M Davis Correale, PhD Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine
More Information

Responsible Party: Tania Correale, Ph.D., VA PSHCS/UWashington
ClinicalTrials.gov Identifier: NCT00229580     History of Changes
Other Study ID Numbers: 03-8752-V 03
First Posted: September 29, 2005    Key Record Dates
Last Update Posted: November 30, 2007
Last Verified: November 2007

Keywords provided by University of Washington:
Brief Intervention
Motivational Interviewing
Health Psychology
Hepatitis C
Patient Education

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders