- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00229580
Health Behavior Feedback Study for Veterans With Hepatitis C
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES: To establish the feasibility of a brief intervention for hepatitis C+ (HCV) patients who drink alcohol. The primary aim was reduction in alcohol use, which is known to be hazardous for patients with chronic HCV infection. Secondary aims were: 1) to increase patient engagement in substance use disorder (SUD) treatment, 2) to explore patient engagement in HCV specialty care, treatment acceptability, and impact on other health-related behaviors, and 3) to examine pre-post intervention differences in relation to report of alcohol use and to explore whether the CDT/GGT merits tracking to detect heavy drinking in this population, given hepatic pathology.
DESIGN: Randomized controlled trial with six-week and 12-week post-baseline assessment follow-up. The control group was offered the brief intervention at completion of the 12-week post-baseline follow-up.
PARTICIPANTS: We had anticipated recruiting 60 veterans who were HCV+, referred for HCV specialty care (education or treatment evaluation), and who met criteria for hazardous alcohol use. Due to problems with recruitment, only 12 veterans participated in the study (see below).
RECRUITMENT: We started regular study recruitment September 27, 2004 but study recruitment was much slower than anticipated. Despite multiple modifications to change our recruitment eligibility criteria, we enrolled only twelve subjects (N=12). Due to this ongoing recruitment problem, we decided to end study enrollment on 9/30/05 with follow-up completion in December 2005. Despite an extension of the Alcoholic Beverage Medical Research Foundation grant, there was no progress in identifying an alternative recruitment or developing an appropriate follow-up study.
MEASURES: Baseline assessment included demographic information, the Alcohol Use Disorders Identification Test (AUDIT), Form - 90 (recent alcohol and drug use), a DSM-IV SUD criteria checklist, a Health Behavior Questionnaire, and the K-10 (brief measure of psychological distress). For brief intervention feedback, the Short Inventory of Problems (negative consequences of alcohol use), the SOCRATES (stage of readiness to change), blood draw for liver function tests, and two brief measures of neuropsychological functioning were administered. VA treatment utilization data (SUD and specialty HCV treatment attendance) was obtained. Follow-up sessions also included measures of treatment acceptability and concept retention.
INTERVENTION: Participants in the brief intervention condition received personalized feedback and encouragement to explore ambivalence about change and treatment in three sessions. Feedback and interventions were tailored to individuals' health-related behavior with emphasis on alcohol use.
COMPLETION DATA: Ten participants were randomized to receive the feedback session and two were randomized to receive the treatment as usual or control group. Of the twelve participants enrolled, eight individuals (7 randomized, 1 control) completed all study sessions, one completed 2 of the 3 required sessions (1 control), and three who received the intervention completed only the initial baseline session.
DEMOGRAPHICS: We had eleven men and one female enroll in the study. The mean age of our participants was 55 years old. Five subjects identified themselves as African American or Black while seven identified themselves as Caucasian or White. Half (N=6) of the group were divorced and 42% (N=5) of the group were unemployed at the time they enrolled in the study. Over half (58%) of the subjects had completed some college in their lifetime.
SUD INFORMATION AND FEEDBACK: All subjects receiving the feedback sessions received a Personal Feedback Report at their first intervention session. This report incorporated data from the SOCRATES, SUD criteria checklist, Form 90 - revised, the SIP, and the Health Behavior Questionnaire which was collected at an earlier baseline session. For those receiving the feedback sessions (N=10), all had a primary diagnosis of alcohol dependence, while eight also endorsed use of additional substances (cocaine, opiates, cannabis and/or amphetamines).
Compared to individuals of the same gender in the population, the mean percentile rank of drinking norms was 97.5 (sd = 3.26). Based on data from the Form- 90 regarding typical weekly drinking patterns and levels of intoxication, the subjects in the feedback session had a reported mean Blood Alcohol Concentration (BAC) level of .13 (sd =.13) in a typical week, with a mean typical heavy day of drinking reaching a BAC of .23 (sd = .30). Subjects received feedback on the common effects of different levels of intoxication and how their self-reported drinking compared.
Besides receiving feedback on their drinking and the associated negative consequences, subjects also received feedback on their reported drug use. Cocaine and cannabis were the most frequently used drugs within the 30 days prior to the baseline, with subjects reporting mean use of 3.4 (sd = 6.7, sd =6.3, respectively) days out of 30. Subjects also received feedback on their smoking habits. Of the ten non-randomized subjects nine reported some tobacco use at baseline and no one reported decreased or discontinued use of tobacco after receiving the intervention.
TREATMENT ACCEPTABILITY: After the follow-up appointments we asked subjects (N=7) to rate their acceptance of the study intervention sessions on 14 different items ranging from their feelings of the discussions sessions to ratings on the therapist they met with throughout the study. Items were scored on a scale of 1-7. At the final follow-up 71% (N=5) reported the sessions as being valuable and easy to complete. Ninety percent (N=6) of the subjects who completed follow-up also reported the therapist as being helpful and caring towards them in the sessions.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98108
- VA Puget Sound Health Care System
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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):
- for women, 7 or more drinks per week or 4 or more drinks per occasion;
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 1
Motivational feedback
|
|
ACTIVE_COMPARATOR: 2
treatment as usual
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reduction in alcohol consumption
Time Frame: at 6 and 12-week follow-up.
|
at 6 and 12-week follow-up.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
12 weeks post-study
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Tania M Davis Correale, PhD, Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine
Study record dates
Study Major Dates
Study Start
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Digestive System Diseases
- Alcohol-Related Disorders
- Substance-Related Disorders
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Liver Diseases
- Alcoholism
- Hepatitis
- Hepatitis A
- Hepatitis C
Other Study ID Numbers
- 03-8752-V 03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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