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AlcoholismPhase 1NCT00229580

Health Behavior Feedback Study for Veterans With Hepatitis C

A Phase 1 study testing 3 session brief intervention with health behavior feedback and treatment as usual in people with Alcoholism and Alcohol Abuse, run by University of Washington at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Alcoholism, Alcohol Abuse, Hepatitis C
What is being tested?
3 session brief intervention with health behavior feedback and treatment as usual
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
Dec 2003to Jan 2006
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • VA Puget Sound Health Care System

    Seattle, Washington, 98108

Other trials in United States

About this study

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.

Read the 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.

Being tested
3 session brief intervention with health behavior feedback, treatment as usual
Keywords
Brief Intervention, Motivational Interviewing, Health Psychology, Alcohol, Hepatitis C, Patient Education
Medical subject headings
Alcoholism, Hepatitis C, Liver Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3 session brief intervention with health behavior feedbackBehavioural

  • treatment as usualOther

Study groups in NCT00229580
Study groupRoleWhat they receive
1ExperimentalMotivational feedback
Receives: Behavioral: 3 session brief intervention with health behavior feedback
2Active comparatortreatment as usual
Receives: Other: treatment as usual

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reduction in alcohol consumption

    Measured: at 6 and 12-week follow-up.

Secondary outcomes (1)
  1. Engagement in substance use treatment and hepatitis C specialty care. Detection of elevated CDT in blood serum compared with self-reported heavy drinking.

    Measured: 12 weeks post-study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2005 (estimated)
  2. Study startDec 2003
  3. Study completionJan 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00229580
Sponsor's protocol ID
03-8752-V 03
Status last verified
Nov 2007
First submitted
27 Sep 2005
Last updated
30 Nov 2007
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 3 session brief intervention with health behavior feedback and treatment as usual in people with Alcoholism and Alcohol Abuse, run by University of Washington at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduction in alcohol consumption (time frame: at 6 and 12-week follow-up.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2007.

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