Health Behavior Feedback Study for Veterans With Hepatitis C
Condition: Alcoholism; Alcohol Abuse; Hepatitis C; Liver Disease
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis; Liver Diseases; Alcoholism
Study type: Interventional
Phase: Phase 1

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.
    

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.
    

Intervention name(s): 3 session brief intervention with health behavior feedback; treatment as usual
Intervention type(s): Behavioral; Other
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Brief Intervention; Motivational Interviewing; Health Psychology; Alcohol; Hepatitis C; Patient Education