Hepatitis C Clinical Trial
Official title:
Health Behavior Feedback Study for Veterans With Hepatitis C
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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