Alcohol Dependency Clinical Trial
Official title:
Feasibility and Pilot Testing of SBI to Reduce Alcohol Misuse Among Active Duty Members in a Military ER Setting
Verified date | August 2020 |
Source | San Diego State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
An alcohol Screening, Brief Intervention and Referral to Treatment (SBIRT) approach will be
adapted for use in a large military hospital setting, and then pilot tested in a military
emergency department (ED) to assess its potential for effectiveness and for further testing
in a large-scale trial. SBIRT is an "opportunistic" approach whereby all adult patients in
the ED are screened by Health Educators for their alcohol use, and then, taking advantage of
a "teachable moment," are delivered a brief, motivational intervention matched to their level
of risk.
The feasibility/formative research activities in the first phase (Phase I) of the study are
not summative research, and therefore, do not lend themselves to testable hypotheses.
Hypotheses with regard to the pilot randomized trial in Phase II are as follows:
1. Participants in the SBIRT intervention will show relatively greater reductions over a
six month period (or less increase) than the brochure/usual care control group in the
prevalence of past-month heavy drinking, frequency of heavy drinking, past week number
of drinks, and the AUDIT-based drinkers' index.
2. Alcohol use-related motivation/readiness to change and controlled drinking self-efficacy
will show greater change in the SBIRT intervention group relative to the brochure/usual
care control group.
In addition, exploratory analyses will examine the following:
3. Sociodemographic/military variables (e.g., age, race/ethnicity, gender, branch of
service, officer/enlisted status, PTS) and social-psychological factors (e.g., baseline
readiness to change, self efficacy) will mediate or moderate changes in alcohol misuse.
Status | Completed |
Enrollment | 791 |
Est. completion date | August 2018 |
Est. primary completion date | October 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 18 or Older - Active Duty - Off Duty - Telephone Number for Follow-up - Healthy Enough to Participate - Positive Screen for Risky Drinking Exclusion Criteria: - Under 18 - Non-Military - On Duty - Low Level Drinking |
Country | Name | City | State |
---|---|---|---|
United States | Naval Medical Center San Diego | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
San Diego State University | United States Naval Medical Center, San Diego |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Alcohol Use Disorders Identification Test (AUDIT) Total | The primary outcome measure will come from the participant's total score on the AUDIT. Scores on the AUDIT range from 0 to 40 with higher numbers indicating greater problematic alcohol use. Mean AUDIT scores at follow-up will be compared between arms. | Baseline, Follow-up (Up to 7 months) | |
Secondary | AUDIT-C or Drinkers Index | The drinkers index consists of a summary of the first three AUDIT items which represents a combination of quantity, usual frequency, and frequency of heavy drinking. The AUDIT-C can range from 0 to 12 with 12 representing higher levels of drinking quantity and frequency. | Baseline, Follow-up (Up to 7 months) | |
Secondary | Controlled Drinking Self-Efficacy Scale (CDSES) | The 20-item Controlled Drinking Self-Efficacy Scale (CDSES), is a reliable, valid, easy-to-administer scale that assesses confidence to reduce overall consumption and frequency of drinking. Items range from 0% to 100% with 100% indicating more confidence to engage in controlled drinking. The CDSES was administered at both baseline and follow-up to assess changes in this presumed mediating attitude. | Baseline, Follow-up (Up to 7 months) | |
Secondary | Readiness to Change Scale | A readiness to change alcohol use measure (ranging from 1 - not ready to change, to 4 - very ready) was assessed at baseline and follow-up for all participants. Because motivation and readiness to change are hallmark elements of the SBIRT approach and are thought to be integral to behavior change, these constructs will be measured to assess the degree to which they change in the two groups. Some individuals may not abstain or reduce their use over time, but there may be an improvement in their readiness to change. | Baseline, Follow-up (Up to 7 months) |
Status | Clinical Trial | Phase | |
---|---|---|---|
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