Alcohol Screening, Brief Intervention, and Referral to Treatment in a Military Treatment Facility

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02228967
• Other study ID #: W81XWH-14-2-0014
• Secondary ID: 12019006
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: August 2018

Study information

• Verified date: August 2020
• Source: San Diego State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Deployment frequency and duration and combat exposure are implicated as risk factors for alcohol misuse and PTSD among military personnel. During the past 10 years, Department of Defense healthcare systems have observed steep increases in mental health and substance use services among personnel demobilizing from these conflicts. Although the alcohol Screening, Brief Intervention and Referral to Treatment (SBIRT) approach has shown promise as a low-cost, effective strategy for reducing alcohol use in civilians many of whom are risky drinkers but not yet dependent, it has not been adapted or tested in military health care settings for active duty personnel. This 2.5 year civilian-military collaborative study is highly responsive to exploring solutions to this emerging issue. The specific objectives for the overall project are given below.

Objective 1: Feasibility and Acceptability

• Determine how the SBIRT intervention can be integrated into standard military emergency department (ED) operations by conducting record review and observation of the ED.

• Develop and test the acceptability and usability (for both ED staff and potential participants) of the SBIRT approach by conducting focus groups with active duty personnel and garnering input from ED staff.

• Develop an implementation/operations protocol for delivering SBIRT in the ED.

Objective 2: Adaptation

• Apply a translational research approach to adapt SBIRT implementation in military settings and populations by using information from focus groups and input from ED staff.

• Adapt the content of the SBIRT intervention to be relevant for military personnel, including language and images for counseling and materials using information from focus groups and input from ED staff.

Objective 3: Pilot Trial

• Using a two group repeated measures design, assess the impact of SBIRT using standardized alcohol use measures to assess its potential for effectiveness with active duty military personnel in an ED setting. Specific methodologies include:

• Apply a randomization method in the ED to assign active duty participants to experimental condition.

• Implement the SBIRT intervention in the ED for those assigned to the intervention arm.

• Implement a process for obtaining follow-up data with this mobile population.

• Assess presumed mediators (e.g., readiness/motivation to change and self-efficacy) and moderators (e.g., PTSD status, gender) of alcohol misuse change.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Alcohol Dependency
• Alcoholism

Intervention

Behavioral:
• SBIRT
SBIRT is an "opportunistic" approach whereby patients 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.

Locations

Country	Name	City	State
United States	Naval Medical Center San Diego	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
San Diego State University	United States Naval Medical Center, San Diego

Country where clinical trial is conducted

United States, 

Outcome

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)