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

NCT ID: NCT02228967

Last Updated: 2020-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 791 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2018-08-31

Brief 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.

Detailed 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.

Conditions

Alcohol Dependency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Usual Care

Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time.

Group Type: NO_INTERVENTION

No interventions assigned to this group

SBIRT

Those assigned to the SBIRT intervention group will receive 1 of 3 tracks:

1. Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies.

2. Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone.

3. Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support.

Group Type: ACTIVE_COMPARATOR

SBIRT

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Screening; Brief Intervention; Brief Treatment; Referral to Treatment; Motivational Interviewing

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

United States Naval Medical Center, San Diego

FED

Sponsor Role: collaborator

San Diego State University

OTHER

Sponsor Role: lead

Responsible Party

Mark Reed, PhD

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mark Reed, PhD

Role: PRINCIPAL_INVESTIGATOR

SDSURF - Center for Alcohol & Drug Studies & Services

Gerard DeMers, DO

Role: PRINCIPAL_INVESTIGATOR

United States Naval Medical Center, San Diego

Locations

Naval Medical Center San Diego

San Diego, California, United States

Countries

United States

Other Identifiers

12019006

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

W81XWH-14-2-0014

Identifier Type: -

Identifier Source: org_study_id