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Completed

NCT Number: NCT02228967

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

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.

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Key information

Conditions

Alcohol Dependency Alcohol Drinking Alcohol-Related Disorders Alcoholism Behavior Chemically-Induced Disorders Disease Attributes Drinking Behavior Emergencies Health Behavior Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Naval Medical Center San Diego

San Diego, California, 92134, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SBIRT

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.

Other names: Screening, Brief Intervention, Brief Treatment, Referral to Treatment, Motivational Interviewing

Primary outcomes

  1. Alcohol Use Disorders Identification Test (AUDIT) Total

    Time frame: Baseline, Follow-up (Up to 7 months)

    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.

Secondary outcomes

  1. AUDIT-C or Drinkers Index

    Time frame: Baseline, Follow-up (Up to 7 months)

    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.

  2. Controlled Drinking Self-Efficacy Scale (CDSES)

    Time frame: Baseline, Follow-up (Up to 7 months)

    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.

  3. Readiness to Change Scale

    Time frame: Baseline, Follow-up (Up to 7 months)

    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.

Sponsors and collaborators

Lead sponsor

San Diego State University

Other

Collaborators

  • United States Naval Medical Center, San Diego

Registry information

Official study title

Feasibility and Pilot Testing of SBI to Reduce Alcohol Misuse Among Active Duty Members in a Military ER Setting

Important dates

Study start
2015
Primary completion
2016
Study completion
2018
First posted
Aug 29, 2014
Registry last updated
Sep 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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