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

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ClinicalTrials.gov Identifier: NCT02228967
Recruitment Status : Completed
First Posted : August 29, 2014
Results First Posted : July 25, 2019
Last Update Posted : July 25, 2019
Sponsor:
Collaborator:
United States Naval Medical Center, San Diego
Information provided by (Responsible Party):
Mark Reed, PhD, San Diego State University

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.

Condition or disease Intervention/treatment Phase
Alcohol Dependency Behavioral: SBIRT Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 791 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Feasibility and Pilot Testing of SBI to Reduce Alcohol Misuse Among Active Duty Members in a Military ER Setting
Actual Study Start Date : August 2015
Actual Primary Completion Date : October 2016
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arm Intervention/treatment
No Intervention: 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.
Active Comparator: 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.
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.
Other Names:
  • Screening
  • Brief Intervention
  • Brief Treatment
  • Referral to Treatment
  • Motivational Interviewing




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02228967


Locations
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United States, California
Naval Medical Center San Diego
San Diego, California, United States, 92134
Sponsors and Collaborators
San Diego State University
United States Naval Medical Center, San Diego
Investigators
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Principal Investigator: Mark Reed, PhD SDSURF - Center for Alcohol & Drug Studies & Services
Principal Investigator: Gerard DeMers, DO United States Naval Medical Center, San Diego

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Responsible Party: Mark Reed, PhD, Director, San Diego State University
ClinicalTrials.gov Identifier: NCT02228967     History of Changes
Other Study ID Numbers: W81XWH-14-2-0014
12019006 ( Other Grant/Funding Number: Congressionally Directed Medical Research Programs )
First Posted: August 29, 2014    Key Record Dates
Results First Posted: July 25, 2019
Last Update Posted: July 25, 2019
Last Verified: May 2019
Keywords provided by Mark Reed, PhD, San Diego State University:
Alcohol Use
SBIRT
Military
Health Behavior
Emergency Room
Health Promotion
Formative Research
Randomized Trial
Additional relevant MeSH terms:
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Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs