Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2026-02-22 @ 2:56 AM
Study NCT ID:
NCT02228967
Status:
COMPLETED
Last Update Posted:
2020-09-09
First Post:
2014-08-26
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Alcohol Screening, Brief Intervention, and Referral to Treatment in a Military Treatment Facility
Sponsor:
San Diego State University
Organization:
Study Overview
Official Title:
Feasibility and Pilot Testing of SBI to Reduce Alcohol Misuse Among Active Duty Members in a Military ER Setting
Status:
COMPLETED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 12019006 | OTHER_GRANT | Congressionally Directed Medical Research Programs | View |