Project Guard: Reducing Alcohol Misuse/Abuse in the National Guard
Primary Purpose
Alcohol Use
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Smartphone brief intervention (SP-BI)
Enhanced Usual Care (EUC)
Sponsored by

About this trial
This is an interventional supportive care trial for Alcohol Use focused on measuring Alcohol misuse, Smartphone app, Screening, Brief Intervention, Referral to Treatment (SBIRT)
Eligibility Criteria
Inclusion Criteria:
- Have a past 4-month AUDIT-C score of 5 or more for men and 4 or more for women indicating that they meet criteria for at-risk drinking, AND
- Do not meet any of the exclusion criteria.
- Must be a current or former member of the Ohio Army National Guard (OHARNG) or U.S. Army Reserve based in Ohio.
Exclusion Criteria:
- Those who do not have access to a smart phone with either Android or iOS operating system
- Those in active treatment for substance use disorders (i.e., report addictions treatment in past 4 months) will be excluded because the proposed SBIRT intervention is focused on early brief intervention for those with at-risk drinking and on referral to treatment for those with more serious problems
Sites / Locations
- University Hospitals Cleveland Medical Center
- University of Toledo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Smartphone brief intervention (SP-BI)
Enhanced Usual Care (EUC)
Arm Description
Outcomes
Primary Outcome Measures
Change in the Number of Drinking Days as Assessed by the Audit-C
Change in the Number of Drinks per Day as Assessed by the Audit-C
Change in the Number of Binge Drinking Days as Assessed by the Audit-C
Secondary Outcome Measures
Full Information
NCT ID
NCT02860442
First Posted
June 7, 2016
Last Updated
September 28, 2021
Sponsor
Keming Gao
Collaborators
Case Western Reserve University, University of Michigan, University of Toledo Health Science Campus
1. Study Identification
Unique Protocol Identification Number
NCT02860442
Brief Title
Project Guard: Reducing Alcohol Misuse/Abuse in the National Guard
Official Title
Early Intervention to Reduce Alcohol Misuse and Abuse in the Ohio Army National Guard
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
May 31, 2021 (Actual)
Study Completion Date
May 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Keming Gao
Collaborators
Case Western Reserve University, University of Michigan, University of Toledo Health Science Campus
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The overall goal for the study is to test the efficacy of a smartphone app which includes an alcohol brief intervention (SP-BI) versus an Enhanced Usual Care (EUC) condition for National Guard members in the State of Ohio who meet criteria for at-risk drinking in the previous 4 months. The main hypothesis is that those in the SP-BI group with have reduced frequency and intensity of at-risk drinking and fewer binge drinking episodes.
Detailed Description
The project is a fully-powered randomized controlled trial of a smartphone app which includes an alcohol brief intervention (SP-BI) versus an Enhanced Usual Care (EUC) condition for National Guard members in the State of Ohio, who are already participating in the Ohio Army National Guard Mental Health Initiative (OHARNG-MHI) study, titled "Resilience and Risk Factors Associated with Deployment Related Posttraumatic Psychopathology", who meet criteria for at-risk drinking in the previous 4 months. After tailoring the content of the SP-BI intervention for NG soldiers, the study will prescreen ~ 8,500 individuals over the three year enrollment period to identify 850participants with at-risk drinking. TParticipants in this study will be randomized to either the SP-BI (n=375) or the EUC condition (n=375) and followed at 4, 8 and 12 months post-enrollment. Participants who are randomized to the SP-BI condition will receive an informational brochure with resources available to members of the military related to mental health and alcohol use and will download a free app on to their smartphones. The app will be developed to be used on both Android and iPhone platforms and will be used over 12 weeks to deliver the study intervention. Those assigned to the EUC condition will receive the informational brochure only.
The specific aims of the study are to compare SP-BI and EUC in: 1) Reducing the frequency and intensity of at-risk drinking at 4 -, 8- and 12-months; 2) Decreasing binge drinking at 4-, 8- and 12 months. The secondary aims are to: 1) Compare the SP-BI and EUC conditions in reducing the frequency of illicit drug use and depressive symptoms at 4-, 8- and 12-months; 2) Examine if deployment status moderates the effect of intervention assignment (SP-BI or EUC) on post-intervention drinking, depressed feelings, and other substance use.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use
Keywords
Alcohol misuse, Smartphone app, Screening, Brief Intervention, Referral to Treatment (SBIRT)
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
850 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Smartphone brief intervention (SP-BI)
Arm Type
Experimental
Arm Title
Enhanced Usual Care (EUC)
Arm Type
Placebo Comparator
Intervention Type
Behavioral
Intervention Name(s)
Smartphone brief intervention (SP-BI)
Intervention Description
Participants in the SP-BI group will receive a 20-30 minute intervention through an app program based on the FRAMES format: providing personalized Feedback (regarding substance use, risk factors), emphasis on Responsibility for change, Advice, Menu of options, Empathic clinical behaviors, and support of Self-efficacy regarding making changes. The intervention is designed to address the target behavior of alcohol use, and will include a tailored review of participants' goals/values, feedback regarding their alcohol use patterns and consequences (either actual experiences or potential based on risk behaviors), developing a discrepancy between their alcohol use and ability to meet goals and values through a decisional balance exercise, and formulation of a "change plan".
Intervention Type
Other
Intervention Name(s)
Enhanced Usual Care (EUC)
Intervention Description
Those assigned to EUC will receive an informational brochure with resources available to members of the military related to mental health and alcohol use. They will be contacted to complete 4-, 8-, and 12-month follow-up assessments.
Primary Outcome Measure Information:
Title
Change in the Number of Drinking Days as Assessed by the Audit-C
Time Frame
Change over time (Baseline, 4-, 8- and 12-months post baseline)
Title
Change in the Number of Drinks per Day as Assessed by the Audit-C
Time Frame
Change over time (Baseline, 4-, 8- and 12-months post baseline)
Title
Change in the Number of Binge Drinking Days as Assessed by the Audit-C
Time Frame
Change over time (Baseline, 4-, 8- and 12-months post baseline)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have a past 4-month AUDIT-C score of 5 or more for men and 4 or more for women indicating that they meet criteria for at-risk drinking, AND
Do not meet any of the exclusion criteria.
Must be a current or former member of the Ohio Army National Guard (OHARNG) or U.S. Army Reserve based in Ohio.
Exclusion Criteria:
Those who do not have access to a smart phone with either Android or iOS operating system
Those in active treatment for substance use disorders (i.e., report addictions treatment in past 4 months) will be excluded because the proposed SBIRT intervention is focused on early brief intervention for those with at-risk drinking and on referral to treatment for those with more serious problems
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederic C Blow, PhD
Organizational Affiliation
Department of Psychiatry, University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
University of Toledo
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Project Guard: Reducing Alcohol Misuse/Abuse in the National Guard
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