Project Guard: Reducing Alcohol Misuse/Abuse in the National Guard



Status:Recruiting
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:Any
Updated:3/31/2019
Start Date:March 1, 2017
End Date:June 2020
Contact:Carla Conroy, MPH
Email:carla.conroy@UHhospitals.org
Phone:216/844-2871

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Early Intervention to Reduce Alcohol Misuse and Abuse in the Ohio Army National Guard

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.

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 OHARNGMHI
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 screen ~
3,100 individuals over the three year enrollment period to identify 750 participants 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 3 -, 6- 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.

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 still be a current or former member of the Ohio National Guard (i.e. they have
not retired or separated from the ONG).

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
We found this trial at
2
sites
Cleveland, Ohio 44012
Principal Investigator: Joseph Calabrese, MD
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Cleveland, OH
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2801 W. Bancroft
Toledo, Ohio 43606
419.530.4636
Principal Investigator: John Wryobeck, PhD
University of Toledo The University of Toledo is one of 14 state universities in Ohio....
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Toledo, OH
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