Project Guard: Reducing Alcohol Misuse/Abuse in the National Guard
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|ClinicalTrials.gov Identifier: NCT02860442|
Recruitment Status : Active, not recruiting
First Posted : August 9, 2016
Last Update Posted : March 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|Alcohol Use||Behavioral: Smartphone brief intervention (SP-BI) Other: Enhanced Usual Care (EUC)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||850 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Early Intervention to Reduce Alcohol Misuse and Abuse in the Ohio Army National Guard|
|Actual Study Start Date :||March 1, 2017|
|Estimated Primary Completion Date :||February 2021|
|Estimated Study Completion Date :||February 2021|
|Experimental: Smartphone brief intervention (SP-BI)||
Behavioral: Smartphone brief intervention (SP-BI)
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".
|Placebo Comparator: Enhanced Usual Care (EUC)||
Other: Enhanced Usual Care (EUC)
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.
- 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) ]
- 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) ]
- 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) ]
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): NCT02860442
|United States, Ohio|
|University Hospitals Cleveland Medical Center|
|Cleveland, Ohio, United States, 44106|
|University of Toledo|
|Toledo, Ohio, United States, 43614|
|Principal Investigator:||Frederic C Blow, PhD||Department of Psychiatry, University of Michigan|