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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02860442
Recruitment Status : Active, not recruiting
First Posted : August 9, 2016
Last Update Posted : March 5, 2020
Sponsor:
Collaborators:
Case Western Reserve University
University of Michigan
University of Toledo Health Science Campus
Information provided by (Responsible Party):
Joseph Calabrese, MD, University Hospitals Cleveland Medical Center

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.

Condition or disease Intervention/treatment Phase
Alcohol Use Behavioral: Smartphone brief intervention (SP-BI) Other: Enhanced Usual Care (EUC) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 850 participants
Allocation: Randomized
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

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. 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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT02860442


Locations
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United States, Ohio
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
University of Toledo
Toledo, Ohio, United States, 43614
Sponsors and Collaborators
Joseph Calabrese, MD
Case Western Reserve University
University of Michigan
University of Toledo Health Science Campus
Investigators
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Principal Investigator: Frederic C Blow, PhD Department of Psychiatry, University of Michigan
  Study Documents (Full-Text)

Documents provided by Joseph Calabrese, MD, University Hospitals Cleveland Medical Center:
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Responsible Party: Joseph Calabrese, MD, Director, Mood Disorders Program, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT02860442    
Other Study ID Numbers: 03-16-11
CDMRP-13277015 ( Other Grant/Funding Number: U.S. Army Medical Research and Materiel Command )
First Posted: August 9, 2016    Key Record Dates
Last Update Posted: March 5, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Joseph Calabrese, MD, University Hospitals Cleveland Medical Center:
Alcohol misuse
Smartphone app
Screening, Brief Intervention, Referral to Treatment (SBIRT)
Additional relevant MeSH terms:
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Alcohol Drinking
Drinking Behavior