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

K

Keming Gao

Status

Completed

Conditions

Alcohol Use

Treatments

Behavioral: Smartphone brief intervention (SP-BI)
Other: Enhanced Usual Care (EUC)

Study type

Interventional

Funder types

Other

Identifiers

NCT02860442
03-16-11
CDMRP-13277015 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

850 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

850 participants in 2 patient groups, including a placebo group

Smartphone brief intervention (SP-BI)
Experimental group
Treatment:
Behavioral: Smartphone brief intervention (SP-BI)
Enhanced Usual Care (EUC)
Placebo Comparator group
Treatment:
Other: Enhanced Usual Care (EUC)

Trial documents
1

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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