NCT02860442

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
850

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 9, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

March 1, 2017

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
Last Updated

September 29, 2021

Status Verified

September 1, 2021

Enrollment Period

4.3 years

First QC Date

June 7, 2016

Last Update Submit

September 28, 2021

Conditions

Alcohol Use

Keywords

Alcohol misuseSmartphone appScreening, Brief Intervention, Referral to Treatment (SBIRT)

Outcome Measures

Primary Outcomes (3)

  • Change in the Number of Drinking Days as Assessed by the Audit-C

    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

    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

    Change over time (Baseline, 4-, 8- and 12-months post baseline)

Study Arms (2)

Smartphone brief intervention (SP-BI)

EXPERIMENTAL
Behavioral: Smartphone brief intervention (SP-BI)

Enhanced Usual Care (EUC)

PLACEBO COMPARATOR
Other: Enhanced Usual Care (EUC)

Interventions

Smartphone brief intervention (SP-BI)BEHAVIORAL

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".

Smartphone brief intervention (SP-BI)
Enhanced Usual Care (EUC)OTHER

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.

Enhanced Usual Care (EUC)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Must be a current or former member of the Ohio Army National Guard (OHARNG) or U.S. Army Reserve based in Ohio.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

University of Toledo

Toledo, Ohio, 43614, United States

Location

MeSH Terms

Conditions

Alcohol Drinking

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Study Officials

  • Frederic C Blow, PhD

    Department of Psychiatry, University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director, Mood Disorders Program

Study Record Dates

First Submitted

June 7, 2016

First Posted

August 9, 2016

Study Start

March 1, 2017

Primary Completion

May 31, 2021

Study Completion

May 31, 2021

Last Updated

September 29, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

US(2)