MiSSION STRONG - Preventing AOS Misuse in the National Guard

NCT ID: NCT02181283

Last Updated: 2018-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

757 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2018-05-31

Brief Summary

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National Guard members, especially those who have been combat-deployed, are at high risk for developing alcohol- and prescription-related drug problems. The use of novel Web-based interventions combined with either Web-based boosters or Peer support sessions, may have a major public health impact for the National Guard by reducing hazardous use of alcohol of prescription drugs. The aims of the study are to develop, refine and test tailored motivational Brief Interventions (BIs) with varied continuing booster reinforcements (Web vs. Peer) and to conduct a randomized controlled trial comparing the efficacy of these BIs (W+W; W+P) to usual care on subsequent alcohol/drug consumption and consequences, including injury, mental and physical-health functioning, and HIV risk behaviors at 4-, 8-, and 12-months post-enrollment.

Detailed Description

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The proposed study will test the efficacy of an easy-to-use, \<40-minute, state-of-the-art tailored Web-based SBIRT (Screening, Brief Intervention, and Referral to Treatment) intervention combined with subsequent Web- or Peer-based boosters, compared to enhanced usual care (EUC). All participants will also receive a booklet with prevention information that includes general alcohol, opioid, and sedative use information as well as other health behaviors. The proposed study will screen \~ 4,300 unique Service Members as part of Soldier Readiness Processing in the Michigan National Guard (NG) to enroll 750 participants within 35 armories with alcohol and/or prescribed opioid or sedative misuse (AOS misuse). We will identify AOS misuse with a combination of the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) and an adapted version of the Pain Medication Questionnaire (PMQ). Computerized screening with touch-screen computer tablets will be used to recruit NG Service Members with AOS misuse in the prior 4 months. Participants will be randomized to one of three conditions:1) Web-delivered alcohol/prescribed drug misuse brief intervention with Web booster sessions (1/month for 3 months; W+W; n=250); 2) Web-delivered brief intervention with Peer-delivered booster sessions (at least 1/month for 3 months; W+P; n=250); or 3) Enhanced Usual Care (EUC; n=250). Random assignment will be stratified by gender and alcohol vs. prescription opioid/sedative misuse.

Conditions

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AOD Misuse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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W+W

Web-delivered alcohol/prescribed drug misuse brief intervention with Web booster sessions (W+W).

Group Type ACTIVE_COMPARATOR

W+W

Intervention Type BEHAVIORAL

Web-delivered brief intervention: Participants receive a 30-40 minute Web-based intervention which includes a tailored review of participants' goals/values, feedback regarding their present alcohol/prescribed opioid/sedative use patterns and consequences, developing a discrepancy between their alcohol or prescribed drug use, ability to meet goals and values through a decisional balance exercise, and formulation of a tailored "change plan".

Web booster sessions: Web boosters will be completed at 1, 2 and 3 months post-BI. Content is tailored to the individual based on answers to baseline questions and responses during Web-based BI. Web-based Booster will: 1) briefly ascertain current AOS use, 2) changes in AOS since completing Web BI, 3) progress toward goals, and 4) plans and encouragement for next steps.

W+P

Web-delivered brief intervention with Peer-delivered booster sessions (W+P).

Group Type ACTIVE_COMPARATOR

W+P

Intervention Type BEHAVIORAL

Web-delivered brief intervention: Participants receive a 30-40 minute Web-based intervention which includes a tailored review of participants' goals/values, feedback regarding their present alcohol/prescribed opioid/sedative use patterns and consequences, developing a discrepancy between their alcohol or prescribed drug use, ability to meet goals and values through a decisional balance exercise, and formulation of a tailored "change plan".

Peer booster sessions: The peer supporter will work with participants at 1, 2, and 3 months post-Web-based BI. Peer supports will address Service Members' own goals and will provide emotional and informational support.

Enhanced Usual Care

Enhanced usual care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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W+W

Web-delivered brief intervention: Participants receive a 30-40 minute Web-based intervention which includes a tailored review of participants' goals/values, feedback regarding their present alcohol/prescribed opioid/sedative use patterns and consequences, developing a discrepancy between their alcohol or prescribed drug use, ability to meet goals and values through a decisional balance exercise, and formulation of a tailored "change plan".

Web booster sessions: Web boosters will be completed at 1, 2 and 3 months post-BI. Content is tailored to the individual based on answers to baseline questions and responses during Web-based BI. Web-based Booster will: 1) briefly ascertain current AOS use, 2) changes in AOS since completing Web BI, 3) progress toward goals, and 4) plans and encouragement for next steps.

Intervention Type BEHAVIORAL

W+P

Web-delivered brief intervention: Participants receive a 30-40 minute Web-based intervention which includes a tailored review of participants' goals/values, feedback regarding their present alcohol/prescribed opioid/sedative use patterns and consequences, developing a discrepancy between their alcohol or prescribed drug use, ability to meet goals and values through a decisional balance exercise, and formulation of a tailored "change plan".

Peer booster sessions: The peer supporter will work with participants at 1, 2, and 3 months post-Web-based BI. Peer supports will address Service Members' own goals and will provide emotional and informational support.

Intervention Type BEHAVIORAL

Other Intervention Names

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Web-delivered brief intervention with Web booster sessions Web-delivered brief intervention with Peer-delivered booster sessions

Eligibility Criteria

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Inclusion Criteria

Individuals will be eligible to participate if they are in the Michigan Army National Guard and their unit is selected to participate in the proposed study. Individuals will be eligible to participate in the randomized trial if they:

* have an AUDIT-C score of 5 or more for men and 4 or more for women in the prior 4 months, indicating that they meet criteria for at-risk drinking/alcohol misuse; and/or
* use of prescribed opioids or sedatives in the prior 4 months in a manner that was inconsistent with their prescribed course of treatment (medical misuse: determined by items from an adapted PMQ).

Exclusion Criteria

* under 18 years of age
* inability to speak and understand English
* inability to give informed, voluntary consent
* do not have access to the Web (e.g. home, work, library, WiFi-enabled tablet PCs (iPad), etc.)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Frederic C. Blow

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Frederic C Blow, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

References

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Blow FC, Walton M, Ilgen M, Ignacio RV, Walters H, Massey L, Barry KL, McCormick R, Coughlin LN. Peer- and web-based interventions for risky drinking among US National Guard members: Mission Strong randomized controlled trial. Addiction. 2023 Jul;118(7):1246-1257. doi: 10.1111/add.16172. Epub 2023 Apr 11.

Reference Type DERIVED
PMID: 37041669 (View on PubMed)

Coughlin LN, Blow FC, Walton M, Ignacio RV, Walters H, Massey L, Barry KL, McCormick R. Predictors of Booster Engagement Following a Web-Based Brief Intervention for Alcohol Misuse Among National Guard Members: Secondary Analysis of a Randomized Controlled Trial. JMIR Ment Health. 2021 Oct 26;8(10):e29397. doi: 10.2196/29397.

Reference Type DERIVED
PMID: 34698652 (View on PubMed)

Other Identifiers

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1R01AA023122-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AA023122

Identifier Type: -

Identifier Source: org_study_id

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