Expanding Access to mTBI Treatment for Veterans and Service Members With Co-occurring Substance Use

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-28

Study Completion Date

2028-08-31

Brief Summary

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The purpose of this research is to determine whether military veterans and service members with mild traumatic brain injury with and without co-occurring substance use can complete and benefit from integrated interdisciplinary care individualized to their symptoms, goals, and needs.

Participants will complete surveys about substance use and other symptoms at the beginning and end of treatment in an intensive outpatient program and 6 months after discharge.

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Detailed Description

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This pragmatic clinical trial will (1) assess treatment retention and treatment outcomes at the completion of interdisciplinary intensive outpatient program (IOP) and at a 6-month follow-up comparing service members and veterans (SM/Vs) with mild traumatic brain injury (mTBI) + substance use (SU) and a TBI -control group; and (2) assess SU-related outcomes at the end of IOP treatment and durability of SU outcomes at 6-months follow-up among SM/Vs with co-occurring SU. Analyses of these key treatment outcomes along with input from lived experience consultants and other key stakeholders, will be used to refine and disseminate a scalable approach to treating individuals with mTBI and co-occurring SU.

Conditions

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Concussion, Mild Traumatic Brain Injury Brain Injury Traumatic Brain Injury Substance Use Substance Use Disorder (SUD)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Integrated Model of Care

Participants will engage in interdisciplinary intensive outpatient program (IOP) treatment for mild traumatic brain injury with individualized support for substance use (SU) following which they will receive support for SU in the transition support program.

Group Type EXPERIMENTAL

Integrated Model of Care

Intervention Type OTHER

The Integrated Model of Care was developed and piloted by the study team provide support for individuals seeking care in an interdisciplinary intensive outpatient program for mild traumatic brain injury to receive support for co-occurring substance use-related needs.

Interventions

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Integrated Model of Care

The Integrated Model of Care was developed and piloted by the study team provide support for individuals seeking care in an interdisciplinary intensive outpatient program for mild traumatic brain injury to receive support for co-occurring substance use-related needs.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* At least 18 years of age
* US military service member or veteran
* Diagnosis of mild traumatic brain injury (mTBI) and/or repetitive head impact/blast exposures
* Participating in the SHARE Military Initiative intensive outpatient program