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

Shepherd Center, Atlanta GA

Status: Not yet enrolling

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

Treatments: Other: Integrated Model of Care

Study type: Interventional

Funder types: Other

Identifiers

NCT06620900

TP230246 (Other Grant/Funding Number)

2156344

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 360 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

• History of brain injury other than mTBI or progressive neurological disorder
• Active psychosis
• Not able to provide consent

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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360 participants in 1 patient group

Integrated Model of Care

Experimental group

Description:

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.

Treatment:

Other: Integrated Model of Care