Clinical trial NCT06620900: Expanding Access to mTBI Treatment for Veterans and Service Members With Co-occurring Substance Use
Official title: Expanding Access to mTBI Treatment for Veterans and Service Members With Co-occurring Substance Use
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Concussion, Mild Traumatic Brain Injury
Brain Injury
Traumatic Brain Injury
Substance Use
Substance Use Disorder (SUD)
Keywords: Concussion
Mild Traumatic Brain Injuty
Brain Injury
Substance use
Substance Use Disorder
Military
Service Members
Veterance
Interdisciplinary
Intensive Outpatient Program
Neurorehabilitation
Lead sponsor: Shepherd Center, Atlanta GA
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Neurobehavioral Symptom Inventory (NSI)
timeFrame: Study enrollment, immediately after the intervention, and at 6 months follow-up
measure: Short Inventory of Problems- Revised (SIP-R)
timeFrame: Study enrollment, immediately after the intervention, and at 6 months follow-up
Secondary outcomes:
measure: Life-Satisfaction Questionnaire -11 (LISAT-11)
timeFrame: Study enrollment, immediately after the intervention, and at 6 months follow-up
measure: Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
timeFrame: Study enrollment, immediately after the intervention, and at 6 months follow-up
measure: Patient Health Questionnaire (PHQ-8)
timeFrame: Study enrollment, immediately after the intervention, and at 6 months follow-up
measure: Generalized Anxiety Disorder Scale (GAD-7)
timeFrame: Study enrollment, immediately after the intervention, and at 6 months follow-up
measure: Repeatable Battery for the Assessment of Neuropsychological Status Update (RBANS Update)
timeFrame: Study enrollment and immediately after the intervention
measure: Sensory Organization Test (SOT)
timeFrame: Study enrollment and immediately after the intervention
measure: Behavior Rating Inventory of Executive Functioning - Adult Version (BRIEF-A)
timeFrame: Study enrollment and immediately after the intervention
measure: Alcohol Use Disorders Identification Test- Concise (AUDIT-C)
timeFrame: Study enrollment and at 6 months follow-up
measure: Drug Abuse Screening Test (DAST-10)
timeFrame: Study enrollment and at 6 months follow-up
measure: Cannabis Use Disorder Identification Test (CUDIT-R)
timeFrame: Study enrollment and at 6 months follow-up
measure: National Survey on Drug Use and Health (NSDUH)- 30-day use: Alcohol and Substances
timeFrame: Study enrollment, immediately after the intervention, and at 6 months follow-up
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Shepherd Center
state: Georgia
Study officials:
References:
citation: Wallace TD, McCauley KL, Hodge AT, Moran TP, Porter ST, Whaley MC, Gore RK. Use of person-centered goals to direct interdisciplinary care for military service members and Veterans with chronic mTBI and co-occurring psychological conditions. Front Neurol. 2022 Nov 16;13:1015591. doi: 10.3389/fneur.2022.1015591. eCollection 2022.