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

Not Applicable

Not yet recruiting

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

• Registration Number: NCT06620900
• Lead Sponsor: Shepherd Center, Atlanta GA

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.

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-23
• Study First Submitted QC: 2024-09-26
• Last Update Submitted: 2024-09-26
• Study First Posted: 2024-10-01
• Last Update Posted: 2024-10-01
• Study Start: 2025-02
• Primary Completion: 2028-08
• Study Completion: 2028-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 360

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Neurobehavioral Symptom Inventory (NSI)	Study enrollment, immediately after the intervention, and at 6 months follow-up	a 22-item, self-report questionnaire used to measure change in symptoms commonly associated with mild traumatic brain injury over time
Short Inventory of Problems- Revised (SIP-R)	Study enrollment, immediately after the intervention, and at 6 months follow-up	a 17-item self-report inventory used to assess adverse consequences of substance use

Secondary Outcome Measures

Name	Time	Method
Life-Satisfaction Questionnaire -11 (LISAT-11)	Study enrollment, immediately after the intervention, and at 6 months follow-up	an internationally validated 11-item self-report inventory of satisfaction within important life domains: life as a whole, vocational situation, financial situation, leisure situation, contacts with friends, sexual life, self-care management, family life, partner, physical health, and psychological health
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)	Study enrollment, immediately after the intervention, and at 6 months follow-up	a 20-item self-report inventory used to assess severity of posttraumatic stress symptoms and monitoring symptom change during and after treatment
Patient Health Questionnaire (PHQ-8)	Study enrollment, immediately after the intervention, and at 6 months follow-up	an eight item, self-report inventory used to screen for the presence and severity of depression
Generalized Anxiety Disorder Scale (GAD-7)	Study enrollment, immediately after the intervention, and at 6 months follow-up	a seven item, self-report inventory used to screen for the presence and severity of anxiety
Repeatable Battery for the Assessment of Neuropsychological Status Update (RBANS Update)	Study enrollment and immediately after the intervention	a multi-item, multi-subtest, clinician administered objective assessment used to measure change over time in neuropsychological status by yielding a Total Score, as well as Immediate Memory, Delayed Memory, Attention, Language, and Visuospatial/ Constructional scores
Sensory Organization Test (SOT)	Study enrollment and immediately after the intervention	completed as part of quantitative Balance Testing (Bertec) which provides information about postural stability by measuring subject sway on a force platform under different sensory conditions; the SOT is used to evaluate sensory weighting in postural control using a series of conditions of increased difficulty.
Behavior Rating Inventory of Executive Functioning - Adult Version (BRIEF-A)	Study enrollment and immediately after the intervention	a 75-item self-report inventory of executive functioning in everyday environments that yields a total Global Executive Composite score as well as a Behavioral Regulation Index and Metacognitive Index
Alcohol Use Disorders Identification Test- Concise (AUDIT-C)	Study enrollment and at 6 months follow-up	a three-item, self-report screening tool used to identify people who with active alcohol use disorders (including alcohol abuse or dependence).
Drug Abuse Screening Test (DAST-10)	Study enrollment and at 6 months follow-up	a 10-item self-report instrument that yields a quantitative index of the degree of consequences related to drug use
Cannabis Use Disorder Identification Test (CUDIT-R)	Study enrollment and at 6 months follow-up	an 8-item measure designed for screening for problematic cannabis use and use a brief repeated outcome measure
National Survey on Drug Use and Health (NSDUH)- 30-day use: Alcohol and Substances	Study enrollment, immediately after the intervention, and at 6 months follow-up	survey of alcohol use (tallying days used and estimating average number of drinks per drinking day) and additional substances used (number of days used)

Trial Locations

Locations (1)

Shepherd Center; 🇺🇸 Atlanta, Georgia, United States