Expanding Access to mTBI Treatment for Veterans and Service Members With Co-occurring Substance Use
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Concussion, Mild Traumatic Brain Injury
- Sponsor
- Shepherd Center, Atlanta GA
- Enrollment
- 360
- Locations
- 1
- Primary Endpoint
- Neurobehavioral Symptom Inventory (NSI)
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Neurobehavioral Symptom Inventory (NSI)
Time Frame: 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)
Time Frame: 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 Outcomes
- Life-Satisfaction Questionnaire -11 (LISAT-11)(Study enrollment, immediately after the intervention, and at 6 months follow-up)
- Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)(Study enrollment, immediately after the intervention, and at 6 months follow-up)
- Patient Health Questionnaire (PHQ-8)(Study enrollment, immediately after the intervention, and at 6 months follow-up)
- Generalized Anxiety Disorder Scale (GAD-7)(Study enrollment, immediately after the intervention, and at 6 months follow-up)
- Repeatable Battery for the Assessment of Neuropsychological Status Update (RBANS Update)(Study enrollment and immediately after the intervention)
- Sensory Organization Test (SOT)(Study enrollment and immediately after the intervention)
- Behavior Rating Inventory of Executive Functioning - Adult Version (BRIEF-A)(Study enrollment and immediately after the intervention)
- Alcohol Use Disorders Identification Test- Concise (AUDIT-C)(Study enrollment and at 6 months follow-up)
- Drug Abuse Screening Test (DAST-10)(Study enrollment and at 6 months follow-up)
- Cannabis Use Disorder Identification Test (CUDIT-R)(Study enrollment and at 6 months follow-up)
- 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)