Expanding Access to mTBI Treatment for Veterans and Service Members With Co-occurring Substance Use
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Integrated Model of Care.
- Who it may be relevant to
- Registry conditions: Concussion, Mild Traumatic Brain Injury, Brain Injury, Traumatic Brain Injury, Substance Use. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other 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.
Primary outcome measures
- Neurobehavioral Symptom Inventory (NSI) [Time frame: Study enrollment, immediately after the intervention, and at 6 months follow-up]
- Short Inventory of Problems- Revised (SIP-R) [Time frame: Study enrollment, immediately after the intervention, and at 6 months follow-up]
Secondary outcome measures (11)
- Life-Satisfaction Questionnaire -11 (LISAT-11) [Time frame: Study enrollment, immediately after the intervention, and at 6 months follow-up]
- Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) [Time frame: Study enrollment, immediately after the intervention, and at 6 months follow-up]
- Patient Health Questionnaire (PHQ-8) [Time frame: Study enrollment, immediately after the intervention, and at 6 months follow-up]
- Generalized Anxiety Disorder Scale (GAD-7) [Time frame: Study enrollment, immediately after the intervention, and at 6 months follow-up]
- Repeatable Battery for the Assessment of Neuropsychological Status Update (RBANS Update) [Time frame: Study enrollment and immediately after the intervention]
- Sensory Organization Test (SOT) [Time frame: Study enrollment and immediately after the intervention]
- Behavior Rating Inventory of Executive Functioning - Adult Version (BRIEF-A) [Time frame: Study enrollment and immediately after the intervention]
- Alcohol Use Disorders Identification Test- Concise (AUDIT-C) [Time frame: Study enrollment and at 6 months follow-up]
- Drug Abuse Screening Test (DAST-10) [Time frame: Study enrollment and at 6 months follow-up]
- Cannabis Use Disorder Identification Test (CUDIT-R) [Time frame: Study enrollment and at 6 months follow-up]
- National Survey on Drug Use and Health (NSDUH)- 30-day use: Alcohol and Substances [Time frame: Study enrollment, immediately after the intervention, and at 6 months follow-up]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Shepherd Center — Atlanta
Publications
- 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. PMID 36523344
Identifiers
NCT: NCT06620900 · 2156344 · TP230246