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

NCT06620900 | Not Yet Recruiting

• 2 other identifiers: 2156344TP230246
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Neurobehavioral Symptom Inventory (NSI)

  a 22-item, self-report questionnaire used to measure change in symptoms commonly associated with mild traumatic brain injury over time

  Study enrollment, immediately after the intervention, and at 6 months follow-up

• Short Inventory of Problems- Revised (SIP-R)

  a 17-item self-report inventory used to assess adverse consequences of substance use

  Study enrollment, immediately after the intervention, and at 6 months follow-up

Secondary Outcomes (11)

• 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

Study Arms (1)

Integrated Model of Care

EXPERIMENTAL

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.

Other: Integrated Model of Care

Interventions

Integrated Model of Care OTHER

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.

Integrated Model of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Shepherd Center, Atlanta GA: lead

Study Sites (1)

Shepherd Center

Atlanta, Georgia, 30309, United States

Location

Related Publications (1)

• 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 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Brain Concussion; Brain Injuries; Brain Injuries, Traumatic; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Chemically-Induced Disorders; Mental Disorders

Central Study Contacts

Russell K Gore, MD

CONTACT

404-603-4980; russell.gore@shepherd.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: October 1, 2024
• Study Start: February 1, 2025
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: We will complete upload of IPD by Aug 31, 2025.
• Access Criteria: Researchers can then file an application with FITBIR, following FITBIR processes and protocols, to request access to the data for research purposes.

Locations

US (1)