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

September 26, 2024 updated by: Shepherd Center, Atlanta GA

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

360

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Shepherd Center
        • Contact:
        • Principal Investigator:
          • Russell K Gore, MD
        • Sub-Investigator:
          • Katherine L McCauley, PhD
        • Sub-Investigator:
          • Tracey D Wallace, MS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Integrated Model of Care
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Life-Satisfaction Questionnaire -11 (LISAT-11)
Time Frame: 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
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
a 20-item self-report inventory used to assess severity of posttraumatic stress symptoms and monitoring symptom change during and after treatment
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
an eight item, self-report inventory used to screen for the presence and severity of depression
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
a seven item, self-report inventory used to screen for the presence and severity of anxiety
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
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
Study enrollment and immediately after the intervention
Sensory Organization Test (SOT)
Time Frame: 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.
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
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
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
a three-item, self-report screening tool used to identify people who with active alcohol use disorders (including alcohol abuse or dependence).
Study enrollment and at 6 months follow-up
Drug Abuse Screening Test (DAST-10)
Time Frame: 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
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
an 8-item measure designed for screening for problematic cannabis use and use a brief repeated outcome measure
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
survey of alcohol use (tallying days used and estimating average number of drinks per drinking day) and additional substances used (number of days used)
Study enrollment, immediately after the intervention, and at 6 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shepherd Center, Atlanta GA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2025

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2028

Study Registration Dates

First Submitted

September 23, 2024

First Submitted That Met QC Criteria

September 26, 2024

First Posted (Actual)

October 1, 2024

Study Record Updates

Last Update Posted (Actual)

October 1, 2024

Last Update Submitted That Met QC Criteria

September 26, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2156344
  • TP230246 (Other Grant/Funding Number: Department of Defense)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We will submit de-identified research data into the Federal Interagency TBI Research (FITBIR) Informatics System at the completion of the clinical trial. The following data will be collected and reported the following National Institute of Neurological Disorders and Stroke (NINDS) TBI common data elements (CDE) as part of this process:

  • Demographics and Injury Characteristics
  • Neurobehavioral Symptom Inventory (NSI)
  • Alcohol Use Disorders Identification Test-Concise (AUDIT-C)
  • Patient Health Questionnaire (8 Item) (PHQ-8)
  • Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
  • Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A)
  • Life-Satisfaction Questionnaire -11 (LISAT-11)
  • Sensory Organization Test (SOT)
  • Short Inventory of Problems- Revised (SIP-R)
  • Drug Abuse Screening Test (DAST-10)
  • Cannabis Use Disorder Identification Test (CUDIT-R)
  • National Survey on Drug Use and Health (NSDUH)- 30-day use: Alcohol and Substances

IPD Sharing Time Frame

We will complete upload of IPD by Aug 31, 2025.

IPD Sharing Access Criteria

Researchers can then file an application with FITBIR, following FITBIR processes and protocols, to request access to the data for research purposes.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Brain Injury

Clinical Trials on Integrated Model of Care

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belarus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe