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NCT Number: NCT06620900

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

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.

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Key information

Conditions

Concussion, Mild Traumatic Brain Injury Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Brain Injury Central Nervous System Diseases Chemically-Induced Disorders Craniocerebral Trauma Head Injuries, Closed Mental Disorders Nervous System Diseases Substance Use Substance Use Disorder (SUD) Substance-Related Disorders Trauma, Nervous System Traumatic Brain Injury Wounds and Injuries Wounds, Nonpenetrating

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shepherd Center

Atlanta, Georgia, 30309, United States

Location contact

Katherine L McCauley, PhD

CONTACT

[email protected]

404-603-4980

Katherine L McCauley, PhD

SUB_INVESTIGATOR

Russell K Gore, MD

PRINCIPAL_INVESTIGATOR

Tracey D Wallace, MS

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

  2. 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

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  7. 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

  8. 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).

  9. 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

  10. 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

  11. 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 contacts

Contact information is provided by the study sponsor or research team.

Russell K Gore, MD

CONTACT

[email protected]

404-603-4980

Sponsors and collaborators

Lead sponsor

Shepherd Center, Atlanta GA

Other

Registry information

Acronym: ExpandAccess

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Oct 1, 2024
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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