Concussion, Mild Traumatic Brain InjuryExpandAccessNCT06620900
Expanding Access to mTBI Treatment for Veterans and Service Members With Co-occurring Substance Use
A study testing Integrated Model of Care in people with Concussion, Mild Traumatic Brain Injury and Brain Injury, run by Shepherd Center, Atlanta GA at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Concussion, Mild Traumatic Brain Injury, Brain Injury, Traumatic Brain Injury
- What is being tested?
- Integrated Model of Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2025to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- History of brain injury other than mTBI or progressive neurological disorder
- Active psychosis
- Not able to provide consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Shepherd Center
Atlanta, Georgia, 30309
Katherine L McCauley, PhD, 404-603-4980, katherine.mccauley@shepherd.org
Russell K Gore, MD
About this study
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.
Read the 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.
- Conditions
- Concussion, Mild Traumatic Brain Injury, Brain Injury, Traumatic Brain Injury, Substance Use, Substance Use Disorder (SUD)
- Being tested
- Integrated Model of Care
- Keywords
- Concussion, Mild Traumatic Brain Injuty, Brain Injury, Substance use, Substance Use Disorder, Military, Service Members, Veterance, Interdisciplinary, Intensive Outpatient Program, Neurorehabilitation
- Medical subject headings
- Brain Concussion, Brain Injuries, Brain Injuries, Traumatic, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Model of CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Integrated Model of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Study enrollment, immediately after the intervention, and at 6 months follow-up
Secondary outcomes (11)
Life-Satisfaction Questionnaire -11 (LISAT-11)
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
Measured: Study enrollment, immediately after the intervention, and at 6 months follow-up
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
a 20-item self-report inventory used to assess severity of posttraumatic stress symptoms and monitoring symptom change during and after treatment
Measured: Study enrollment, immediately after the intervention, and at 6 months follow-up
Patient Health Questionnaire (PHQ-8)
an eight item, self-report inventory used to screen for the presence and severity of depression
Measured: Study enrollment, immediately after the intervention, and at 6 months follow-up
Generalized Anxiety Disorder Scale (GAD-7)
a seven item, self-report inventory used to screen for the presence and severity of anxiety
Measured: Study enrollment, immediately after the intervention, and at 6 months follow-up
Repeatable Battery for the Assessment of Neuropsychological Status Update (RBANS Update)
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
Measured: Study enrollment and immediately after the intervention
Sensory Organization Test (SOT)
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.
Measured: Study enrollment and immediately after the intervention
Behavior Rating Inventory of Executive Functioning - Adult Version (BRIEF-A)
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
Measured: Study enrollment and immediately after the intervention
Alcohol Use Disorders Identification Test- Concise (AUDIT-C)
a three-item, self-report screening tool used to identify people who with active alcohol use disorders (including alcohol abuse or dependence).
Measured: Study enrollment and at 6 months follow-up
Drug Abuse Screening Test (DAST-10)
a 10-item self-report instrument that yields a quantitative index of the degree of consequences related to drug use
Measured: Study enrollment and at 6 months follow-up
Cannabis Use Disorder Identification Test (CUDIT-R)
an 8-item measure designed for screening for problematic cannabis use and use a brief repeated outcome measure
Measured: Study enrollment and at 6 months follow-up
National Survey on Drug Use and Health (NSDUH)- 30-day use: Alcohol and Substances
survey of alcohol use (tallying days used and estimating average number of drinks per drinking day) and additional substances used (number of days used)
Measured: Study enrollment, immediately after the intervention, and at 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study startFeb 2025 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Concussion, Mild Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shepherd Center, Atlanta GA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06620900
- Sponsor's protocol ID
- 2156344
- Other IDs
- TP230246
- Acronym
- ExpandAccess
- Status last verified
- Sep 2024
- First submitted
- 23 Sep 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
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.
PubMed 36523344
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanding Access to mTBI Treatment for Veterans and Service Members With Co-occurring Substance Use
- ClinicalTrials.gov ID
- NCT06620900
- Acronym / sponsor ID
- ExpandAccess / 2156344
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Shepherd Center, Atlanta GAUniversity, hospital or other
- Study start
- Feb 2025 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Integrated Model of Care | Experimental | Other: Integrated Model of CareParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- History of brain injury other than mTBI or progressive neurological disorder
- Active psychosis
- Not able to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated Model of CareThe 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. | Other | Integrated Model of Care |
Primary outcome
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
11 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Background: PubMed 36523344Wallace 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Model of Care in people with Concussion, Mild Traumatic Brain Injury and Brain Injury, run by Shepherd Center, Atlanta GA at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Russell K Gore, MD (404-603-4980, russell.gore@shepherd.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurobehavioral Symptom Inventory (NSI) (time frame: Study enrollment, immediately after the intervention, and at 6 months follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06620900, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.