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| ID | Type | Description | Link |
|---|---|---|---|
| TP230246 | Other Grant/Funding Number | Department of Defense |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Study enrollment, immediately after the intervention, and at 6 months follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Russell K Gore, MD | Contact | 404-603-4980 | russell.gore@shepherd.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shepherd Center | Atlanta | Georgia | 30309 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36523344 | Background | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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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:
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We will complete upload of IPD by Aug 31, 2025.
Researchers can then file an application with FITBIR, following FITBIR processes and protocols, to request access to the data for research purposes.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | May 22, 2024 | Sep 23, 2024 |
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| 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 | 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 | 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 | 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 | 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. | 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 | 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). | 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 | 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 | 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) | Study enrollment, immediately after the intervention, and at 6 months follow-up |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| D001930 | Brain Injuries |
| D000070642 | Brain Injuries, Traumatic |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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