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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
360
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.
Shepherd Center
Atlanta, Georgia, United States
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
Time frame: 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
Time frame: Study enrollment, immediately after the intervention, and at 6 months follow-up
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
Time frame: 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
Time frame: 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
Time frame: 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
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)
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
Time frame: 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.
Time frame: 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
Time frame: 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).
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: Study enrollment, immediately after the intervention, and at 6 months follow-up
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