Traumatic Brain Injury and Co-occurring Disorders
Conditions
Keywords
Traumatic Brain Injury, Veterans, First Responders, TBI, Interdisciplinary Outpatient Rehabilitation Program, IORP
Brief summary
The goal of this clinical trial is to learn if the Avalon Action Alliance Interdisciplinary Outpatient Rehabilitation Program (IORP) can reduce long-lasting symptoms of traumatic brain injury (TBI) and co-occurring disorders in veterans and first responders. The main questions it aims to answer are: * Does a 3-week IORP reduce symptoms of long-lasting TBI and co-occurring disorders in military veterans and first responders? * Does the 3-week IORP improve life quality and function in military veterans and first responders? Researchers will compare the Control group to the Invention group to see if a 3-week of IORP reduced symptoms of TBI and co-occurring disorders in military veterans and first responders. Participants will complete the following activities. The items with an asterisk(\*) are not required or available at all sites. * Answer online survey questions about their TBI symptoms, life satisfaction, and life activities * Complete two blood draws\* * Complete two magnetic resonance imaging (MRI) brain scans\*
Interventions
BEHAVIORAL3-week interdisciplinary outpatient rehab program (IORP)
Interdisciplinary outpatient rehabilitation program (IORP) for military veterans and first responders experiencing chronic effects of traumatic brain injury (TBI) and co-occurring disorders (e.g., posttraumatic stress disorder, depression, substance use).
Sponsors
Medical College of Wisconsin
University of California, San Diego
University of North Carolina, Chapel Hill
University of Florida
Moss Rehabilitation Research Institute
University of Colorado Denver - Anschutz Medical Campus (UCD-AMC)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Meets general eligibility requirements for site specific 3-week IORP * Capable of providing informed consent for IORP and study participation * English speaking * 18 to 65 years old
Exclusion criteria
* History of TBI of any severity in the past 6 months * Active substance use disorder that precludes study participation * Neurologic, psychiatric, or other medical condition that would prohibit full study participation * Active-duty military service member * Any other circumstance that, in the opinion of the investigator, would undermine the integrity or success of the project
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in Neurobehavioral Symptom Inventory (NSI) | Baseline enrollment to 3-month follow-up (post IORP) | The NSI is a 22-item self-report questionnaire used to assess neurobehavioral symptoms, particularly those following a TBI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in Satisfaction with Life Scale (SWLS) | Baseline enrollment to 3 months post-IORP and 6 months post-IORP | The SWLS is a brief questionnaire used to assess an individual's general satisfaction with their life. It is a self-report scale where participants respond to five statements using a 7-point Likert scale (1 = strongly disagree to 7 = strongly agree) |
| Life Satisfaction Questionnaire (LISAT-11) | Baseline enrollment to 3 months post-IORP and 6 months post-IORP | LISAT-11 is a brief questionnaire used to assess life satisfaction in life domains such as: vocational, financial and leisure situations, contact with friends, sexual life, self-care management, family life, partner relationship, physical health, and psychological health. |
| Participation Assessment with Recombined Tools-Objective (PART-O) | Baseline enrollment to 3 months post-IORP and 6 months post-IORP | The PART-O measures an individual's engagement in everyday life across 17 items spanning three domains: Productivity, Social Relations, and Out and About. The PART-O was developed to examine long-term outcomes and can also be used to evaluate the effectiveness of rehabilitative interventions to improve social/societal functioning. |
Countries
United States
Outcome results
None listed