Veteran's Interdisciplinary Care for Traumatic Brain Injury and Co-Occurring Disorders Rehabilitation Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 3-week interdisciplinary outpatient rehab program (IORP).
- Who it may be relevant to
- Registry conditions: Traumatic Brain Injury and Co-occurring Disorders. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Veteran's Interdisciplinary Care for Traumatic Brain Injury & Co-Occurring Disorders Rehabilitation Trial - A Pragmatic, Randomized, Controlled Clinical Trial
Overview
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
- Behavioral 3-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).
Primary outcome measures
- Mean change in Neurobehavioral Symptom Inventory (NSI) [Time frame: Baseline enrollment to 3-month follow-up (post IORP)]
Secondary outcome measures (3)
- Mean change in Satisfaction with Life Scale (SWLS) [Time frame: Baseline enrollment to 3 months post-IORP and 6 months post-IORP]
- Life Satisfaction Questionnaire (LISAT-11) [Time frame: Baseline enrollment to 3 months post-IORP and 6 months post-IORP]
- Participation Assessment with Recombined Tools-Objective (PART-O) [Time frame: Baseline enrollment to 3 months post-IORP and 6 months post-IORP]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- BRAVE Program — Milwaukee
Identifiers
NCT: NCT07463027 · PRO00056712