Veteran's Interdisciplinary Care for Traumatic Brain Injury and Co-Occurring Disorders Rehabilitation Trial

Part of paid clinical trials in Milwaukee, Wisconsin.

Sponsor
Medical College of Wisconsin
Study ID
NCT07463027
Status
Enrolling By Invitation

Conditions

  • Traumatic Brain Injury and Co-occurring Disorders

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • 3-week interdisciplinary outpatient rehab program (IORP) — BEHAVIORAL
    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).

Study Details

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\*

Key Dates

Start date
Mar 26, 2026
Status verified
Mar 2026
Primary completion
Feb 28, 2029
Completion
May 31, 2029

Study Design

Enrollment
416 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Interdisciplinary Outpatient Rehabilitation Program Intervention Arm
    Participants in this arm will start the 3-Week TBI IORP after baseline evaluation and receiving the recommendation to participate in the IORP.
  • Other: Control Waiting Period Arm
    Participants in this arm will start the 3-Week TBI IORP after observing at least a 3 month waiting period after baseline evaluation and receiving the recommendation to participate in the IORP.

Primary Outcome Measure

Mean change in Neurobehavioral Symptom Inventory (NSI) [ Time Frame: Baseline enrollment to 3-month follow-up (post IORP) ]

Locations (1)

FacilityCityStateZIPSite coordinators
BRAVE ProgramMilwaukeeWisconsin53226-

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