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Enrolling by Invitation

NCT Number: NCT07463027

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

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*

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Key information

Conditions

Traumatic Brain Injury and Co-occurring Disorders Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BRAVE Program

Milwaukee, Wisconsin, 53226, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. Mean change in Neurobehavioral Symptom Inventory (NSI)

    Time frame: 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 outcomes

  1. Mean change in Satisfaction with Life Scale (SWLS)

    Time frame: 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)

  2. Life Satisfaction Questionnaire (LISAT-11)

    Time frame: 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.

  3. Participation Assessment with Recombined Tools-Objective (PART-O)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Collaborators

  • Moss Rehabilitation Research Institute
  • University of California, San Diego
  • University of Colorado Denver - Anschutz Medical Campus (UCD-AMC)
  • University of Florida
  • University of North Carolina, Chapel Hill

Registry information

Official study title

Veteran's Interdisciplinary Care for Traumatic Brain Injury & Co-Occurring Disorders Rehabilitation Trial - A Pragmatic, Randomized, Controlled Clinical Trial

Acronym: VICTORY-RCT

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Mar 10, 2026
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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