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

March 27, 2026 updated by: Michael McCrea, Medical College of Wisconsin

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

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

416

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • BRAVE Program

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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).
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.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline enrollment to 3-month follow-up (post IORP)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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
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.
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
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.
Baseline enrollment to 3 months post-IORP and 6 months post-IORP

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical College of Wisconsin

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 26, 2026

Primary Completion (Estimated)

February 1, 2029

Study Completion (Estimated)

May 1, 2029

Study Registration Dates

First Submitted

February 27, 2026

First Submitted That Met QC Criteria

March 6, 2026

First Posted (Actual)

March 10, 2026

Study Record Updates

Last Update Posted (Actual)

April 2, 2026

Last Update Submitted That Met QC Criteria

March 27, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO00056712

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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