Traumatic Brain Injury and Co-occurring DisordersVICTORY-RCTNCT07463027
Veteran's Interdisciplinary Care for Traumatic Brain Injury and Co-Occurring Disorders Rehabilitation Trial
A study testing 3-week interdisciplinary outpatient rehab program (IORP) in people with Traumatic Brain Injury and Co-occurring Disorders, run by Medical College of Wisconsin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Traumatic Brain Injury and Co-occurring Disorders
- What is being tested?
- 3-week interdisciplinary outpatient rehab program (IORP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 416 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2026to May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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?
Read more
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*
- Being tested
- 3-week interdisciplinary outpatient rehab program (IORP)
- Keywords
- Traumatic Brain Injury, Veterans, First Responders, TBI, Interdisciplinary Outpatient Rehabilitation Program, IORP
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-week interdisciplinary outpatient rehab program (IORP)Behavioural
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 group | Role | What they receive |
|---|---|---|
| Interdisciplinary Outpatient Rehabilitation Program Intervention Arm | Other | Participants in this arm will start the 3-Week TBI IORP after baseline evaluation and receiving the recommendation to participate in the IORP. Receives: Behavioral: 3-week interdisciplinary outpatient rehab program (IORP) |
| Control Waiting Period Arm | Other | 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. Receives: Behavioral: 3-week interdisciplinary outpatient rehab program (IORP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in Neurobehavioral Symptom Inventory (NSI)
The NSI is a 22-item self-report questionnaire used to assess neurobehavioral symptoms, particularly those following a TBI
Measured: Baseline enrollment to 3-month follow-up (post IORP)
Secondary outcomes (3)
Mean change in Satisfaction with Life Scale (SWLS)
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)
Measured: Baseline enrollment to 3 months post-IORP and 6 months post-IORP
Life Satisfaction Questionnaire (LISAT-11)
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.
Measured: Baseline enrollment to 3 months post-IORP and 6 months post-IORP
Participation Assessment with Recombined Tools-Objective (PART-O)
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.
Measured: Baseline enrollment to 3 months post-IORP and 6 months post-IORP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start26 Mar 2026
- Primary completionFeb 2029 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain Injury and Co-occurring DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 416 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Diego, University of North Carolina, Chapel Hill, University of Florida, Moss Rehabilitation Research Institute, University of Colorado, Denver
- Responsible party
- Principal investigator, Michael McCrea, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07463027
- Sponsor's protocol ID
- PRO00056712
- Acronym
- VICTORY-RCT
- Status last verified
- Mar 2026
- First submitted
- 27 Feb 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Veteran's Interdisciplinary Care for Traumatic Brain Injury & Co-Occurring Disorders Rehabilitation Trial - A Pragmatic, Randomized, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07463027
- Acronym / sponsor ID
- VICTORY-RCT / PRO00056712
- Keywords
- Traumatic Brain Injury, Veterans, First Responders, TBI, Interdisciplinary Outpatient Rehabilitation Program, IORP
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 416 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- University of California, San Diego, University of North Carolina, Chapel Hill, University of Florida, Moss Rehabilitation Research Institute, University of Colorado, Denver
- Study start
- 26 Mar 2026 (actual)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interdisciplinary Outpatient Rehabilitation Program Intervention Arm | Other | Behavioral: 3-week interdisciplinary outpatient rehab program (IORP)Participants in this arm will start the 3-Week TBI IORP after baseline evaluation and receiving the recommendation to participate in the IORP. |
| Control Waiting Period Arm | Other | Behavioral: 3-week interdisciplinary outpatient rehab program (IORP)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Behavioural | Control Waiting Period Arm, Interdisciplinary Outpatient Rehabilitation Program Intervention Arm |
Primary outcome
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
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3-week interdisciplinary outpatient rehab program (IORP) in people with Traumatic Brain Injury and Co-occurring Disorders, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in Neurobehavioral Symptom Inventory (NSI) (time frame: Baseline enrollment to 3-month follow-up (post IORP)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.