TBI (Traumatic Brain Injury)Phase 1NCT07549997
ENGAGE-TBI Feasibility Study
A Phase 1 study testing Social intervention study for TBI survivors in people with TBI (Traumatic Brain Injury), run by Washington University School of Medicine at 1 site in United States.
Trial summary
This study will first evaluate the feasibility of delivering the ENGAGE-TBI intervention in a community setting with adults with TBI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- TBI (Traumatic Brain Injury)
- What is being tested?
- Social intervention study for TBI survivors
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2026to Apr 2028
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least 18 years old
- experienced a TBI > 6 months prior to enrollment, confirmed by a physician as documented in their medical record
- live in the St. Louis area
- report problems with social participation (retention of < 80% of pre-TBI social activities as measured by Activity Card Sort)
Who cannot join
- insufficient English language fluency to participate in the group intervention
- have active substance use disorder (PRIME-MD MINI)
- have an untreated psychotic disorder (PRIME-MD MINI)
- have severe memory impairment that would limit their ability to recall strategies with support (Montreal Cognitive Assessment, < 21)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Curtis Comer, Clinical Research Coordinator I, High School contact
United States1 site, 1 recruiting
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Jessica Kersey, PhD, OTR/L Assistant Professor, PhD, OTR/L, +1 314 273 7540, jkersey@wustl.edu
Curtis Comer, Clinical Research Coordinator I, High School, curtisccomer@wustl.edu
About this study
This study will first evaluate the feasibility of delivering the ENGAGE-TBI intervention in a community setting with adults with TBI.
Read the detailed description
Social isolation is a prevalent and highly prioritized concern among people with traumatic brain injury (TBI), contributing to poor physical and mental health outcomes. Existing rehabilitation interventions have focused primarily on remediating underlying impairments, with limited success in improving social participation. A patient-directed, self-management approach may offer a promising alternative. This study aims to evaluate the feasibility of ENGAGE-TBI, a novel, theory-driven occupational therapy intervention designed to reduce social isolation by increasing social participation among community-dwelling adults with TBI. Using a single-group pre-post design, this study will enroll 30 adults with TBI recruited through the Brain Injury Association of Missouri. ENGAGE-TBI is a 12-session group intervention co-facilitated by an occupational therapist and a peer mentor with TBI. The intervention integrates three core elements - social learning, guided problem-solving, and skilled community practice - delivered across six weeks. Feasibility outcomes include fidelity, participant engagement, satisfaction, attendance, and retention. The primary clinical outcome is social participation, measured using the PROMIS Ability to Participate in Social Roles and Activities. Feasibility outcomes will be examined descriptively against pre-specified benchmarks. Within-group Cohen's d effect sizes with 95% confidence intervals will be calculated to estimate intervention effects and variability, informing the design of a future randomized controlled trial. Findings will support the development of a fully-powered effectiveness trial. This study addresses a critical gap in TBI rehabilitation by testing a stakeholder-informed, community-based intervention that treats TBI as a chronic condition and prioritizes patient-directed goal achievement over impairment remediation.
- Conditions
- TBI (Traumatic Brain Injury)
- Being tested
- Social intervention study for TBI survivors
- 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.
Social intervention study for TBI survivorsBehavioural
ENGAGE-TBI is a community-based group intervention that is co-facilitated by an occupational therapist and a person with a brain injury. ENGAGE-TBI incorporates social learning, guided problem-solving, and skilled practice of strategies to achieve social participation goals. It is delivered in 12 90-minute group sessions that are held twice per week for 6 weeks. Aside from community outings, sessions will take place at the Brain Injury Association of Missouri on a separate day and time from education group sessions.
| Study group | Role | What they receive |
|---|---|---|
| ENGAGE-TBI | Experimental | The outcome measures for feasibility will be participant satisfaction (Client Satisfaction Questionnaire-8), intervention fidelity, engagement in intervention (Pittsburgh Rehabilitation Participation Scale), attendance rate, and retention rate. Receives: Behavioral: Social intervention study for TBI survivors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Client Satisfaction Questionnaire-8
8-item measure of intervention satisfaction with a 4-point Likert scale (8-32); higher scores indicate greater satisfaction
Measured: Post-Treatment (6-weeks)
Pittsburgh Rehabilitation Participation Scale
Interventionist-administered measure of engagement in each intervention session; reported on a 1-6 scale, with higher scores indicating greater participation.
Measured: Immediately at the conclusion of each intervention session (included as part of the interventionist's session documentation)
PROMIS (Patient-Reported Outcome Measures Information System) Ability to Participate in Social Roles and Activities
Computer adaptive test examining social participation abilities; scores reported as T-scores (0-100 scale, with higher scores indicating greater participation)
Measured: Baseline, Post-Treatment (6-weeks)
Secondary outcomes (2)
PROMIS (Patient-Reported Outcome Measures Information System) Social Isolation
Computer Adaptive Test examining social isolation; scores reported as T-scores (0-100 scale, higher scores indicate higher isolation)
Measured: Baseline, Post-Treatment (6-weeks)
PROMIS-29 (Patient-Reported Outcome Measures Information System)
29-item measure of multiple health domains using a 5-point Likert scale and reported as T-scores (0-100 scale, lower scores indicate greater health)
Measured: Baseline, Post-Treatment (6-weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start17 Aug 2026
- Primary completionDec 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TBI (Traumatic Brain Injury)Studies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- American Occupational Therapy Foundation
- Responsible party
- Principal investigator, Jessica Kersey, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07549997
- Sponsor's protocol ID
- 202503070
- Status last verified
- Apr 2026
- First submitted
- 6 Apr 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This study will produce feasibility data and clinical outcome data on 30 participants with brain injury. De-identified data will be shared for all patient-reported outcome measures: Client Satisfaction Questionnaire-8, PROMIS Ability to Participate in Social Roles and Activities, PROMIS Social Isolation, and PROMIS-29. Raw data will be transformed to T-scores on the PROMIS measures, and T-scores will be used on the shared dataset.
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ENGAGE-TBI Feasibility Study
- ClinicalTrials.gov ID
- NCT07549997
- Acronym / sponsor ID
- 202503070
- Conditions
- TBI (Traumatic Brain Injury)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- American Occupational Therapy Foundation
- Study start
- 17 Aug 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 24 Apr 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.
This study will first evaluate the feasibility of delivering the ENGAGE-TBI intervention in a community setting with adults with TBI.
Detailed description
Social isolation is a prevalent and highly prioritized concern among people with traumatic brain injury (TBI), contributing to poor physical and mental health outcomes. Existing rehabilitation interventions have focused primarily on remediating underlying impairments, with limited success in improving social participation. A patient-directed, self-management approach may offer a promising alternative. This study aims to evaluate the feasibility of ENGAGE-TBI, a novel, theory-driven occupational therapy intervention designed to reduce social isolation by increasing social participation among community-dwelling adults with TBI. Using a single-group pre-post design, this study will enroll 30 adults with TBI recruited through the Brain Injury Association of Missouri. ENGAGE-TBI is a 12-session group intervention co-facilitated by an occupational therapist and a peer mentor with TBI. The intervention integrates three core elements - social learning, guided problem-solving, and skilled community practice - delivered across six weeks. Feasibility outcomes include fidelity, participant engagement, satisfaction, attendance, and retention. The primary clinical outcome is social participation, measured using the PROMIS Ability to Participate in Social Roles and Activities. Feasibility outcomes will be examined descriptively against pre-specified benchmarks. Within-group Cohen's d effect sizes with 95% confidence intervals will be calculated to estimate intervention effects and variability, informing the design of a future randomized controlled trial. Findings will support the development of a fully-powered effectiveness trial. This study addresses a critical gap in TBI rehabilitation by testing a stakeholder-informed, community-based intervention that treats TBI as a chronic condition and prioritizes patient-directed goal achievement over impairment remediation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ENGAGE-TBI | Experimental | Behavioral: Social intervention study for TBI survivorsThe outcome measures for feasibility will be participant satisfaction (Client Satisfaction Questionnaire-8), intervention fidelity, engagement in intervention (Pittsburgh Rehabilitation Participation Scale), attendance rate, and retention rate. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- at least 18 years old
- experienced a TBI > 6 months prior to enrollment, confirmed by a physician as documented in their medical record
- live in the St. Louis area
- report problems with social participation (retention of < 80% of pre-TBI social activities as measured by Activity Card Sort)
Key exclusion criteria (4 listed)
- insufficient English language fluency to participate in the group intervention
- have active substance use disorder (PRIME-MD MINI)
- have an untreated psychotic disorder (PRIME-MD MINI)
- have severe memory impairment that would limit their ability to recall strategies with support (Montreal Cognitive Assessment, < 21)
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 |
|---|---|---|
| Social intervention study for TBI survivorsENGAGE-TBI is a community-based group intervention that is co-facilitated by an occupational therapist and a person with a brain injury. ENGAGE-TBI incorporates social learning, guided problem-solving, and skilled practice of strategies to achieve social participation goals. It is delivered in 12 90-minute group sessions that are held twice per week for 6 weeks. Aside from community outings, sessions will take place at the Brain Injury Association of Missouri on a separate day and time from education group sessions. | Behavioural | ENGAGE-TBI |
Primary outcome
Client Satisfaction Questionnaire-8
Time frame: Post-Treatment (6-weeks)
8-item measure of intervention satisfaction with a 4-point Likert scale (8-32); higher scores indicate greater satisfaction
Pittsburgh Rehabilitation Participation Scale
Time frame: Immediately at the conclusion of each intervention session (included as part of the interventionist's session documentation)
Interventionist-administered measure of engagement in each intervention session; reported on a 1-6 scale, with higher scores indicating greater participation.
PROMIS (Patient-Reported Outcome Measures Information System) Ability to Participate in Social Roles and Activities
Time frame: Baseline, Post-Treatment (6-weeks)
Computer adaptive test examining social participation abilities; scores reported as T-scores (0-100 scale, with higher scores indicating greater participation)
2 secondary outcomes
PROMIS (Patient-Reported Outcome Measures Information System) Social Isolation
Time frame: Baseline, Post-Treatment (6-weeks)
PROMIS-29 (Patient-Reported Outcome Measures Information System)
Time frame: Baseline, Post-Treatment (6-weeks)
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 18 Aug 2026.
- Individual participant dataSharing planned: Yes. This study will produce feasibility data and clinical outcome data on 30 participants with brain injury. De-identified data will be shared for all patient-reported outcome measures: Client Satisfaction Questionnaire-8, PROMIS Ability to Participate in Social Roles and Activities, PROMIS Social Isolation, and PROMIS-29. Raw data will be transformed to T-scores on the PROMIS measures, and T-scores will be used on the shared dataset.
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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.
Curtis Comer, Clinical Research Coordinator I, High School contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Social intervention study for TBI survivors in people with TBI (Traumatic Brain Injury), run by Washington University School of Medicine 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 4 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: looking for participants now, as of the sponsor's last update on 18 Aug 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Jessica Kersey, PhD, OTR/L Assistant Professor, PhD, OTR/L (+1 314 273 7540, jkersey@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Client Satisfaction Questionnaire-8 (time frame: Post-Treatment (6-weeks)). The study lists 3 primary outcomes in all. 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 18 Aug 2026.