ENGAGE-TBI: A Feasibility Program to Reduce Social Isolation for Adults with Traumatic Brain Injury
Official title: ENGAGE-TBI Feasibility Study
Run by Washington University School of Medicine · NCT07549997 · Data updated 2026-11-12
We’re testing a 12-session group program to help adults with traumatic brain injury in the community build social participation and reduce isolation.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Washington University School of Medicine Academic / other |
| Locations | 1 site (St Louis, Missouri) |
| Status | Recruiting |
| Started | August 17, 2026 |
| Main results expected | December 2027 |
| Study ends | April 2028 |
| Registry record updated | August 18, 2026 |
| Trial ID | NCT07549997 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years or older with a brain injury for more than 6 months, residing in the St. Louis area, who report reduced social participation and can participate in group sessions.
✕Probably not a fit
Individuals with severe cognitive impairment or active substance use disorder may not experience benefit from this group intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 1 feasibility study that will enroll 30 adults with traumatic brain injury living in the St. Louis area to try the ENGAGE-TBI intervention. The program blends social learning, guided problem-solving, and real-world practice over six weeks, co-facilitated by an occupational therapist and a peer mentor with TBI. Outcomes will focus on feasibility metrics such as fidelity, engagement, attendance, retention, and satisfaction, with preliminary changes in social participation measured by PROMIS. A single-group pre-post design will estimate effect sizes to inform future studies. Findings will help determine whether broader testing of ENGAGE-TBI is warranted in community settings.
Why it matters
Potential benefit: If successful, participants might experience greater social participation and reduced isolation through a structured community-based program.
How similar studies have gone: Previous work on community-based, peer-supported occupational therapy approaches for social participation has shown potential, but this specific ENGAGE-TBI feasibility trial is an initial, exploratory step.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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)
Where it's running
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Washington University School of Medicine
St Louis, Missouri, United States Recruiting
Study contacts
- Study coordinator: Jessica Kersey, PhD, OTR/L Assistant Professor, PhD, OTR/L
- Email: jkersey@wustl.edu
- Phone: +1 314 273 7540
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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ReVIVE for mTBI: Using VR and therapy to help adults with mild traumatic brain injury
This study tests a virtual reality therapy combined with standard psychotherapy to see if it can reduce PTSD symptoms and improve executive function in adults with mild traumatic brain injury.
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Fibrinogen-to-Albumin Ratio as a Predictor of ARDS in Traumatic Brain Injury
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A small pilot test will see if a partnered person with TBI and a close supporter can successfully participate in a 12-week program to improve social support and daily life participation.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.