Clinical trial Recruiting at 1 site Phase 1 Interventional Ages 18 and up

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

PhasePhase 1
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment30 (estimated)
SponsorWashington University School of Medicine
Academic / other
Locations1 site (St Louis, Missouri)
StatusRecruiting
StartedAugust 17, 2026
Main results expectedDecember 2027
Study endsApril 2028
Registry record updatedAugust 18, 2026
Trial IDNCT07549997 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

  • Washington University School of Medicine
    St Louis, Missouri, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.