Not Yet RecruitingPhase 1

ENGAGE-TBI Feasibility Study

United States30 participantsStarted 2026-07

Plain-language summary

This study will first evaluate the feasibility of delivering the ENGAGE-TBI intervention in a community setting with adults with TBI.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

Client Satisfaction Questionnaire-8

Timeframe: Post-Treatment (6-weeks)

Pittsburgh Rehabilitation Participation Scale

Timeframe: 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

Timeframe: Baseline, Post-Treatment (6-weeks)

Trial details

NCT IDNCT07549997

SponsorWashington University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12

Contact for this trial

Jessica Kersey, PhD, OTR/L Assistant Professor, PhD, OTR/L

+1 314 273 7540 jkersey@wustl.edu

View on ClinicalTrials.gov More TBI (Traumatic Brain Injury) trials