Recruiting
Phase 1

ENGAGE-TBI

Sponsor:

Washington University School of Medicine

Code:

NCT07549997

Conditions

TBI (Traumatic Brain Injury)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Social intervention study for TBI survivors

Study Details

Brief summary:

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

Conditions

TBI (Traumatic Brain Injury)

Study ID

NCT07549997

Start date

Aug 17, 2026

Status verified date

Apr, 2026

Completion date

Apr, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ENGAGE-TBI

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.

Interventions

Social intervention study for TBI survivors

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.

Primary outcome measure

  • Client Satisfaction Questionnaire-8 [ Time Frame: Post-Treatment (6-weeks) ]
  • Pittsburgh Rehabilitation Participation Scale [ Time Frame: 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 [ Time Frame: Baseline, Post-Treatment (6-weeks) ]

Central Contacts and Locations

Central contacts

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

+1 314 273 7540jkersey@wustl.edu

Curtis Comer, Clinical Research Coordinator I, High School

+1 314 273 3288curtisccomer@wustl.edu

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

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

+1 314 273 7540jkersey@wustl.edu

Curtis Comer, Clinical Research Coordinator I, High School

curtisccomer@wustl.edu

Principal Investigator:

Jessica Kersey, PhD, OTR/L, PhD, OTR/L

More Information

Sponsor

Washington University School of Medicine

Last update posted

Aug 18, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-08-18.