ENGAGE-TBI Feasibility Study

{ "ENGAGE-TBI Feasibility Study for Traumatic Brain Injury", "This study, called ENGAGE-TBI, is testing a new group program designed to help adults who have had a traumatic brain injury (TBI) improve their social lives. The program is led by an occupational therapist and someone who also has a brain injury. It focuses on learning social skills, solving problems, and practicing strategies in the community over 12 sessions across six weeks. You might be able to join if you are at least 18, had a TBI more than six months ago, live in the St. Louis area, and have trouble with social activities. The study aims to see how practical and satisfying the ENGAGE-TBI program is, and if it helps people participate more in social roles and activities. The study plans to enroll 30 participants.", "design": "This is a single-group study, meaning all 30 participants will receive the ENGAGE-TBI intervention. It is designed to evaluate the feasibility of the intervention.", "commitments": "You would participate in a 12-session group intervention over six weeks. Your satisfaction and participation will be measured at the end of the program.", "compensation": "Not stated in the trial record.", "follow_up": "Your satisfaction and ability to participate in social roles and activities will be measured at the end of the 6-week treatment period.", }

Study design
Not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07549997

ENGAGE-TBI Feasibility Study

Recruiting
PHASE1Ages 18+InterventionalTreatment
Washington University School of Medicine
~30 participants
Updated 2026-08-18 on ClinicalTrials.gov
What's tested:Social intervention study for TBI survivors

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Client Satisfaction Questionnaire-8
Measured over Post-Treatment (6-weeks)
+2 more outcomes measured
TBI (Traumatic Brain Injury)
1 sites across 1 states
Missouri1
Jessica Kersey, PhD, OTR/L Assistant Professor, PhD, OTR/L
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Eligibility criteria

Inclusion

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

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)
  • Client Satisfaction Questionnaire-8Post-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 ScaleImmediately 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 ActivitiesBaseline, 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)