ENGAGE-TBI Feasibility Study

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

Study Overview

• Status: Not yet recruiting
• Conditions: TBI (Traumatic Brain Injury)
• Intervention / Treatment: Behavioral: Social intervention study for TBI survivors

Detailed Description

Social isolation is a prevalent and highly prioritized concern among people with traumatic brain injury (TBI), contributing to poor physical and mental health outcomes. Existing rehabilitation interventions have focused primarily on remediating underlying impairments, with limited success in improving social participation. A patient-directed, self-management approach may offer a promising alternative. This study aims to evaluate the feasibility of ENGAGE-TBI, a novel, theory-driven occupational therapy intervention designed to reduce social isolation by increasing social participation among community-dwelling adults with TBI. Using a single-group pre-post design, this study will enroll 30 adults with TBI recruited through the Brain Injury Association of Missouri. ENGAGE-TBI is a 12-session group intervention co-facilitated by an occupational therapist and a peer mentor with TBI. The intervention integrates three core elements - social learning, guided problem-solving, and skilled community practice - delivered across six weeks. Feasibility outcomes include fidelity, participant engagement, satisfaction, attendance, and retention. The primary clinical outcome is social participation, measured using the PROMIS Ability to Participate in Social Roles and Activities. Feasibility outcomes will be examined descriptively against pre-specified benchmarks. Within-group Cohen's d effect sizes with 95% confidence intervals will be calculated to estimate intervention effects and variability, informing the design of a future randomized controlled trial. Findings will support the development of a fully-powered effectiveness trial. This study addresses a critical gap in TBI rehabilitation by testing a stakeholder-informed, community-based intervention that treats TBI as a chronic condition and prioritizes patient-directed goal achievement over impairment remediation.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Jessica Kersey, PhD, OTR/L Assistant Professor, PhD, OTR/L; Phone Number: +1 314 273 7540; Email: jkersey@wustl.edu
• Study Contact Backup: Name: Curtis Comer, Clinical Research Coordinator I, High School; Phone Number: +1 314 273 3288; Email: curtisccomer@wustl.edu

Study Locations

• United States
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Washington University School of Medicine
      • Contact: Jessica Kersey, PhD, OTR/L Assistant Professor, PhD, OTR/L; Phone Number: +1 314 273 7540; Email: jkersey@wustl.edu
      • Contact: Curtis Comer, Clinical Research Coordinator I, High School; Email: curtisccomer@wustl.edu
      • Principal Investigator: Jessica Kersey, PhD, OTR/L, PhD, OTR/L

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Client Satisfaction Questionnaire-8	8-item measure of intervention satisfaction with a 4-point Likert scale (8-32); higher scores indicate greater satisfaction	Post-Treatment (6-weeks)
Pittsburgh Rehabilitation Participation Scale	Interventionist-administered measure of engagement in each intervention session; reported on a 1-6 scale, with higher scores indicating greater participation.	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	Computer adaptive test examining social participation abilities; scores reported as T-scores (0-100 scale, with higher scores indicating greater participation)	Baseline, Post-Treatment (6-weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROMIS (Patient-Reported Outcome Measures Information System) Social Isolation	Computer Adaptive Test examining social isolation; scores reported as T-scores (0-100 scale, higher scores indicate higher isolation)	Baseline, Post-Treatment (6-weeks)
PROMIS-29 (Patient-Reported Outcome Measures Information System)	29-item measure of multiple health domains using a 5-point Likert scale and reported as T-scores (0-100 scale, lower scores indicate greater health)	Baseline, Post-Treatment (6-weeks)

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: American Occupational Therapy Foundation

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: April 6, 2026
• First Submitted That Met QC Criteria: April 17, 2026
• First Posted (Actual): April 24, 2026

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: 202503070

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: This study will produce feasibility data and clinical outcome data on 30 participants with brain injury. De-identified data will be shared for all patient-reported outcome measures: Client Satisfaction Questionnaire-8, PROMIS Ability to Participate in Social Roles and Activities, PROMIS Social Isolation, and PROMIS-29. Raw data will be transformed to T-scores on the PROMIS measures, and T-scores will be used on the shared dataset.
• IPD Sharing Time Frame: Data will be made available six months after the end of the grant period and will be made available for a minimum of 10 years.
• IPD Sharing Access Criteria: The dataset and data dictionary will be disseminated via the Washington University Research Data Repository, which is publicly available. Controlled access will not be used. The data that are shared will be shared by unrestricted download.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No