ENGAGE-TBI Feasibility Study

August 17, 2026 updated by: Jessica Kersey, Washington University School of Medicine
This study will first evaluate the feasibility of delivering the ENGAGE-TBI intervention in a community setting with adults with TBI.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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
        • Recruiting
        • 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:
        • Principal Investigator:
          • Jessica Kersey, PhD, OTR/L, PhD, OTR/L

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Client Satisfaction Questionnaire-8
Time Frame: Post-Treatment (6-weeks)
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
Time Frame: Immediately 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.
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)
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
PROMIS (Patient-Reported Outcome Measures Information System) Social Isolation
Time Frame: Baseline, Post-Treatment (6-weeks)
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)
Time Frame: Baseline, Post-Treatment (6-weeks)
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Washington University School of Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
American Occupational Therapy Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 17, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 6, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 24, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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