NCT07549997 · Washington University School of Medicine
ENGAGE-TBI Feasibility Study
What this study is about
This study will first evaluate the feasibility of delivering the ENGAGE-TBI intervention in a community setting with adults with TBI.
View original scientific description
This study will first evaluate the feasibility of delivering the ENGAGE-TBI intervention in a community setting with adults with TBI.
Interventions
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.
Primary outcome measures
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
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.
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)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)
Where
- St Louis, Missouri
Collaborators
American Occupational Therapy Foundation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 18, 2026 · Source of record for eligibility and locations