30 Participants NeededMy employer runs this trial

Social Intervention for TBI

JK
CC
Overseen ByCurtis Comer, Clinical Research Coordinator I, High School
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Washington University School of Medicine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new social intervention called ENGAGE-TBI to determine its feasibility and effectiveness for individuals with traumatic brain injury (TBI). The intervention aims to help adults with TBI enhance their social lives by engaging in community settings. It targets those in the St. Louis area who experienced a TBI over six months ago and struggle to maintain social activities they once enjoyed. Individuals who have retained less than 80% of their pre-TBI social activities may be suitable candidates. The trial will assess participant satisfaction, adherence to the program, and level of engagement. As a Phase 1 trial, the research focuses on understanding how the treatment functions in people, offering participants the chance to be among the first to benefit from this innovative approach.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the ENGAGE-TBI intervention is safe for adults with TBI?

Research shows that most people find the ENGAGE-TBI treatment easy to handle. In a previous study, 80% of participants reported high satisfaction, and all engaged actively. This indicates that participants generally liked the treatment and were eager to take part. While this doesn't directly address safety, it suggests that any side effects were likely minor or manageable. As this trial is in the early stages, the researchers are primarily observing participants' reactions to the treatment rather than focusing on detailed safety results.12345

Why are researchers excited about this trial?

ENGAGE-TBI is unique because it focuses on a social intervention approach to treat traumatic brain injury (TBI), unlike traditional methods that often rely on medication or physical rehabilitation alone. Researchers are excited about this treatment because it emphasizes participant engagement and satisfaction, which could lead to improved outcomes by fostering a stronger patient-provider connection. This approach could enhance rehabilitation participation and retention rates, potentially transforming the way TBI recovery is supported.

What evidence suggests that the ENGAGE-TBI intervention is effective for TBI?

Research has shown that the ENGAGE-TBI program, which trial participants will receive, has yielded promising results in early studies. Participants expressed high satisfaction, with 80% providing positive feedback. All participants fully engaged with the program, suggesting its potential effectiveness. Other studies on TBI rehabilitation have demonstrated improvements in social and daily activities for participants. Although ENGAGE-TBI remains new, these early findings suggest it might enhance social participation for individuals with traumatic brain injury (TBI).12567

Are You a Good Fit for This Trial?

This trial is for adults (18+) living in the St. Louis area who had a traumatic brain injury over 6 months ago, have trouble with social activities since their injury, and can participate in group sessions. People with active substance use issues, untreated psychosis, severe memory problems, or limited English can't join.

Inclusion Criteria

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)
See 1 more

Exclusion Criteria

Active substance use disorder (PRIME-MD MINI)
Untreated psychotic disorder (PRIME-MD MINI)
Insufficient English language fluency to participate in the group intervention
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the ENGAGE-TBI intervention, a 12-session group intervention over six weeks, focusing on social learning, guided problem-solving, and skilled community practice.

6 weeks
12 sessions (in-person)

Follow-up

Participants are monitored for social participation and satisfaction post-treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • ENGAGE-TBI

Trial Overview

The study is testing whether a new community-based social program called ENGAGE-TBI can be successfully delivered to adults recovering from traumatic brain injury. It focuses on helping participants improve their social participation.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: ENGAGE-TBIExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials
2,027
Recruited
2,353,000+

American Occupational Therapy Foundation

Collaborator

Trials
14
Recruited
380+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39773100/

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