Social Intervention for TBI
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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.
Follow-up
Participants are monitored for social participation and satisfaction post-treatment
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
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Washington University School of Medicine
Lead Sponsor
American Occupational Therapy Foundation
Collaborator
Citations
ENGAGE-TBI: adaptation of a community-based intervention ...
ENGAGE-TBI resulted in high satisfaction for 80% of participants and high engagement in intervention for 100% of participants. Attendance and ...
NCT07549997 | 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. ... Social ...
Participation as an Outcome of Traumatic Brain Injury ...
This study suggested that TBI rehabilitation improves an individual's functioning and meaningful participation in social and daily living activities and shows ...
Traumatic Brain Injury In the United States: Epidemiology ...
Effectiveness of Physical Rehabilitation. Evidence supports the general effectiveness of physical rehabilitation in improving TBI outcomes (Bland,. Zampieri ...
Traumatic brain injury research aggregates rehabilitation ...
Traumatic brain injury research aggregates rehabilitation data to pinpoint the best treatments for specific patients in first-of-its-kind study.
6.
medicine.musc.edu
medicine.musc.edu/departments/public-health-sciences/research-scholarship/epidemiology-research/sctbifr/backgroundSCTBIFR: Background, Methods, & Select Findings
This study focused on people hospitalized with TBI and was funded by CDC from 1995 through early 2001 through a collaboration with the Colorado Department of ...
Functional Outcomes Over the First Year After Moderate to ...
The percentage of participants with severe TBI and a favorable outcome nearly quadrupled from 12% at 2 weeks to 45% at 3 months, compared with ...
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