60 Participants NeededMy employer runs this trial

SUPPORT-TBI for Traumatic Brain Injury

JK
CC
Overseen ByCurtis Comer, Clinical Research Coordinator I
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 program called SUPPORT-TBI, designed to help individuals with traumatic brain injuries (TBI) enhance their relationships and social support. The program involves the person with TBI and a close friend or family member working with a therapist for 12 weekly sessions. Participants will learn communication skills, set goals together, and offer mutual support, guided by someone who has experienced a similar situation. The trial seeks individuals who had a TBI over six months ago, feel they have low social support, and live in a community setting. The goal is to determine if the program can be delivered smoothly and if participants find it beneficial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to experience this new program.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on social support and therapy, so it's unlikely that medication changes are required.

What prior data suggests that this program is safe for people with TBI?

Research has shown that the SUPPORT-TBI program offers a low-risk option. This program does not involve drug treatment; instead, it includes therapy sessions to enhance communication and support between individuals with traumatic brain injury (TBI) and their close supporters. During these sessions, participants develop communication and problem-solving skills with guidance from a therapist and a peer mentor.

Because the program is therapy-based, it avoids chemical side effects associated with medication. The primary commitment involves attending weekly sessions and engaging in activities. The program aims to be practical and beneficial for participants. Although still under evaluation, the focus remains on ensuring smooth operation and value for those involved.12345

Why are researchers excited about this trial?

Researchers are excited about SUPPORT-TBI because it offers a fresh approach to managing traumatic brain injury (TBI) by focusing on the relationship between the patient and a close supporter. Unlike standard care treatments like medications and physical therapies, SUPPORT-TBI is a dyadic intervention that emphasizes communication strategies, shared goals, and peer mentorship. This approach aims to empower both the person with TBI and their supporter to develop effective, sustainable strategies for coping and recovery, potentially improving outcomes and quality of life. By delivering this intervention through weekly interactive sessions over 12 weeks, it provides consistent support and engagement, which is a novel mechanism compared to current options.

What evidence suggests that the SUPPORT-TBI program is effective for improving social support in individuals with traumatic brain injury?

Research has shown that rehabilitation programs can help people with traumatic brain injury (TBI) enhance their social skills and daily activities. Effective communication and emotional support play a crucial role in recovery, and programs focusing on these areas appear promising. In this trial, the SUPPORT-TBI program provides weekly sessions with a therapist to develop these skills. Although specific data from this program is not yet available, similar programs have improved relationships and quality of life for TBI patients. This suggests that SUPPORT-TBI could also strengthen social connections and support for those with TBI.13567

Who Is on the Research Team?

JK

Jessica Kersey, PhD, OTR/L

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults who have experienced a traumatic brain injury and have a close friend or family member willing to participate with them. Both must be able to attend weekly sessions together.

Inclusion Criteria

Report mild-moderate TBI-related disability (score of 5 or greater) on the Glasgow Outcome Scale - Extended
Live in a community setting (not an institutional setting)
Report low social support (score of less than 50 on the MOS Social Support Survey)
See 2 more

Exclusion Criteria

Insufficient English language fluency
Active substance use disorder (meets diagnostic criteria on the PRIME-MD MINI alcohol or non-alcoholic substances modules)
Severe memory impairment (score of less than 21 on the Montreal Cognitive Assessment)
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in the SUPPORT-TBI intervention, which includes communication strategies, shared goals, psychosocial support, peer mentorship, and problem-solving over 12 weekly sessions.

12 weeks
12 visits (in-person)

Follow-up

Participants are monitored for satisfaction, engagement, and fidelity of the intervention.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • SUPPORT-TBI

Trial Overview

The study tests a 12-week program where people with TBI and their supporters work with a therapist on communication, goal-setting, emotional support, and problem-solving skills. Sessions include guidance from someone who has also had a TBI.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: SUPPORT-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+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials
394
Recruited
404,000+

Citations

The Scope and Burden of Traumatic Brain Injury - NCBI

This chapter reviews the scope and burden of traumatic brain injury (TBI), including the frequency of injury among segments of the global and US populations.

Transforming Research and Clinical Knowledge in TBI

TBI is a contributing factor in a third of all injury-related US deaths. An estimated 3.2 to 5.3 million people live with the long-term physical, cognitive, and ...

Study Details | NCT07625098 | Feasibility of SUPPORT-TBI

This study will produce feasibility data and clinical outcome data on 30 participants with brain injury and 30 support providers, comprising ...

Traumatic brain injury: progress and challenges in ...

Around 50% of adult patients with mild TBI presenting to hospital do not recover to pre-TBI levels of health by 6 months after their injury. Fewer than 10% of ...

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 ...

Health Disparities in TBI | Traumatic Brain Injury & ...

American Indian/Alaska Native people and older adults (age 75 and older) have the highest rates of TBI-related hospitalization and death.

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 ...