Feasibility of SUPPORT-TBI for Traumatic Brain Injury

This study is testing a new program called SUPPORT-TBI for people who have had a traumatic brain injury (TBI) and their close supporters. Many people with TBI struggle with social connections, which can affect their health and quality of life. The SUPPORT-TBI program involves 12 weekly sessions where you and a close supporter (like a family member or friend) will work with a therapist to improve communication, set shared goals, and solve problems together. A peer mentor who has experienced TBI will also offer guidance. This study aims to see if this program is practical to deliver. You may be able to join if you are 18 or older, live in the community, had a TBI over 6 months ago, and report mild-to-moderate TBI-related disability and low social support. The study will measure how well the program is delivered and how participants engage with it.

Study design
This interventional study plans to enroll 60 participants. It is not specified if it is randomized or blinded.
What's involved
You and a close supporter will complete 12 weekly intervention sessions. Your participation and engagement will be documented at the end of each session.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

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NCT07625098

Feasibility of SUPPORT-TBI

Recruiting
PHASE1Ages 18+InterventionalTreatment
Washington University School of Medicine
~60 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:SUPPORT-TBI

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
HEAL Treatment Expectancy Short Form
Measured over Immediately at the conclusion of each intervention session (included as part of the interventionist's session documentation)
+2 more outcomes measured
TBI Traumatic Brain Injury
1 sites across 1 states
Missouri1
  • Jessica Kersey, PhD, OTR/L · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine

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Eligibility criteria

Inclusion

Age 18 or older
Live in a community setting (not an institutional setting)
Sustained a traumatic brain injury more than 6 months prior to enrollment
Report mild-moderate TBI-related disability (score of 5 or greater) on the Glasgow Outcome Scale - Extended
Report low social support (score of less than 50 on the MOS Social Support Survey)

Exclusion

Insufficient English language fluency
Active substance use disorder (meets diagnostic criteria on the PRIME-MD MINI alcohol or non-alcoholic substances modules)
Active, untreated psychotic disorder (meets diagnostic criteria on the PRIME-MD MINI psychotic disorders module)
Severe memory impairment (score of less than 21 on the Montreal Cognitive Assessment)
  • HEAL Treatment Expectancy Short FormImmediately at the conclusion of each intervention session (included as part of the interventionist's session documentation)

    6-item measure of intervention satisfaction with a 5-point Likert scale (range 6-30).

  • Pittsburgh Rehabilitation Participation ScaleImmediately at the conclusion of each intervention session (included as part of the interventionist's session documentation)

    Measure of engagement in intervention sessions (range 1-6); administered each session and combined into an intervention-wide engagement score.

  • Study-specific fidelity checklistImmediately at the conclusion of each intervention session (included as part of the interventionist's session documentation)

    Checklist measuring the percentage of adherence to the outlined intervention elements; administered each session and combined into an intervention-wide adherence rate.