Clinical trial Recruiting at 1 site Phase 1 Interventional Ages 18 and up

Support-TBI: Testing a partner-based program to help people with traumatic brain injury stay connected

Official title: From Isolation to Connection: A Dyadic Approach to Enhancing Health After TBI

Run by Washington University School of Medicine · NCT07625098 · Data updated 2026-11-12

A small pilot test will see if a partnered person with TBI and a close supporter can successfully participate in a 12-week program to improve social support and daily life participation.

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment60 (estimated)
SponsorWashington University School of Medicine
Academic / other
Locations1 site (St Louis, Missouri)
StatusRecruiting
StartedAugust 17, 2026
Main results expectedDecember 31, 2027
Study endsMarch 31, 2028
Registry record updatedAugust 19, 2026
Trial IDNCT07625098 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (18+) with a recent TBI (more than 6 months post-injury) who have mild-moderate disability and low social support, living in the community with a willing close partner or friend.

Probably not a fit

People without a close support person or those with high social support at baseline may derive less benefit from this dyadic approach.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 pilot assesses the feasibility of the SUPPORT-TBI program, which pairs a person with TBI with a close family member or friend to work with a therapist over 12 weekly sessions. The aim is to determine whether the program can be delivered smoothly, whether participants attend and stay engaged, and whether the approach is considered worthwhile by those involved. The intervention focuses on communication, shared goal setting, emotional support, and problem-solving, with guidance from a peer mentor who has a similar experience. Eligibility includes adults with TBI more than six months post-injury, mild-moderate disability, and low baseline social support. The study will enroll 30 dyads and will inform refinements before any larger efficacy testing.

Why it matters

Potential benefit: If feasible and acceptable, the program could improve social support and participation for people living with TBI, potentially enhancing health and quality of life.

How similar studies have gone: Prior research supports social support as a key factor for better outcomes after TBI, but this specific dyadic, therapist-guided program is a novel feasibility test.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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 Criteria:

* 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)

Where it's running

  • Washington University School of Medicine
    St Louis, Missouri, United States
    Recruiting

Study contacts

  • Principal investigator: Jessica Kersey, PhD, OTR/L — Washington University School of Medicine
  • Study coordinator: Jessica Kersey, PhD, OTR/L
  • Email: jkersey@wustl.edu
  • Phone: 3142737540

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.