RECRUITING Phase 1 ClinicalTrials.gov

Feasibility of SUPPORT-TBI

Sponsor: Washington University School of Medicine • ClinicalTrials.gov ID: NCT07625098

Registry updated: 2026-08-19

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Description

Many people who have had a traumatic brain injury (TBI) struggle to stay connected with others. They often lose friendships, become isolated, and have strained family relationships. This lack of social support is linked to worse physical and mental health, lower quality of life, and even a shorter lifespan. The investigators developed a program where a person with TBI and one close supporter work together with a therapist over 12 weekly sessions. They learn skills in communication, setting shared goals, supporting each other emotionally, and problem-solving, with occasional guidance from a peer mentor who has been through a similar experience. This study will determine whether the program is practical to deliver. We are conducting a pilot study with 30 pairs of participants to test whether sessions run smoothly, whether people show up and stay engaged, and whether participants find the program worthwhile. Based on what they learn, the investigators will refine this program before testing it on a larger scale. If successful, this could lead to a practical, low-risk intervention that improves the lives of people with TBI and the family members and friends who support them.

Interventions

SUPPORT-TBI (Behavioral)
This novel dyadic intervention incorporates essential elements of communication strategies, shared goals and activities, psychosocial support, peer mentorship, and problem-solving. The person with TBI and a close supporter complete intervention procedures together and work to develop sustainable strategies for an effective support relationship. The intervention is delivered in weekly 1-hour sessions for 12 consecutive weeks.

Eligibility 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)

Conditions

TBI Traumatic Brain Injury

Locations

Washington University School of Medicine — St Louis, Missouri, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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