Feasibility of SUPPORT-TBI

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT07625098
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • TBI Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Jun 1, 2026
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Mar 31, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: SUPPORT-TBI
    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.

Primary Outcome Measure

HEAL Treatment Expectancy Short Form [ Time Frame: Immediately at the conclusion of each intervention session (included as part of the interventionist's session documentation) ]

Central Contacts

Locations (1)

FacilityCityStateZIP
Washington University School of MedicineSt LouisMissouri63110

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