Recruiting
Phase 1

TBI Support Program

Sponsor:

Washington University School of Medicine

Code:

NCT07625098

Conditions

TBI Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

SUPPORT-TBI

Study Details

Brief summary:

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.

Conditions

TBI Traumatic Brain Injury

Study ID

NCT07625098

Start date

Aug 17, 2026

Status verified date

May, 2026

Completion date

Mar 31, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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) ]
  • Pittsburgh Rehabilitation Participation Scale [ Time Frame: Immediately at the conclusion of each intervention session (included as part of the interventionist's session documentation) ]
  • Study-specific fidelity checklist [ Time Frame: Immediately at the conclusion of each intervention session (included as part of the interventionist's session documentation) ]

Central Contacts and Locations

Central contacts

Jessica Kersey, PhD, OTR/L

3142737540jkersey@wustl.edu

Curtis Comer, Clinical Research Coordinator I

3142733288curtisccomer@wustl.edu

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Jessica Kersey, PhD, OTR/L

3142737540jkersey@wustl.edu

Curtis Comer, Clinical Research Coordinator I

jkersey@wustl.edu

Principal Investigator:

Jessica Kersey

More Information

Sponsor

Washington University School of Medicine

Last update posted

Aug 19, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-08-19.