NCT07625098 · Washington University School of Medicine
Feasibility of SUPPORT-TBI
What this study is about
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.
View original scientific 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
BEHAVIORAL
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 measures
HEAL Treatment Expectancy Short Form
Time frame: Immediately 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 Scale
Time frame: Immediately 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 checklist
Time frame: Immediately 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- St Louis, Missouri
Collaborators
National Center for Advancing Translational Sciences (NCATS)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 19, 2026 · Source of record for eligibility and locations