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NCT07625098 · ClinicalTrials.gov registry record · Phase 1

Feasibility of SUPPORT-TBI

A Phase 1 study, sponsored by Washington University School of Medicine.

Not yet
Registry status
Phase 1
Development phase
60
Enrollment target

NCT07625098: Clinical Trial Phase 1 study, sponsored by Washington University School of Medicine.

NCT07625098 is a Phase 1 study that has not yet begun recruiting, run by Washington University School of Medicine. The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07625098, a Phase 1 study, has not yet begun recruiting, sponsored by Washington University School of Medicine.

NOT YET RECRUITING
Registry status
Phase 1
Development phase
60 participants
Enrollment target

Study 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.

Primary Outcome

6-item measure of intervention satisfaction with a 5-point Likert scale (range 6-30).

Interventions

  • BEHAVIORAL SUPPORT-TBI

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2026-06-01
Est. Completion 2028-03-31
Phase Phase 1

What is known before NCT07625098 opens enrollment

NCT07625098 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.

The record links to 0 conditions, and to 1 intervention - of which SUPPORT-TBI is the first listed.

NCT07625098 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT07625098 about?

NCT07625098 is a clinical study titled "Feasibility of SUPPORT-TBI". 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 l...

What is the current status of trial NCT07625098?

This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2026-06-01. Estimated completion is 2028-03-31.

What interventions are being tested in trial NCT07625098?

The interventions under investigation include: SUPPORT-TBI (BEHAVIORAL).

Who is sponsoring clinical trial NCT07625098?

This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT07625098's enrollment target sits among peer trials

60 831st of 2000 higher than 1,106 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT07625098, the US trial registry maintained by the National Library of Medicine. NCT07625098 (small enrollment · none site footprint · not yet recruiting) retrieved and formatted by PlainTrial, see methodology.