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NCT06819904 · ClinicalTrials.gov registry record · NA
Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE) RCT
A NA study of Concussion, Mild and Mild Traumatic Brain Injury (mTBI), sponsored by University of Pittsburgh.
- Recruiting
- Registry status
- NA
- Development phase
- 250
- Enrollment target
- 2
- Study locations
NCT06819904: Recruiting NA study of Concussion, Mild and Mild Traumatic Brain Injury (mTBI), sponsored by University of Pittsburgh.
NCT06819904 is a NA study of Concussion, Mild and Mild Traumatic Brain Injury (mTBI) that is actively recruiting participants, run by University of Pittsburgh. The registered enrollment target is 250 participants, above the 190-participant average among 18 other Concussion, Mild trials with a reported enrollment target (32% higher). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06819904, a NA study of Concussion, Mild and Mild Traumatic Brain Injury (mTBI), is actively recruiting participants, sponsored by University of Pittsburgh.
- RECRUITING
- Registry status
- NA
- Development phase
- 250 participants
- Enrollment target
- 2
- Study locations
Study Summary
The primary objective of this multi-site randomized clinical trial (RCT) is to compare Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE) with usual care vestibular rehabilitation (VESTIB CONTROL) in 250 individuals with mTBI-related vestibular symptoms attributable to mild traumatic brain injury (mTBI) treated at one of two sites (1) the University of Pittsburgh Medical Center, or (2) the Intrepid Spirit Center, Carl R. Darnall Army Medical Center, Fort Hood, Texas. Both interventions will be delivered weekly over 4 weeks. Assessments will be administered prior to the start of treatment (Baseline) and at 4-weeks, 3- and 6-months following the completion of treatment.
Primary Outcome
The GAD-7 is a seven item self-reported questionnaire that measures severity of symptoms regarding anxiety. Responses are 0 = not at all, 1 = several days, 2= more than half the days, and 3 = nearly every day. Higher scores are indicative of higher anxiety (0-4 = minimal anxiety, 5-9= mild anxiety, 10-14 =moderate anxiety, 15-21 = severe anxiety.
Conditions Studied
Interventions
- BEHAVIORAL Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE)
- BEHAVIORAL Usual Care Vestibular Rehabilitation
Study Locations (2)
Pennsylvania
- University of Pittsburgh Concussion Research Laboratory - Pittsburgh
Texas
- Intrepid Spirit Center, Carl R. Darnall Army Medical Center - Fort Hood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2025-02-27 |
| Est. Completion | 2027-08 |
| Phase | NA |
What NCT06819904 shows while recruiting
NCT06819904 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, above the 190-participant average among 18 other Concussion, Mild trials with a reported enrollment target (32% higher).
The record links to 4 conditions, with Concussion, Mild appearing as the primary indexed condition, and to 2 interventions - of which Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE) is the first listed.
NCT06819904 reports a single indexed study location in Pennsylvania, Texas.
Frequently Asked Questions
What is clinical trial NCT06819904 about?
NCT06819904 is a clinical study titled "Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE) RCT". The primary objective of this multi-site randomized clinical trial (RCT) is to compare Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE) with usual care vestibular rehabilitation (VESTIB CONTROL) in 250 individuals with mTBI-related vestibular symptoms attributable to m...
What is the current status of trial NCT06819904?
This trial is currently recruiting. It is a NA study. The enrollment target is 250 participants. The study started on 2025-02-27. Estimated completion is 2027-08.
What conditions does trial NCT06819904 study?
This clinical trial studies the following conditions: Concussion, Mild, Mild Traumatic Brain Injury (mTBI), Vestibular, Psychological Health.
What interventions are being tested in trial NCT06819904?
The interventions under investigation include: Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE) (BEHAVIORAL), Usual Care Vestibular Rehabilitation (BEHAVIORAL).
Who is sponsoring clinical trial NCT06819904?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06819904 being conducted?
This trial has 2 study locations across Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06819904's enrollment target sits among peer trials
250 5th of 18 higher than 13 of 18 other Concussion, Mild trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Concussion, Mild 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.
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