Actively Recruiting
Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE) for mTBI: A Targeted Randomized Controlled Trial
Led by University of Pittsburgh · Updated on 2026-05-05
250
Participants Needed
2
Research Sites
13 weeks
Total Duration
On this page
Sponsors
U
University of Pittsburgh
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a combined therapy called Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE) for individuals aged 18 to 49 who have vestibular symptoms related to mild traumatic brain injury (mTBI). This trial compares ACTIVE with usual care vestibular rehabilitation (VESTIB CONTROL) to see which approach better reduces symptoms and improves recovery. The study focuses on military service members and civilians who experience ongoing dizziness and related impairments after mTBI. Participants in the ACTIVE group will receive four weekly 90-minute sessions combining Acceptance and Commitment Therapy (ACT) and targeted vestibular rehabilitation exercises, along with daily at-home activities over four weeks. The ACT component focuses on psychological flexibility and mindfulness. The comparison group will receive usual care vestibular rehabilitation and other supportive treatments excluding ACT, also delivered weekly over four weeks. Both groups will have individualized care based on their needs. Participants will be assessed before treatment and at 4 weeks, 3 months, and 6 months after treatment ends. Assessments include dizziness severity, anxiety levels, vestibular function tests, symptom questionnaires, and activity monitoring using Fitbit devices. Researchers will monitor symptoms, functional improvements, and return to activity status. The total participation period covers about six months, allowing for evaluation of both short- and longer-term outcomes.
CONDITIONS
Brief Title
Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE) RCT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 49 years
- Normal or corrected vision
- Diagnosed with mild traumatic brain injury (mTBI) per military guidelines occurring more than 8 days before consent
- Signs or symptoms of mTBI such as loss of consciousness, dizziness, amnesia, or confusion
- Positive for mTBI-related vestibular symptoms or impairments based on specific clinical tests
You will not qualify if you...
- History of vestibular disorders such as benign paroxysmal positional vertigo or vestibular hypofunction
- Exercise-induced dizziness confirmed by physical therapist exam
- History of neurological disorders like epilepsy or multiple sclerosis
- Cervical spine injury or limited range of motion
- Previous moderate to severe traumatic brain injury
- Less than 8 days since current mTBI
- Currently pregnant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants receive either the ACTIVE intervention involving Acceptance and Commitment Therapy combined with targeted vestibular rehabilitation and behavioral management, or usual care vestibular rehabilitation without ACT components. Treatment includes four weekly in-person sessions and daily at-home activities during the 4-week treatment period.
Weekly visits for 4 weeks plus daily at-home activities
Duration - Up to 5 months
Participants are monitored through study visits to assess symptoms and functional outcomes after completing treatment.
3 visits at 1 month, 3 months, and 6 months post-treatment
Trial Site Locations
Total: 2 locations
1
University of Pittsburgh Concussion Research Laboratory
Pittsburgh, Pennsylvania, United States, 15213-4512
Actively Recruiting
2
Intrepid Spirit Center, Carl R. Darnall Army Medical Center
Fort Hood, Texas, United States, 76544
Not Yet Recruiting
Research Team
A
Anthony Kontos, PhD
C
Courtney Perry, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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