RecruitingNot Applicable

Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE) RCT

United States250 participantsStarted 2025-02-27

Plain-language 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.

Who can participate

Age range

18 Years – 49 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 18-49 years of age * Normal/corrected vision * Diagnosed with mTBI per military clinical practice guidelines (CPGs) that occurred over 8 days prior to consent as determined by a multi-domain assessment performed by a licensed healthcare professional. * Reported or observed signs of mTBI including loss of consciousness, amnesia, disorientation/confusion, dizziness, imbalance, memory problems, vomiting at the time of injury as determined by self-report. * Positive for mTBI-related vestibular symptoms and/or impairments per a concussion common data elements (CDE) assessment. Participants must demonstrate a positive finding in at least one of the following tests: DVAT (\>2 lines lost), DNRS (\>2/10 score), VVAS (\>0 on 2 or more items), VOMS (\>2 score on VOR or VMS), mBESS (\> 9 total errors), and CP-Screen (avg vestibular factor score \>/= 2 or single item = 3 severity) Exclusion Criteria: * History of vestibular disorder (e.g., benign paroxysmal positional vertigo, unilateral or bilateral vestibular hypofunction) as determined by patient self-report and/or by Physical Therapist exam. * Exercise-induced dizziness as determined by the Physical Therapist exam. * History of neurological disorder (e.g., epilepsy, multiple sclerosis) as determined by self-report. * Cervical spine injury or dysfunction (i.e., limited range of motion; ROM) as determined by self-report. * Previous moderate to severe TBI as determined by self-report. * \< 8 days following curren…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial combines vestibular rehabilitation with a psychological therapy called Acceptance and Commitment Therapy — could you explain how treating both the physical dizziness and the anxiety side of my symptoms at the same time might be different from what I'd get with standard vestibular rehab alone?
2The trial is measuring outcomes using the Dizziness Handicap Inventory and the GAD-7 anxiety scale — given my current levels of dizziness and anxiety after my concussion, do you think I'm experiencing enough of both to make this kind of combined approach relevant for me?
3Since this trial is listed as Phase NA, which often applies to behavioral or rehabilitation studies rather than drug trials, what does that mean for what's already known about the safety and effectiveness of this specific combination of therapies?
4How intensive or time-consuming is this program likely to be, and given where I am in my recovery from my mild TBI, is this something my schedule and current condition could realistically support right now?
5Would it make sense for me to try standard vestibular rehabilitation first and see how I respond, or is there a reason you'd want me to consider this trial before going that route?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Dizziness Handicap Inventory (DHI)

Timeframe: Baseline, 4-week, 3-month, 6-month study visits

Generalized Anxiety Disorder (GAD-7)

Timeframe: Baseline, 4-week, 3-month, 6-month study visits

Trial details

NCT IDNCT06819904

SponsorUniversity of Pittsburgh

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-05

Contact for this trial

Anthony Kontos, PhD

814-615-2163 akontos@pitt.edu

View on ClinicalTrials.gov More Concussion, Mild trials