Combining Acceptance and Commitment Therapy with Vestibular Rehabilitation for mTBI
Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE) for mTBI: A Targeted Randomized Controlled Trial
This study is testing if combining a therapy that helps with acceptance and commitment with standard balance exercises can better help military service members with mild traumatic brain injury and related symptoms feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years to 49 Years |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 2 sites (Pittsburgh, Pennsylvania and 1 other locations) |
| Trial ID | NCT06819904 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE) against standard vestibular rehabilitation (VESTIB CONTROL) in individuals with mild traumatic brain injury (mTBI) and related vestibular symptoms. Conducted at two sites, the University of Pittsburgh Medical Center and the Intrepid Spirit Center, the trial will enroll 250 participants who will receive treatment over four weeks. Assessments will be conducted at baseline, and at 4 weeks, 3 months, and 6 months post-treatment to evaluate outcomes related to vestibular symptoms and psychological health. The study seeks to address the challenges faced by military service members experiencing prolonged symptoms following mTBI.
Who should consider this trial
Good fit: Ideal candidates are military service members aged 18-49 who have been diagnosed with mTBI and exhibit vestibular symptoms.
Not a fit: Patients with a history of vestibular disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve recovery outcomes for patients with mTBI by addressing both vestibular and psychological health symptoms.
How similar studies have performed: Previous studies have shown promise in combining vestibular rehabilitation with behavioral therapies, suggesting potential success for this integrated approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 current mTBI as determined by self-report. * Currently pregnant as determined by self-report.
Where this trial is running
Pittsburgh, Pennsylvania and 1 other locations
- University of Pittsburgh Concussion Research Laboratory — Pittsburgh, Pennsylvania, United States (Recruiting)
- Intrepid Spirit Center, Carl R. Darnall Army Medical Center — Fort Hood, Texas, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Anthony Kontos, PhD — University of Pittsburgh
- Study coordinator: Anthony Kontos, PhD
- Email: akontos@pitt.edu
- Phone: 814-615-2163
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.