Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE) for mTBI: A Targeted Randomized Controlled Trial
University of Pittsburgh
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.
Description
Nearly 378,000 mTBIs have occurred among U.S. military service members (SM) since 2000. These injuries result in myriad symptoms (e.g., dizziness, headache, fogginess) and impairments (e.g., cognitive, ocular, vestibular) that typically resolve within a month. However, many SMs experience symptoms and impairment lasting months or longer, resulting in limited operational readiness and duty restrictions. As such, one of the challenges related to mTBI and psychological health issues in military SMs is identifying and implementing timely and effective treatments that address these symptoms in an i…
Eligibility
- Age range
- 18–49 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- BehavioralAcceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE)
Participants will receive the ACT treatment. It is comprised of three processes: Open Up, Be Present, and Do What Matters. Each of these is further sub-divided, for a total of six core processes. These processes include, but are not limited to, present moment awareness, de-fusion, and committed action. This group will also receive targeted vestibular therapy and standardized behavioral management strategies (physical activity, sleep, hydration, and nutrition prescription). Participants will also receive usual care at the discretion of each site's treating providers. They will also receive vestibular therapy that may include one or more exercises in the following groups: 1) gaze stability, 2) visual-vestibular habituation, and 3) balance/gait.
- BehavioralUsual Care Vestibular Rehabilitation
Participants will receive usual care at the discretion of each site's treating providers, excluding any components associated with ACT. They will also receive vestibular therapy that may include one or more exercises in the following groups: 1) gaze stability, 2) visual-vestibular habituation, and 3) balance/gait.
Locations (2)
- University of Pittsburgh Concussion Research LaboratoryPittsburgh, Pennsylvania
- Intrepid Spirit Center, Carl R. Darnall Army Medical CenterFort Hood, Texas