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Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE) RCT
Sponsor: University of Pittsburgh
Summary
The primary objective of this multi-site randomized clinical trial (RCT) is to compare Acceptance and Commitment Therapy Integrated Rehabilitation (ACT) with usual care rehabilitation (CONTROL) in 250 individuals with mTBI-related 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.
Official title: Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE) for mTBI: A Targeted Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 49 Years
Study Type
INTERVENTIONAL
Enrollment
250
Start Date
2025-02-27
Completion Date
2027-08
Last Updated
2026-06-30
Healthy Volunteers
No
Interventions
Acceptance and Commitment Therapy Integrated Rehabilitation (ACT)
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.
Usual Care Rehabilitation
Participants will receive usual care treatment at the discretion of each site's treating providers, excluding any components associated with ACT. Because usual standard of care is individualized to the patient's unique functional deficits, treatments may focus on any one or more of the following: vestibular rehabilitation, neuro-optometry, neuropsychology, physical and occupational therapy, or speech and language pathology, or general mental health interventions.
Locations (2)
University of Pittsburgh Concussion Research Laboratory
Pittsburgh, Pennsylvania, United States
Intrepid Spirit Center, Carl R. Darnall Army Medical Center
Fort Hood, Texas, United States