Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE) RCT
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-49
SponsorUniversity of Pittsburgh
About this trial
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.
Eligibility criteria
Qualifiers
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.
mTBI-related symptoms and/or impairments in at least one or more areas, including vestibular (dizziness, imbalance), psychological health (anxiety, depression, stress), cognitive (memory problems), headache/migraine, ocular, or sleep. as determined by self-report.
Disqualifiers
History of vestibular disorder (e.g., benign paroxysmal positional vertigo, unilateral or bilateral vestibular hypofunction) as determined by patient self-report.
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.
Trial design
Treatments tested in this trial
- Acceptance and Commitment Therapy Integrated Rehabilitation (ACT)
- Usual Care Rehabilitation
Treatment groups
250 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Pittsburgh
Lead sponsor
United States Department of Defense
Collaborator
Source ClinicalTrials.gov