RecruitingNot ApplicableNCT06819904

Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE) RCT

Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE) for mTBI: A Targeted Randomized Controlled Trial

Sponsor

University of Pittsburgh

Enrollment

250 participants

Start Date

Feb 27, 2025

Study Type

INTERVENTIONAL

Conditions

Concussion, Mild

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.

Eligibility

Min Age: 18 YearsMax Age: 49 Years

Inclusion Criteria5

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 Criteria7

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.

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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.