Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE) RCT

Recruiting now · Not applicable

Conditions studied: Concussion, Mild, Mild Traumatic Brain Injury (mTBI), Psychological Health

In brief

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.

Key facts

Study ID

NCT06819904

Run by

University of Pittsburgh

People needed

250

Starts

2025-02-27

Expected to finish

2027-08-01

Last updated by the study team

2026-06-30

Who can join

Age: 18 and older, up to 49. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• < 8 days following current mTBI as determined by self-report.
• Currently pregnant as determined by self-report.

Where it is running

• University of Pittsburgh Concussion Research Laboratory — Pittsburgh, Pennsylvania, United States (enrolling)
• Intrepid Spirit Center, Carl R. Darnall Army Medical Center — Fort Hood, Texas, United States

Full record on ClinicalTrials.gov

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