Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE) RCT

Description

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 Cavazos, 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.

Conditions

Concussion, Mild, Mild Traumatic Brain Injury (mTBI), Vestibular, Psychological Health

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Study Overview

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Study Details

Study overview

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 Cavazos, 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.

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

Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE) RCT

Condition
Concussion, Mild
Intervention / Treatment

-

Contacts and Locations

Pittsburgh

University of Pittsburgh Concussion Research Laboratory, Pittsburgh, Pennsylvania, United States, 15213-4512

Fort Cavazos

Intrepid Spirit Center, Carl R. Darnall Army Medical Center, Fort Cavazos, Texas, United States, 76544

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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. 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)
  • * 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.

Ages Eligible for Study

18 Years to 49 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Pittsburgh,

Anthony Kontos, PhD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

2027-08