RECRUITING

Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE) RCT

Talk to us

Conditions

Concussion, MildMild Traumatic Brain Injury (mTBI)VestibularPsychological HealthconcussionmTBI

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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 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

Quick Facts

Study Start:2025-02-27
Study Completion:2027-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06819904

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.

Ages Eligible for Study:18 Years to 49 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18-49 years of age
  2. * Normal/corrected vision
  3. * 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.
  4. * 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.
  5. * 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)
  1. * 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.
  2. * Exercise-induced dizziness as determined by the Physical Therapist exam.
  3. * History of neurological disorder (e.g., epilepsy, multiple sclerosis) as determined by self-report.
  4. * Cervical spine injury or dysfunction (i.e., limited range of motion; ROM) as determined by self-report.
  5. * Previous moderate to severe TBI as determined by self-report.
  6. * \< 8 days following current mTBI as determined by self-report.
  7. * Currently pregnant as determined by self-report.

Contacts and Locations

Study Contact

Anthony Kontos, PhD
CONTACT
814-615-2163
akontos@pitt.edu
Courtney Perry, MS
CONTACT
412-904-1298
cap236@pitt.edu

Principal Investigator

Anthony Kontos, PhD
PRINCIPAL_INVESTIGATOR
University of Pittsburgh

Study Locations (Sites)

University of Pittsburgh Concussion Research Laboratory
Pittsburgh, Pennsylvania, 15213-4512
United States
Intrepid Spirit Center, Carl R. Darnall Army Medical Center
Fort Hood, Texas, 76544
United States

Collaborators and Investigators

Sponsor: University of Pittsburgh

  • Anthony Kontos, PhD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-27
Study Completion Date2027-08

Study Record Updates

Study Start Date2025-02-27
Study Completion Date2027-08

Terms related to this study

Keywords Provided by Researchers

  • concussion
  • mTBI
  • vestibular
  • psychological health

Additional Relevant MeSH Terms

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