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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 49
Healthy Volunteers: f
View:

• 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)

Locations
United States
Pennsylvania
University of Pittsburgh Concussion Research Laboratory
RECRUITING
Pittsburgh
Texas
Intrepid Spirit Center, Carl R. Darnall Army Medical Center
NOT_YET_RECRUITING
Fort Hood
Contact Information
Primary
Anthony Kontos, PhD
akontos@pitt.edu
814-615-2163
Backup
Courtney Perry, MS
cap236@pitt.edu
412-904-1298
Time Frame
Start Date: 2025-02-27
Estimated Completion Date: 2027-08
Participants
Target number of participants: 250
Treatments
Experimental: Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE)
The ACTIVE intervention group will receive Acceptance and Commitment Therapy (ACT) + targeted vestibular rehabilitation exercises and behavioral management during four weekly in person sessions along with daily at-home activities during the 4 week treatment period. The four ACTIVE sessions will last 90 minutes and will be divided between the vestibular rehabilitation portion (30 minutes) and the ACT portion (60 minutes). ACT component and therapy sessions will include: 1) values clarification and goal setting; 2) skills training in psychological flexibility including emotional acceptance, cognitive defusion, and present moment awareness; and 3) practice engaging these skills to overcome mental obstacles to values-driven goal attainment.
Active_comparator: Usual Care Vestibular Rehabilitation (VESTIB CONTROL)
The VESTIB CONTROL group will receive standard of care evaluations and treatments involving a holistic multidisciplinary approach, which includes vestibular rehabilitation, but will exclude any ACT components. Because usual standard of care is individualized to the patient's unique functional deficits, treatments combined with vestibular rehabilitation may focus on any one or more of the following: neuro-optometry, neuropsychology, physical and occupational therapy, or speech and language pathology, or general mental health interventions such as instruction regarding stress reduction. Participants will attend 4 weekly in-person visits for vestibular rehab, as well as any other interventions provided to them by their treating clinician.
Related Therapeutic Areas
Sponsors
Collaborators: United States Department of Defense
Leads: University of Pittsburgh

This content was sourced from clinicaltrials.gov