Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE) RCT
2 other identifiers
interventional
250
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2025
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2024
CompletedFirst Posted
Study publicly available on registry
February 11, 2025
CompletedStudy Start
First participant enrolled
February 27, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2027
May 5, 2026
May 1, 2026
2.2 years
May 6, 2024
May 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Dizziness Handicap Inventory (DHI)
The DHI is a 25-item self-report measure that examines dizziness-related handicap. Each item is categorized into one of three domains: functional, emotional, or physical. The DHI was developed with the help of patients who complained of dizziness and uses a three-item response scale (Yes, Sometimes, No) scored as 4/2/0, respectively. Score range: 0-100, with higher scores indicating worse dizziness.
Baseline, 4-week, 3-month, 6-month study visits
Generalized Anxiety Disorder (GAD-7)
The GAD-7 is a seven item self-reported questionnaire that measures severity of symptoms regarding anxiety. Responses are 0 = not at all, 1 = several days, 2= more than half the days, and 3 = nearly every day. Higher scores are indicative of higher anxiety (0-4 = minimal anxiety, 5-9= mild anxiety, 10-14 =moderate anxiety, 15-21 = severe anxiety.
Baseline, 4-week, 3-month, 6-month study visits
Secondary Outcomes (24)
Ohio State University TBI Identification short form (OSU TBI-ID)
Baseline
Dynamic Visual Acuity Test (DVAT)
Baseline
Dizziness Numerical Rating Scale (DNRS)
Baseline
Visual Vertigo Analog Scale (VVAS)
Baseline
Concussion Clinical Profiles Screening (CP-Screen)
Baseline
- +19 more secondary outcomes
Study Arms (2)
Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE)
EXPERIMENTALThe 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.
Usual Care Vestibular Rehabilitation (VESTIB CONTROL)
ACTIVE COMPARATORThe 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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)
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 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pittsburghlead
- United States Department of Defensecollaborator
Study Sites (2)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anthony Kontos, PhD
University of Pittsburgh
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Director
Study Record Dates
First Submitted
May 6, 2024
First Posted
February 11, 2025
Study Start
February 27, 2025
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
August 1, 2027
Last Updated
May 5, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- De-identified data will be shared with FITBIR on an annual basis as required by the funder (DoD). Data will be entered until the study has completed. All data will be available on the FITBIR website indefinitely.
- Access Criteria
- Formal requests must be submitted and approved to FITBIR to access this study's de-identified data.
Per DoD grant requirement, de-identified data will be shared with the Federal Interagency Traumatic Brian Injury Research (FITBIR) informatics system and Congressionally Directed Medical Research Programs (CDMRP). This data includes non-identifiable demographic data, medical history, medications, and both primary and secondary outcomes (except I-PAS and Fitbit data).