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 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.
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
June 30, 2026
June 1, 2026
2.2 years
May 6, 2024
June 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Neurobehavioral Symptom Inventory (NSI)
The NSI is a 22-item symptoms scale in which participants rate the severity of symptoms on a 5-point scale (0=none, 1= mild, 2=moderate, 3=severe, 4=very severe) Scores range from 0 to 60. The NSI takes approximately 5-10 minutes to administer. NSI total score changes will be analyzed between Baseline to 4-weeks to 3-months and to 6-months.
Baseline, 4-week, 3-month, 6-month study visits
Secondary Outcomes (22)
Ohio State University TBI Identification short form (OSU TBI-ID)
Baseline
Dizziness Handicap Inventory (DHI)
Baseline, 4-week, 3-month, 6-month study visits
Concussion Clinical Profiles Screening (CP-Screen)
Baseline
Vestibular/Ocular Motor Screening (VOMS) - Change from Baseline in Symptom Reporting at 4-weeks
Baseline, 4-week
Vestibular/Ocular Motor Screening (VOMS) - Change from Baseline in Convergence Measurement at 4-Weeks
Baseline, 4-week
- +17 more secondary outcomes
Study Arms (2)
Acceptance and Commitment Therapy Integrated Rehabilitation (ACT)
EXPERIMENTALThe ACT intervention group will receive Acceptance and Commitment Therapy (ACT) + usual care 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 ACT sessions will last 60 minutes each and 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 Rehabilitation (CONTROL)
ACTIVE COMPARATORThe CONTROL group will receive standard of care evaluations and treatments involving a holistic multidisciplinary approach, but will exclude any ACT components. Because usual standard of care is individualized to the patient's unique functional deficits, treatments may focus on any one or more of the following: vestibular, rehabilitation, neuro-optometry, neuropsychology, physical and occupational therapy, or speech and language pathology, or general mental health interventions such as instruction regarding stress reduction. The usual care intervention will be coordinated by a primary treating clinician and additional specialty care providers as indicated by the participant's evaluation, individualized patient goals, and concomitant treatments.
Interventions
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.
Participants will receive usual care treatment at the discretion of each site's treating providers, excluding any components associated with ACT. Because usual standard of care is individualized to the patient's unique functional deficits, treatments may focus on any one or more of the following: vestibular rehabilitation, neuro-optometry, neuropsychology, physical and occupational therapy, or speech and language pathology, or general mental health interventions.
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.
- 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.
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
Condition 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
June 30, 2026
Record last verified: 2026-06
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).