Clinical trial NCT06819904: Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE) RCT
Official title: Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE) for mTBI: A Targeted Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Concussion, Mild
Mild Traumatic Brain Injury (mTBI)
Vestibular
Psychological Health
Keywords: concussion
mTBI
vestibular
psychological health
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2025-02-11
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The current study will employ a single blinded, two-group repeated measures (baseline, 4-week, 3-month, 6-month) design with permuted block random assignment to ACTIVE and Vestib Control groups.
Primary purpose: TREATMENT

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 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.

Detailed description: Nearly 378,000 mTBIs have occurred among U.S. military service members (SM) since 2000. These injuries result in myriad symptoms (e.g., dizziness, headache, fogginess) and impairments (e.g., cognitive, ocular, vestibular) that typically resolve within a month. However, many SMs experience symptoms and impairment lasting months or longer, resulting in limited operational readiness and duty restrictions. As such, one of the challenges related to mTBI and psychological health issues in military SMs is identifying and implementing timely and effective treatments that address these symptoms in an integrated manner and mitigate downstream problems.

Interventions are needed to target comorbid mTBI and psychological health symptoms. Previous research suggests that targeted vestibular rehabilitation combined with behavioral management (physical activity, sleep, nutrition, hydration) is effective in improving vestibular symptoms and associated functional impairment and reducing recovery time following mTBI. Acceptance and Commitment Therapy (ACT) is a trans-diagnostic cognitive-behavioral therapy based on incorporation of mindfulness and acceptance-based work into traditional behavior therapy. ACT is designed to improve psychological health, functioning, and well-being by improving psychological flexibility or the ability to remain present in the moment despite emotional distress.

There is separate evidence for the effectiveness of targeted vestibular rehabilitation combined with behavioral management interventions, and ACT in regard to enhancing recovery from mTBI and PH, respectively. However, researchers have yet to synergize these approaches to evaluate their effectiveness in military SMs following mTBI involving vestibular and psychological health domains. Our overarching hypothesis is that a combined, brief (\<4 weeks) intervention involving both ACT and integrated vestibular rehabilitation (ACTIVE) will reduce symptoms, impairment, and functional limitations, and accelerate return to activity among military SMs and civilians following mTBI with vestibular symptoms/impairment compared to usual care vestibular rehabilitation (VESTIB CONTROL). The investigators believe that the potential synergy of these combined interventions could provide a more efficient and effective treatment strategy that could mitigate downstream psychological health morbidity in the estimated 60-65% of SMs with vestibular symptoms and impairment following mTBI.

Eligibility criteria: Inclusion 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)

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Dizziness Handicap Inventory (DHI)
timeFrame: Baseline, 4-week, 3-month, 6-month study visits
measure: Generalized Anxiety Disorder (GAD-7)
timeFrame: Baseline, 4-week, 3-month, 6-month study visits
Secondary outcomes:
measure: Ohio State University TBI Identification short form (OSU TBI-ID)
timeFrame: Baseline
measure: Dynamic Visual Acuity Test (DVAT)
timeFrame: Baseline
measure: Dizziness Numerical Rating Scale (DNRS)
timeFrame: Baseline
measure: Visual Vertigo Analog Scale (VVAS)
timeFrame: Baseline
measure: Concussion Clinical Profiles Screening (CP-Screen)
timeFrame: Baseline
measure: Vestibular/Ocular Motor Screening (VOMS) - Change from Baseline in Symptom Reporting at 4-weeks
timeFrame: Baseline, 4-week
measure: Vestibular/Ocular Motor Screening (VOMS) - Change from Baseline in Convergence Measurement at 4-Weeks
timeFrame: Baseline, 4-week
measure: Modified Balance Error Scoring System (mBESS) - Change from Baseline in Total Errors at 4-weeks
timeFrame: Baseline, 4-week
measure: Neurobehavioral Symptom Inventory (NSI)
timeFrame: Baseline, 4-week, 3-month, 6-month study visits
measure: Patient Health Questionnaire 9 (PHQ-9)
timeFrame: Baseline, 4-week, 3-month, 6-month study visits
measure: DSM-Cross Cutting Symptom Measure - Adult (DSM-CCSM-A)
timeFrame: Baseline, 4-week, 3-month, 6-month study visits
measure: PTSD Checklist (PCL-5)
timeFrame: Baseline, 4-week, 3-month, 6-month study visits
measure: World Health Organization Disability Assessment Schedule 2 (WHODAS 2.0)
timeFrame: Baseline, 4-week, 3-month, 6-month study visits
measure: Acceptance and Action Questionnaire - Version 2 (AAQ-II)
timeFrame: Baseline, 4-week, 3-month, 6-month study visits
measure: Work and Social Adjustment Scale (WSAS)
timeFrame: Baseline, 4-week, 3-month, 6-month study visits
measure: Patient Global Impression of Change (PGIC)
timeFrame: 4-week, 3-month, 6-month study visits
measure: Return to Duty (RTD)/Return to Activity (RTA) Status
timeFrame: Baseline, 4-week, 3-month, 6-month study visits
measure: I-Portal Portable Assessment System (I-PAS) - Eye Movements
timeFrame: Baseline, 4-week
measure: I-Portal Portable Assessment System (I-PAS) - Symptoms
timeFrame: Baseline, 4-week
measure: Fitbit Activity
timeFrame: Daily, starting at Baseline and ending at 4-week
measure: Fitbit Activity - Step Counts
timeFrame: Daily, starting at Baseline and ending at 4-week
measure: Fitbit Activity - Heart Rate
timeFrame: Daily, starting at Baseline and ending at 4-week
measure: Fitbit Activity - Sleep
timeFrame: Daily, starting at Baseline and ending at 4-week
measure: Fitbit Activity - Daily Activity
timeFrame: Daily, starting at Baseline and ending at 4-week
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Concussion Research Laboratory
state: Pennsylvania
city: Fort Cavazos
country: United States
facility: Intrepid Spirit Center, Carl R. Darnall Army Medical Center
state: Texas
Study officials:
affiliation: University of Pittsburgh
name: Anthony Kontos, PhD
role: PRINCIPAL_INVESTIGATOR
References: