Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE) RCT

University of Pittsburgh

Status: Enrolling

Conditions: Psychological Health; Mild Traumatic Brain Injury (mTBI); Concussion, Mild; Vestibular

Treatments: Behavioral: Usual Care Vestibular Rehabilitation; Behavioral: Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE)

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT06819904

HT94252320064 (Other Grant/Funding Number)

STUDY24040027

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 49 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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250 participants in 2 patient groups

Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE)

Experimental group

Description:

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.

Treatment:

Behavioral: Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE)

Usual Care Vestibular Rehabilitation (VESTIB CONTROL)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Usual Care Vestibular Rehabilitation