Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE) RCT

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

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.

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 rehabilitation combined with behavioral management (physical activity, sleep, nutrition, hydration) is effective in improving 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 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 symptom domains in psychological health. Our overarching hypothesis is that a combined, brief (<4 weeks) intervention involving both ACT and integrated usual care rehabilitation will reduce symptoms, impairment, and functional limitations, and accelerate return to activity among military SMs and civilians following mTBI compared to usual care rehabilitation (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 impairment following mTBI.

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.
• 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.

Exclusion Criteria:

• 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.