Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE) RCT
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Acceptance and Commitment Therapy Integrated Rehabilitation (ACT), Usual Care Rehabilitation.
- Кому может быть актуально
- Состояния в реестре: Concussion, Mild, Mild Traumatic Brain Injury (mTBI), Psychological Health. Базовые параметры: 18 лет — 49 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE) for mTBI: A Targeted Randomized Controlled Trial
Обзор
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.
Подробное описание
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.
Вмешательства
- Поведенческое Acceptance and Commitment Therapy Integrated Rehabilitation (ACT)
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 - Поведенческое Usual Care Rehabilitation
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.
Первичные конечные точки
- Generalized Anxiety Disorder (GAD-7) [Срок оценки: Baseline, 4-week, 3-month, 6-month study visits]
- Neurobehavioral Symptom Inventory (NSI) [Срок оценки: Baseline, 4-week, 3-month, 6-month study visits]
Вторичные конечные точки (12)
- Ohio State University TBI Identification short form (OSU TBI-ID) [Срок оценки: Baseline]
- Dizziness Handicap Inventory (DHI) [Срок оценки: Baseline, 4-week, 3-month, 6-month study visits]
- Concussion Clinical Profiles Screening (CP-Screen) [Срок оценки: Baseline]
- Vestibular/Ocular Motor Screening (VOMS) - Change from Baseline in Symptom Reporting at 4-weeks [Срок оценки: Baseline, 4-week]
- Vestibular/Ocular Motor Screening (VOMS) - Change from Baseline in Convergence Measurement at 4-Weeks [Срок оценки: Baseline, 4-week]
- Modified Balance Error Scoring System (mBESS) - Change from Baseline in Total Errors at 4-weeks [Срок оценки: Baseline, 4-week]
- Patient Health Questionnaire 9 (PHQ-9) [Срок оценки: Baseline, 4-week, 3-month, 6-month study visits]
- DSM-Cross Cutting Symptom Measure - Adult (DSM-CCSM-A) [Срок оценки: Baseline, 4-week, 3-month, 6-month study visits]
- PTSD Checklist (PCL-5) [Срок оценки: Baseline, 4-week, 3-month, 6-month study visits]
- World Health Organization Disability Assessment Schedule 2 (WHODAS 2.0) [Срок оценки: Baseline, 4-week, 3-month, 6-month study visits]
- Acceptance and Action Questionnaire - Version 2 (AAQ-II) [Срок оценки: Baseline, 4-week, 3-month, 6-month study visits]
- Work and Social Adjustment Scale (WSAS) [Срок оценки: Baseline, 4-week, 3-month, 6-month study visits]
Критерии участия
Критерии включения
- 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.
Критерии исключения
- 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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Лечение
Центры проведения
США · 2 центра
- University of Pittsburgh Concussion Research Laboratory — Pittsburgh
- Intrepid Spirit Center, Carl R. Darnall Army Medical Center — Fort Hood
Идентификаторы
NCT: NCT06819904 · STUDY24040027 · HT94252320064