MENTOR Wellness Program

Официальное название

Promoting Wellness in Individuals With Traumatic Brain Injury: A Randomized Trial Assessing the Effectiveness of the Mindfulness, Exercise, Nutrition to Optimize Resilience (MENTOR) Program

Обзор

This randomized trial aims to determine the effectiveness a virtual wellness intervention program in individuals with traumatic brain injury (TBI). Participants will be randomized at enrollment into two groups: immediate treatment (IT) and delayed treatment (DT) group. This study will also provide insights into the impact of these intervention's components in helping emotional, physical, and nutritional outcomes post-injury in the context of social determinants of health (SDOH).

Вмешательства

• Поведенческое MENTOR Program
  MENTOR is an online wellness program covering 11 wellness modules: Exercise; Nutrition; Mindfulness; Spiritual Practice; Self-Care; Arts \& Leisure; Rest \& Relaxation; Outdoors in Nature; Relationships; Core Values; and Contribution to Others. The 8-week cycle comprises 40 hours of online group-based instruction and discussion, meeting up to five times per week.

Первичные конечные точки

• Freiburg Mindfulness Inventory (FMI) Score at Baseline [Срок оценки: Baseline]
• Freiburg Mindfulness Inventory (FMI) Score at Post-Intervention Assessment [Срок оценки: Post-Intervention Assessment (Week 8 for IT; Week 16 for DT)]
• International Physical Activity Questionnaire (IPAQ) Score at Baseline [Срок оценки: Baseline]
• International Physical Activity Questionnaire Score at Post-Intervention Assessment [Срок оценки: Post-Intervention Assessment (Week 8 for IT; Week 16 for DT)]
• Health Promoting Lifestyle Profile II (HPLP-II) Score at Baseline [Срок оценки: Baseline]
• Health Promoting Lifestyle Profile II (HPLP-II) Score at Post-Intervention Assessment [Срок оценки: Post-Intervention Assessment (Week 8 for IT; Week 16 for DT)]
• Connor-Davidson Resilience Scale 10 (CD-RISC-10) Score at Baseline [Срок оценки: Baseline]
• Connor-Davidson Resilience Scale 10 (CD-RISC-10) Score at Post-Retention Assessment [Срок оценки: Post-Retention Period Assessment (Week 16 for IT; Week 24 for DT)]
• Perceived Stress Scale (PSS) Score at Baseline [Срок оценки: Baseline]
• Perceived Stress Scale (PSS) Score at Post-Retention Assessment [Срок оценки: Post-Retention Period Assessment (Week 16 for IT; Week 24 for DT)]

Критерии участия

Критерии включения

• Have a medically-documented (e.g., EMS report, hospital record, physician record) or per medical monitor review complicated-mild, moderate, or severe TBI requiring admission to an acute inpatient rehabilitation unit
• Be at least 12 months post-TBI
• Have access to the internet on a computer, tablet, and/or smartphone.
• Speak and understand English or Spanish
• Agree to participate
• Are medically cleared by their primary physician, physiatrist, neurologist, rehabilitation therapist, or other recognized health professional to participate in the study

Критерии исключения

• No history of complicated-mild, moderate, or severe TBI
• Less than 12 months post-TBI
• In minimally conscious or vegetative state
• Beginning a new treatment regimen (e.g., physical therapy, occupational therapy, vestibular therapy, psychotherapy, and/or medication) at study start that can influence study findings in the judgment of the principal investigator and/or medical monitor (participants whose treatment regimens are stable will be eligible)
• In the judgment of the principal investigator, medical monitor, and/or study team member, presence of significant cognitive impairment (i.e. delirium or dementia) sufficient to preclude meaningful informed consent and/or data collection
• In the judgment of the principal investigator, medical monitor, and/or study team member, significant or major disabling medical condition sufficient to preclude meaningful informed consent and/or data collection

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

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• NYU Langone Health — New York

Идентификаторы

NCT: NCT06148324 · 23-00826

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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