Live video mind-body treatment to prevent persistent symptoms following mTBI

实时视频身心治疗可预防 mTBI 后的持续症状

• 批准号: 10054368
• 负责人: Jonathan Greenberg
• 金额: $ 15.79万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-01 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10054368
• 关键词: Acute; Adherence; Aftercare; Age; Anxiety; Attention; Award; Behavioral; Benchmarking; Brain Concussion; Chronic; Chronic Disease; Clinical; Clinical Research; Clinical Trials; Cognitive; Complex; Data Collection; Development; Dizziness; Dose; Eligibility Determination; Emotional; Enrollment; Environment; Evidence based intervention; Evidence based treatment; Foundations; Fright; Funding; Future; Goals; Headache; Health; Health Services Accessibility; Healthcare; High Prevalence; Home environment; Individual; Injury; Intervention; Interview; Link; Medical; Memory impairment; Mental Health; Mentored Patient-Oriented Research Career Development Award; Mentors; Methods; Mild Concussions; Mind-Body Intervention; Mission; Modeling; Musculoskeletal Pain; Neurologic; Orthopedics; Parents; Patient Care; Patient Self-Report; Patients; Persons; Phase; Placebo Control; Population; Post-Concussion Syndrome; Prevention; Preventive Intervention; Procedures; Process; Publications; Qualitative Methods; Qualitative Research; Recovery; Relaxation; Reporting; Research; Research Design; Research Personnel; Risk; Sleeplessness; Specific qualifier value; Symptoms; Technology; Testing; Time; Training; Training Programs; Work; age group; anxiety symptoms; attentional control; base; body-mind; career; career development; chronic pain; college; comorbidity; concussive symptom; cost; disability; efficacy trial; experience; high risk population; improved; injury recovery; innovation; mHealth; meetings; mild traumatic brain injury; mind body interaction; multidisciplinary; neuroimaging; novel; patient population; persistent symptom; physical symptom; preference; prevent; prognostic value; programs; psychologic; recruit; response; satisfaction; screening; skills; social stigma; statistics; therapy development; university student; young adult

Project Summary This K23 proposal details a comprehensive 5-year training program that will support the candidate’s transition toward an independent clinical research career focused on the development and rigorous testing of mind-body interventions with an emphasis on prevention of transition from acute to chronic symptoms following illness or injury. In this application the candidate proposes a significant and innovative proposal that is directly tied with his proposed training and career development goals. Background: College-age individuals have particularly high rates of concussions (also known as mTBIs) and anxiety. When these co-occur, there is an increased risk for transition to chronic mTBI symptoms, which are costly and challenging to treat. To date, there are no evidence-based interventions focused on preventing chronic mTBI. The Toolkit for Optimal Recovery (TOR) is a brief, live video mind-body program aimed at preventing chronic pain in patients with acute injuries, which is amenable for adaptations for the needs of college-age individuals with mTBI and anxiety. Specific aims and research design: The proposed study aims to 1) identify treatment needs and preferences among college-age individuals with acute mTBI and anxiety via live video qualitative interviews (N = 20) to inform adaptation of the TOR and study procedures; 2) explore, via an open pilot (N=5) with exit interviews and pre- and post- self-report assessments, initial feasibility, acceptability, and credibility of the live video TOR-Concussions (TOR-C) and study procedures, and to further refine the intervention, as needed; and 3) establish, via a pilot feasibility RCT of the TOR-C versus a matched dose, time and attention control (N = 50 enrolled), the feasibility, acceptability and credibility of both programs following pre- determined benchmarks. Findings will inform an efficacy trial through the UG3/UH3 o mechanisms, as well as future studies aimed at generalizing this work to other patient populations. Training and mentoring: Study aims are supported by 3 main training goals aimed at developing expertise in: 1) qualitative methods for mind- body intervention adaptation; 2) mHealth and technology-based approaches, and 3) conduct of rigorous clinical trials, and advanced statistics for clinical trials. These training goals are supported by 1) a team of expert mentors (Vranceanu & Yeh), collaborators (Giacino, Iverson & Macklin), and contributors (Silverberg) that will oversee the progress of the project, 2) a rich institutional environment, and 3) targeted coursework, scientific meetings, seminars and planned publications. Relevance to the NCCIH mission. This K23 proposal is in line with NCCIH’s funding priorities to develop feasible and acceptable mind-body interventions for difficult problems focused on prevention. Impact: Collectively, the experience gained during this award will serve as the foundation for the applicant’s independent career in mind-body preventative interventions, and will start a line of research focused on the development and testing of brief, feasible and scalable mind-body interventions with a focus on prevention of chronic illness.

项目摘要 此K23提案详细说明了一个全面的5年培训计划，该计划将支持候选人向 独立的临床研究生涯，专注于身心干预的开发和严格测试， 强调预防疾病或受伤后从急性症状转变为慢性症状。在本申请中， 候选人提出了一个重要的和创新的建议，直接与他的拟议培训和职业生涯 发展目标背景：大学年龄段的人有特别高的脑震荡率（也称为mTBI） 和焦虑当这些同时发生时，转变为慢性mTBI症状的风险增加，这是昂贵的， 到目前为止，还没有基于证据的干预措施专注于预防慢性mTBI。该工具包 最佳恢复（TOR）是一个简短的，实时视频身心计划，旨在预防慢性疼痛患者， 急性损伤，这是适合适应与mTBI和焦虑的大学年龄的个人的需要。具体 目的和研究设计：拟议的研究旨在1）确定大学年龄组的治疗需求和偏好 通过实时视频定性访谈（N = 20）对患有急性mTBI和焦虑的个体进行评估，以告知TOR的适应情况， 研究程序; 2）通过一个开放的试点（N=5），通过离职面谈和自我报告前后的评估， 可行性，可接受性，和现场视频TOR脑震荡（TOR-C）和研究程序的可信度，并进一步 根据需要完善干预措施; 3）通过TOR-C与匹配剂量的试点可行性RCT， 和注意控制（N = 50入组），两个程序的可行性，可接受性和可信度后， 确定基准。这些发现将通过UG 3/UH 3 o机制为疗效试验以及未来的研究提供信息。 旨在将这项工作推广到其他患者群体。培训和指导：研究目标由3个主要支持 培训目标旨在发展以下方面的专业知识：1）身心干预适应的定性方法; 2）移动健康 和技术为基础的方法，和3）进行严格的临床试验，和先进的临床试验统计。这些 培训目标由1）专家导师团队（Vranceanu & Yeh），合作者（Giacino，Iverson & Macklin）， 和贡献者（西尔弗伯格），将监督项目的进展，2）丰富的制度环境，3）有针对性的 课程作业、科学会议、研讨会和计划出版物。与国家儿童健康中心使命相关。K23提案 符合NCCIH的资助优先事项，以制定可行和可接受的身心干预措施，解决困难问题 注重预防。影响：总的来说，在这个奖项期间获得的经验将作为基础， 申请人在身心预防干预方面的独立职业生涯，并将开始一系列研究，重点是 制定和测试简短、可行和可扩展的身心干预措施，重点是预防慢性病。