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

项目摘要 这份K23提案详细说明了一项全面的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心身干预的开发和严格测试 强调防止在疾病或受伤后从急性症状过渡到慢性症状。在此应用程序中， 应聘者提出了一项重要的创新建议，该建议与他计划的培训和职业生涯直接相关 发展目标。背景：大学年龄的人脑震荡的发生率特别高(也称为MTBI) 和焦虑。当这些同时发生时，过渡到慢性mTBI症状的风险增加，这种症状代价高昂，而且 很难治疗。到目前为止，还没有以预防慢性mTBI为重点的循证干预措施。工具包 为最佳恢复(TOR)是一个简短的，现场直播的身心视频计划，旨在预防慢性疼痛的患者 急性损伤，这是为了适应患有mTBI和焦虑的大学年龄个人的需求。特定的 目标和研究设计：这项拟议的研究旨在1)确定大学年龄人群的治疗需求和偏好 通过现场视频定性访谈(N=20)的急性mTBI和焦虑患者，以告知TOR和 研究程序；2)通过开放式试点(N=5)，通过离职面谈和自我报告前后评估，初步探索 现场视频脑震荡(TOR-C)和研究程序的可行性、可接受性和可信度，并进一步 根据需要改进干预措施；以及3)通过试点可行性RCT确定TOR-C与匹配剂量的时间 和注意力控制(N=50名参与者)，这两个项目的可行性、可接受性和可信度 确定了基准。这些发现将为通过UG3/UH3O机制进行的疗效试验以及未来的研究提供依据。 旨在将这项工作推广到其他患者群体。培训和指导：学习目标由3个主要方面支持 培训目标旨在发展以下方面的专门知识：1)身心干预适应的定性方法；2)移动健康 和基于技术的方法，以及3)进行严格的临床试验，以及临床试验的高级统计数据。这些 培训目标得到1)专家导师(Vranceanu&Yeh)、合作者(Giacino、Iverson和Macklin)、 和贡献者(Silverberg)，将监督项目的进展，2)丰富的制度环境，3)有针对性 课程作业、科学会议、研讨会和计划出版。与NCCIH任务相关。这份K23建议书 符合NCCIH的资金优先事项，为疑难问题开发可行和可接受的心身干预措施 重点是预防。影响：总体而言，在此奖项期间获得的经验将作为 申请者的独立职业生涯是在心身预防干预方面，并将开始一系列专注于 开发和测试简短、可行和可扩展的心身干预措施，重点是预防慢性病。

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.