Web-based mind-body treatment to enhance resilience among patients with painful nontraumatic upper extremity conditions and comorbid risky substance use

项目摘要 该K23提案详细介绍了一个为期4年的综合培训计划，该计划将支持候选人向独立的临床研究职业生涯过渡，重点是开发和严格测试骨科和其他昂贵的肌肉骨骼疾病的可扩展，技术增强的身心干预措施。在这份申请中，候选人提出了一个重要的和创新的建议，与他提出的培训和职业发展目标直接相关。背景：疼痛的非创伤性上肢退行性疾病是常见的，危险物质的使用通常发生在这些条件。当这些同时发生时，疼痛和残疾的风险增加，这是一个挑战性的治疗。迄今为止，还没有循证干预措施，重点是适应这些痛苦的条件。最佳恢复工具包（TOR）是一个简短的实时视频身心计划，旨在预防急性损伤患者的慢性疼痛，适合适应患有疼痛的非创伤性退行性上肢疾病和危险物质使用的患者的需求。具体目的和研究设计：拟定研究旨在：I）通过现场视频焦点小组，确定在门诊骨科寻求治疗的患有非创伤性疼痛、上肢疾病（使用危险物质）的成人（18岁以上）新患者的治疗需求和偏好（N=3组;最多N=20例患者），告知异步基于Web的TIRELESS和研究程序的开发; 2）开展开放试点，初步探索Web-TIRELESS及其研究方法的可行性、可接受性和可信度（N=12例患者）使用前/后测试和离职面谈; 3）进行Web-TIRELESS与Web-MEUC（N=50）的可行性RCT，以确定1）招募、筛选、合格性、入组、随机化的可行性，2）Web-TIRELESS和Web-MEUC的可行性和可接受性。研究结果将通过ROI机制为疗效试验提供信息。培训和指导：学习目标由3个主要培训目标支持，旨在发展以下方面的专业知识： 1)定性和混合方法研究技能（Vranceanu）; 2）在01 thopedics进行身心临床试验（Vranceanu，Ring，Chen，Ditre）; 3）开发异步基于Web的平台和移动健康方法（Sylvia，Vranceanu）。导师的多学科团队将监督项目的进展，并提供1）丰富的机构环境，2）有针对性的课程，科学会议，研讨会和计划出版物。与NCCIH使命的相关性：这一K23提案符合NCCIH的“全人健康研究”和“疼痛的补充和综合管理”的资助优先事项。影响：总的来说，在这个奖项期间获得的经验将作为申请人的独立职业生涯的基础，开始一系列研究，重点是开发和测试可扩展的，技术增强的，身心干预骨科和共病物质使用条件。

Project Summary This K23 proposal details a comprehensive 4-year training program that will support the candidate's transition toward an independent clinical research career focused on the development and rigorous testing of scalable, technology-enhanced, mind-body interventions for orthopedic and other costly musculoskeletal conditions. In this application, the candidate proposes a significant and innovative proposal that is directly tied with his proposed training and career development goals. Background: Painful nontraumatic degenerative upper extremity conditions are common and risky substance use commonly occurs in these conditions. When these co-occur, there is an increased risk for higher pain and disability, which are challenging to treat. To date, there are no evidence-based interventions focused on adapting to these painful conditions. 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 patients with painful nontraumatic degenerative upper extremity conditions and risky substance use. Specific aims and research design: The proposed study aims to I) identify treatment needs and preferences of adult (18+) new patients with non-traumatic painful, upper extremity conditions with risky substance use who seek care in the outpatient orthopedic department, via live video focus groups (N=3 groups; up to N=20 patients) to inform the development of the asynchronous Web-based TIRELESS and study procedures; 2) conduct an open pilot to explore initial feasibility, acceptability, and credibility of Web-TIRELESS and study methods (N=12 patients) using pre/post- tests and exit interviews; 3) conduct a feasibility RCT of Web-TIRELESS vs. Web-MEUC (N=50) to determine 1) feasibility of recruitment, screening, eligibility, enrollment, randomization, and assessment processes, and 2) feasibility and acceptability of the Web-TIRELESS and Web-MEUC. Findings will inform an efficacy trial through the ROI mechanisms. Training and mentoring: Study aims are supported by 3 main training goals aimed at developing expertise in 1) qualitative and mixed methods research skills (Vranceanu); 2) conduct of mind-body clinical trials in 01thopedics (Vranceanu, Ring, Chen, Ditre); and 3) development of asynchronous Web-based platforms and mHealth approaches (Sylvia, Vranceanu). The multidisciplinary team of the mentors will oversee the progress of the project and provide 1) a rich institutional environment, and 2) targeted coursework, scientific meetings, seminars and planned publications. Relevance to the NCCIH mission: This K23 proposal is in line with NCCIH's funding priorities of "research on whole person health," and "complementary and integrative management of pain". Impact: Collectively, the experience gained during this award will serve as the foundation for the applicant's independent career to start a line of research focused on the development and testing of in scalable, technology-enhanced, mind-body interventions for orthopedic and comorbid substance use conditions.