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 这份K23提案详细说明了一项为期4年的综合培训计划，该计划将支持候选人过渡到独立的临床研究生涯，专注于骨科和其他昂贵的肌肉骨骼疾病的可扩展、技术增强的心身干预措施的开发和严格测试。在这份申请中，应聘者提出了一个重要的创新建议，该建议与他提出的培训和职业发展目标直接相关。背景：疼痛的非创伤性退行性上肢疾病很常见，危险物质的使用通常发生在这些疾病中。当这些同时发生时，更高的疼痛和残疾的风险增加，这对治疗具有挑战性。到目前为止，还没有以证据为基础的干预措施侧重于适应这些痛苦的条件。最佳恢复工具包(TOR)是一个简短的、现场直播的心身视频程序，旨在预防急性损伤患者的慢性疼痛，适合于适应患有痛苦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。具体目标和研究设计：拟议的研究旨在：i)通过现场视频焦点小组(N=3组；最多N=20名患者)确定成人(18+)非创伤性疼痛、上肢有危险物质使用的新患者的治疗需求和偏好，以告知基于Web的异步不知疲倦和研究程序的发展；2)进行开放试点，通过前后测试和退出访谈来探索Web不知疲倦和研究方法(N=12名患者)的初步可行性、可接受性和可信度；3)进行网络不知疲倦与网络-MEUC(N=50)的可行性RCT，以确定1)招募、筛选、资格、登记、随机化和评估过程的可行性，以及2)网络不知疲倦和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：研究目标由三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)进行01thopedics的心身临床试验(Vranceanu、Ring、Chen、Ditre)；以及3)开发基于网络的异步平台和mHealth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)有针对性的课程作业、科学会议、研讨会和计划出版。与NCCIH的任务相关：这项K23建议符合NCCIH的资金优先事项，即“关于全人健康的研究”和“互补和综合的疼痛管理”。影响：总的来说，在此奖项中获得的经验将作为申请者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、针对骨科和共病物质使用条件的心身干预措施。

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.