Agile Development of a Digital Exposure Treatment for Youth with Chronic Musculoskeletal Pain

摘要 慢性肌肉骨骼疼痛(MSK)影响着超过四分之一的年轻人的生活，社会成本超过 美国每年195亿美元。青春期慢性MSK疼痛的影响会在成年后感受到 并且是阿片类药物滥用的有据可查的风险。有许多有效的行为干预措施可以帮助你 青少年患有慢性疼痛，但存在许多获得护理的障碍，突出了发展的迫切需要 通过数字方式提供行为干预，大幅扩大覆盖范围。分级暴露是一种理论- 通过以下方式为慢性疼痛患者提供个性化的驱动型干预措施 使患者暴露在以前害怕和避免的活动中。该项目旨在开发和评估 青少年慢性阻塞性肺疾病数字暴露治疗的可行性和初步效果 肌肉骨骼(MSK)疼痛及其父母，采用序贯重复随机单病例研究 实验设计(SCED)和纳入远程生物力学评估的创新技术。 中心假设是Iget Living对于患有慢性MSK疼痛的年轻人来说是可以接受和可行的，他们 它将有效地减轻功能残疾和疼痛相关的痛苦。敏捷的研究方法 将允许对干预措施进行快速、迭代的开发和评估，从而产生临床有用的解决方案。 该建议包括在具有跨专业知识的导师的指导下的全面培训计划 目标。哈里森博士将接受1)以用户为中心的数字设计和敏捷开发方面的专门培训 干预措施，2)临床研究和试验执行，3)干预措施优化、传播和 实施科学，4)创新的远程生物力学功能评估，5)高级定性 和定量统计，以及6)赠款写作中的体验式学习。研究：目标1：在迭代中，用户- 体验设计过程中，哈里森博士和她的团队将为患有慢性疾病的青少年开发Iget Living MSK Pain和他们的父母。关于全面性和可接受性的数据将通过访谈收集 和病人和父母在一起。儿科慢性疼痛的专业临床医生将就提供者如何提供反馈 可能会融入到实践中，他们会推荐谁，以及使用的潜在障碍。目标2：哈里森博士将 评估Iget Living减少疼痛相关痛苦和功能障碍的初步可行性和有效性 残疾利用多项措施的SCED。成功完成这些目标将提供机会 快速评估治疗效果并通知Iget Living迭代开发准备 随后的随机对照试验。强大的导师团队，专业化的职业发展培训，并提出 研究计划将使哈里森博士获得寻求R级资金所需的专业知识，并实现她的长期- 职业生涯目标：成为一名独立的临床医生--具有开发数字干预技术的专业知识的科学家 为患有慢性疼痛的青少年和他们的父母提供。

Abstract Chronic musculoskeletal (MSK) pain affects the lives of over a quarter of youth, with societal costs exceeding $19.5 billion dollars in the U.S. each year. The impact of chronic MSK pain in adolescence is felt into adulthood and is a documented risk for opioid misuse. There are a number of efficacious behavioral interventions for adolescents with chronic pain, but many access-to-care barriers exist, highlighting the critical need to develop digitally delivered behavioral interventions to drastically increase reach. Graded exposure is a theory- driven, individually-tailored intervention for individuals with chronic pain targeting pain-related impairment by exposing patients to previously feared and avoided activities. This project seeks to develop and evaluate the feasibility and preliminary effectiveness of a digital exposure treatment (iGET Living) for adolescents with chronic musculoskeletal (MSK) pain and their parents, utilizing a sequential replicated and randomized single-case experimental design (SCED) and incorporating innovative technology for remote biomechanical assessment. The central hypothesis is iGET Living will be acceptable and feasible for youth with chronic MSK pain and their parents and will be effective at alleviating functional disability and pain-related distress. Agile research methods will allow for a rapid, iterative development and evaluation of the intervention, yielding a clinically useful solution. This proposal includes a comprehensive training plan under the guidance of mentors with expertise across study aims. Dr. Harrison will obtain specialized training in 1) user-centered design and agile development of digital interventions, 2) clinical research and trial execution, 3) intervention optimization, dissemination, and implementation science, 4) innovative, remote assessment of biomechanical function, 5) advanced qualitative and quantitative statistics, and 6) experiential learning in grant-writing. Research: Aim 1: In an iterative, user- experience design process, Dr. Harrison and her team will develop iGET Living for adolescents with chronic MSK pain and their parents. Data regarding comprehensiveness and acceptability will be collected via interviews with patients and parents. Clinicians specialized in pediatric chronic pain will provide feedback on how providers might integrate into practice, who they would refer, and potential barriers to utilization. Aim 2: Dr. Harrison will evaluate preliminary feasibility and effectiveness of iGET Living to reduce pain-related distress and functional disability utilizing SCED with multiple measures. Successful completion of these aims will provide the opportunity to rapidly evaluate treatment effectiveness and inform iterative development of iGET Living to prepare subsequent RCTs. The strong mentorship team, specialized career development training, and proposed research plan will allow Dr. Harrison to gain the expertise needed to seek R-level funding and achieve her long- term career goal of becoming an independent clinician-scientist with expertise in developing digital interventions for youth with chronic pain and their parents.