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

摘要 慢性肌肉骨骼（MSK）疼痛影响了超过四分之一的青年人的生活，社会成本超过 每年在美国有195亿美元。青春期慢性MSK疼痛的影响一直持续到成年 并且有记录表明有滥用阿片类药物的风险。有许多有效的行为干预措施， 患有慢性疼痛的青少年，但存在许多获得护理的障碍，突出了发展 以数字方式提供的行为干预措施，以大幅增加覆盖面。分级接触只是一种理论- 针对慢性疼痛患者的个性化干预，针对疼痛相关损害， 让患者接触到以前害怕和避免的活动。该项目旨在开发和评估 数字暴露治疗（iGET Living）对青少年慢性 肌肉骨骼（MSK）疼痛和他们的父母，利用一个连续的重复和随机单例 实验设计（SCED），并结合创新技术进行远程生物力学评估。 核心假设是iGET Living对于患有慢性MSK疼痛的青少年及其 它将有效地减轻功能性残疾和与疼痛有关的痛苦。敏捷研究方法 将允许对干预进行快速、迭代的开发和评估，从而产生临床上有用的解决方案。 该建议书包括在具有跨学科专业知识的导师指导下的全面培训计划 目标。哈里森博士将获得1）以用户为中心的设计和数字敏捷开发的专业培训 干预，2）临床研究和试验执行，3）干预优化，传播，和 实施科学，4）生物力学功能的创新性远程评估，5）先进的定性 和定量统计，以及6）在赠款写作的经验学习。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开发iGET生活的青少年慢性 麦氏疼痛和他们的父母。关于全面性和可接受性的数据将通过访谈收集 病人和家长。专门从事儿科慢性疼痛的临床医生将提供有关提供者如何 可能纳入实践，他们将推荐谁，以及潜在的利用障碍。目标2：哈里森博士将 评估iGET Living的初步可行性和有效性，以减少疼痛相关的痛苦和功能 使用SCED进行多项测量的残疾。这些目标的成功实现将提供机会， 快速评估治疗效果，并为iGET Living的迭代开发提供信息， 随后的RCT。强大的导师团队，专业的职业发展培训，并建议 研究计划将使哈里森博士获得所需的专业知识，寻求R级资金，并实现她的长期- 长期职业目标是成为一名独立的临床科学家，拥有开发数字干预措施的专业知识 为患有慢性疼痛的年轻人和他们的父母。

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.