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

基于网络的身心治疗，可增强患有疼痛性非创伤性上肢疾病和共病危险物质使用的患者的恢复能力

• 批准号: 10644384
• 负责人: Jafar Bakhshaie
• 金额: $ 17.02万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-04-01 至 2027-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10644384
• 关键词: Acute; Acute Pain; Address; Adult; Alcohols; Amphetamines; Award; Back; Benchmarking; Biometry; Bypass; Cannabis; Caring; Clinical; Clinical Research; Clinical Trials; Cocaine; Consumption; Data; Development; Diagnostic; Electronic cigarette; Elements; Eligibility Determination; Enhancement Technology; Enrollment; Environment; Evidence based intervention; Face; Focus Groups; Fostering; Foundations; Fright; Funding; Goals; Hallucinogens; Health; Hip region structure; Infection; Inhalant dose form; Injections; Injury; Institution; Internet; Intervention; Interview; Knee; Life; Link; Maps; Medical; Mentors; Methodology; Methods; Mind-Body Intervention; Mission; Modeling; Musculoskeletal; National Center for Complementary and Integrative Health; Online Systems; Operative Surgical Procedures; Opioid; Orthopedics; Outcome; Outpatients; Ownership; Pain; Pain management; Patients; Pattern; Persistent pain; Persons; Population; Procedures; Process Assessment; Psychologist; Publications; Qualitative Methods; Randomized; Recovery; Research; Research Design; Research Methodology; Research Personnel; Research Priority; Risk; Risk Factors; Self Efficacy; Stimulant; Substance Addiction; Tendinopathy; Testing; Thinking; Training; Training Programs; Upper Extremity; acceptability and feasibility; care costs; care seeking; care systems; career; career development; chronic pain; comorbidity; cost; disability; efficacy testing; efficacy trial; emotional distress; experience; high risk; high risk population; improved; improved outcome; injury recovery; innovation; mHealth; meetings; mind/body; multidisciplinary; novel; opioid misuse; pain catastrophizing; pain model; palliative; patient subsets; preference; prescription opioid; prescription opioid misuse; prevent; primary outcome; programs; promote resilience; psychoeducation; psychoeducational; psychosocial; recruit; resilience; screening; secondary outcome; sedative; skills; social stigma; substance use; therapy development; tobacco products; treatment as usual; user centered design; web platform; whole health

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.

项目概要 该 K23 提案详细介绍了一项为期 4 年的综合培训计划，该计划将支持候选人向独立临床研究职业过渡，重点是针对骨科和其他昂贵的肌肉骨骼疾病开发和严格测试可扩展、技术增强的身心干预措施。在此申请中，候选人提出了一项重要且创新的提案，该提案与他提出的培训和职业发展目标直接相关。背景：疼痛性非创伤性退行性上肢病症很常见，在这些病症中通常会发生危险的物质使用。当这些情况同时发生时，出现更严重的疼痛和残疾的风险就会增加，而这些都很难治疗。迄今为止，还没有针对适应这些痛苦状况的循证干预措施。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，可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。具体目的和研究设计：拟议的研究旨在 I) 通过实时视频焦点小组（N = 3 组；最多 N = 20 名患者）确定在门诊骨科寻求护理的患有非创伤性疼痛、上肢疾病和危险物质使用的成人（18 岁以上）新患者的治疗需求和偏好，以告知异步基于网络的 TIRELESS 和研究程序的开发； 2) 进行公开试点，利用前/后测试和退出访谈来探索 Web-TIRELESS 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) 对 Web-TIRELESS 与 Web-MEUC (N=50) 进行可行性随机对照试验，以确定 1) 招募、筛选、资格、入组、随机化和评估流程的可行性，以及 2) Web-TIRELESS 和 Web-MEUC 的可行性和可接受性。研究结果将为通过 ROI 机制进行的功效试验提供信息。培训和指导：学习目标由 3 个主要培训目标支持，旨在培养以下领域的专业知识： 1）定性和混合方法研究技能（Vranceanu）； 2) 进行 01 骨科心身临床试验（Vranceanu、Ring、Chen、Ditre）； 3) 开发异步网络平台和移动医疗方法（Sylvia、Vranceanu）。多学科导师团队将监督项目的进展，并提供 1) 丰富的制度环境，2) 有针对性的课程作业、科学会议、研讨会和计划的出版物。与 NCCIH 使命的相关性：这项 K23 提案符合 NCCIH 的“整体健康研究”和“疼痛的补充和综合管理”的资助优先事项。影响：总的来说，在该奖项期间获得的经验将作为申请人独立职业生涯的基础，以启动一系列研究，重点是针对骨科和共病物质使用条件的可扩展、技术增强的身心干预措施的开发和测试。