Integrative Training Program for Pediatric Sickle Cell Pain

小儿镰状细胞性疼痛综合训练计划

• 批准号: 10595974
• 负责人: Soumitri Sil
• 金额: $ 134.35万
• 依托单位: EMORY UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-19 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10595974
• 关键词: Address; Adherence; Adolescence; Adolescent; Adult; Adverse effects; Affect; African American population; Aftercare; Age; Anxiety; Behavioral; Biological Factors; Black American; Breathing; Caring; Child; Childhood; Chronic; Chronic Disease; Clinical; Clinical Practice Guideline; Clinical Trials; Cognitive; Communities; Complex; Effectiveness; Enrollment; Ensure; Family; Feedback; Fibromyalgia; Fright; Goals; Guided imagery; Health; Health Services Accessibility; Individual; Intervention; Life; Measures; Mental Depression; Methods; Mind-Body Intervention; Modeling; Movement; Multicenter Trials; Muscle relaxation phase; Outcome; Pain; Pain intensity; Pain interference; Pain management; Parents; Participant; Patients; Pharmacology; Phase; Physical activity; Population; Psychological Factors; Quality of life; Randomized; Randomized Clinical Trials; Reach Effectiveness Adoption Implementation and Maintenance; Recommendation; Research; Respiratory Diaphragm; Sampling; Sickle Cell; Sickle Cell Anemia; Site; Teenagers; Telemedicine; Testing; Time; Training; Training Programs; Waiting Lists; Work; Youth; acceptability and feasibility; arm; base; biopsychosocial factor; body-mind; chronic pain; chronic pain management; clinical implementation; comorbid depression; comorbidity; depressive symptoms; design; disability; effective therapy; effectiveness evaluation; evidence base; experience; family management; follow-up; functional disability; health disparity; health related quality of life; improved outcome; innovation; interdisciplinary treatment approach; iterative design; multi-component intervention; neuromuscular; optimal treatments; pain catastrophizing; patient engagement; preference; primary endpoint; primary outcome; programs; psychologic; racial disparity; satisfaction; secondary outcome; social factors; standard care; telehealth; therapy design

PROJECT SUMMARY Chronic pain in pediatric sickle cell disease (SCD) is a major clinical challenge due to the complex interaction of biological, psychological, and social factors. Consequently, current pharmacological and non-pharmacological treatments have variable and limited effectiveness resulting in the persistence of chronic pain during adolescence into adulthood. Optimal treatment of chronic SCD pain requires an individualized, interdisciplinary care approach that targets multifaceted biopsychosocial factors and common psychological comorbidities, such as pain-related anxiety, fear of movement, and depression, that maintain chronic pain and functional impairment. The objectives of the proposed research are to partner with patient and family stakeholders to adapt and refine an existing mind-body, cognitive-behavioral, and neuromuscular movement treatment (Fibromyalgia Integrative Training for Teens, FIT Teens) to target the unique needs and preferences of families managing chronic pain in SCD (R61 phase) and conduct a randomized clinical trial to evaluate the effectiveness of the new adapted intervention (termed I-STRONG for SCD) among youth with chronic SCD pain (R33 phase). The aims of the proposed study are to: 1) adapt and refine the FIT Teens intervention to develop a new culturally tailored I- STRONG intervention for youth with chronic SCD pain (R61 phase), 2) optimize the feasibility and acceptability of I-STRONG for SCD (R61 phase), and 3) conduct a multi-site randomized clinical trial to evaluate initial effectiveness of I-STRONG for SCD (R33 phase). We will conduct mixed method approaches to collect qualitative feedback informed by patient and family lived experiences regarding intervention content, format, perceived benefits, and barriers/facilitators to engagement with youth who have chronic SCD pain and their parents. Community stakeholder advisory boards and iterative design will inform intervention adaptation and refinement to enhance clinical implementation. We hypothesize that patients receiving I-STRONG will demonstrate significant reduction in pain interference and pain intensity (primary outcomes), and significant improvements in depressive symptoms, pain-related fear of movement, and health-related quality of life (secondary outcomes), and objectively measured physical activity (exploratory outcomes) at 3-month follow-up (primary endpoint) and 6-month follow-up. Our long-term goal is to optimize chronic SCD pain management through a multicomponent integrative approach that will be scalable for broad dissemination.

项目概要 小儿镰状细胞病 (SCD) 的慢性疼痛是一项重大的临床挑战，因为以下因素之间存在复杂的相互作用： 生物、心理和社会因素。因此，目前的药理学和非药理学 治疗效果各异且有限，导致慢性疼痛持续存在 青春期进入成年期。慢性 SCD 疼痛的最佳治疗需要个体化、跨学科的治疗 针对多方面生物心理社会因素和常见心理合并症的护理方法，例如 如与疼痛相关的焦虑、对运动的恐惧和抑郁，这些都会导致慢性疼痛和功能障碍。 拟议研究的目标是与患者和家庭利益相关者合作，以适应和完善 现有的身心、认知行为和神经肌肉运动治疗（纤维肌痛综合疗法） 针对青少年、FIT 青少年的培训，针对慢性疼痛家庭的独特需求和偏好 SCD（R61期）并进行随机临床试验，以评估新适应的有效性 对患有慢性 SCD 疼痛（R33 期）的青少年进行干预（称为 I-STRONG for SCD）。该组织的目标 拟议的研究旨在：1）调整和完善 FIT 青少年干预措施，以开发一种新的文化定制 I- 对患有慢性 SCD 疼痛（R61 期）的青少年进行强有力的干预，2) 优化可行性和可接受性 I-STRONG 治疗 SCD（R61 期），以及 3) 进行多中心随机临床试验以评估初始 I-STRONG 对 SCD（R33 期）的有效性。我们将采用混合方法来收集 由患者和家人的生活经验提供的关于干预内容、形式、 与患有慢性 SCD 疼痛及其症状的青少年接触的感知益处和障碍/促进因素 父母。社区利益相关者咨询委员会和迭代设计将为干预措施的调整和调整提供信息 细化加强临床实施。我们假设接受 I-STRONG 治疗的患者会 表现出疼痛干扰和疼痛强度（主要结果）显着减少，并且显着 改善抑郁症状、与疼痛相关的运动恐惧以及与健康相关的生活质量 （次要结果），以及 3 个月随访时客观测量的体力活动（探索性结果） （主要终点）和 6 个月随访。我们的长期目标是优化慢性 SCD 疼痛管理 通过可扩展以进行广泛传播的多组成部分综合方法。