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.

项目摘要 儿童镰状细胞病（SCD）的慢性疼痛是一个主要的临床挑战，这是由于以下因素的复杂相互作用： 生理、心理和社会因素。因此，目前的药理学和非药理学 治疗具有可变的和有限的有效性， 从青春期到成年期慢性SCD疼痛的最佳治疗需要个体化、跨学科的 针对多方面生物心理社会因素和常见心理共病的护理方法， 如疼痛相关的焦虑、对运动的恐惧和抑郁，这些都维持着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 一种现有的身心、认知行为和神经肌肉运动治疗（纤维肌痛综合治疗）， 培训青少年，适合青少年），以针对家庭管理慢性疼痛的独特需求和偏好， SCD（R61期），并进行随机临床试验，以评估新适应症的有效性 在患有慢性SCD疼痛（R33期）的年轻人中进行干预（称为SCD的I-STRONG）。的目标 拟议的研究是：1）调整和完善FIT青少年干预，以开发一个新的文化定制的I- 对患有慢性SCD疼痛（R61期）的青少年进行强干预，2）优化可行性和可接受性 用于SCD的I-STRONG（R61阶段），以及3）进行多中心随机临床试验以评估初始 I-STRONG对SCD（R33阶段）的有效性。我们将采用混合方法收集 由患者和家庭生活经验提供的关于干预内容，形式， 感知的益处，以及与患有慢性SCD疼痛的青少年及其 父母社区利益攸关方咨询委员会和迭代设计将为干预措施的适应提供信息， 完善，以加强临床实施。我们假设接受I-STRONG的患者将 显示疼痛干扰和疼痛强度显着减少（主要结局），并且显着 改善抑郁症状、疼痛相关的运动恐惧和健康相关的生活质量 （次要结局）和3个月随访时客观测量的体力活动（探索性结局） （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 通过一个多成分的综合方法，将可扩展的广泛传播。