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Mind Body Balance for Pediatric Migraine

小儿偏头痛的身心平衡

基本信息

批准号：
10646251
负责人：
SCOTT W POWERS
金额：
$ 82.08万
依托单位：
CINCINNATI CHILDRENS HOSP MED CTR
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-06-01 至 2025-05-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10646251
关键词：
Adherence Adolescent Age Anxiety Biofeedback Breathing Caring Child Childhood Clinical Clinical Trials Complex Coping Skills Diagnosis Disease Dose Dropout Educational process of instructing Enrollment Equilibrium Family Feasibility Studies Guided imagery Headache Health Personnel Home Hour Imagery Intervention Learning Measures Medical Mental Depression Methodology Migraine Modeling Muscle relaxation phase National Center for Complementary and Integrative Health Nurses Nursing Staff Outcome Outpatients Participant Patient Education Patients Pediatric Nursing Pilot Projects Prevention Protocols documentation Provider Psychologist Registered nurse Reporting Research Research Design Resources Respiratory Diaphragm Safety Site Sleep Specialist Telephone Testing Time Training Travel United States Visit Youth care delivery chronic pain design diaries disability eHealth effective therapy effectiveness trial exceptional responders experience experimental group experimental study follow-up functional disability improved improved outcome innovation interest intervention delivery intervention refinement meetings mind/body multiphase optimization strategy nervous system disorder pragmatic trial primary care provider progressive relaxation therapy psychologic resource guides secondary endpoint skills skills training standard care training project treatment duration treatment optimization

项目摘要

Project Summary Mind and body approaches, specifically diaphragmatic breathing, progressive muscle relaxation, guided imagery, and biofeedback, improve outcomes for children and adolescents with chronic pain. One prevalent cause of chronic pain is migraine. Worldwide, it is the 2nd most disabling neurological disease. When youth learn and practice mind and body skills, the number of headache days and associated disability are reduced. Typically, trials have tested non-pharmacological intervention packages taught by psychologists, in face-to-face sessions, occurring over 4 to 8 weekly meetings. While efficacious, this model is not accessible to most families because of lack of trained providers, distance and travel barriers, and time commitment to sessions. Our recent pilot studies (both stakeholder engagement and health care provider skills training projects) show that youth who receive outpatient psychological care report that learning breathing, muscle relaxation, guided imagery, and biofeedback are the most useful and impactful components of the larger treatment package. Also, nurses in headache centers report that they would feel comfortable with and are interested in learning how to introduce these skills to patients; and pediatric headache specialists and primary care providers are searching for efficient and effective ways to introduce mind and body skills to their patients. Thus, we need to conduct pragmatic trials to test the delivery of these integrated approaches within the context of typical medical care to confirm if they can provide benefit or not. But, despite evidence of safety, efficacy, and successful prior trial execution, it is necessary to optimize a treatment package by evaluating which components and doses of a complex intervention are critical for changes in outcomes prior to implementing a multi-site effectiveness trial. In this NCCIH U01, we will optimize a migraine prevention treatment package focused on 4 mind and body skills that will be delivered by health care providers (for this project, nurses) in two outpatient headache centers (Cincinnati & Denver). An innovative intervention refinement approach, The Multiphase Optimization Strategy (MOST) (https://methodology.psu.edu/ra/most) will be employed to determine necessary components and doses of an efficient, effective treatment that can then be tested against standard care (patient education without any skills ≥ training) via a pragmatic trial. For this factorial experiment, we will enroll 200 youth ages 10 to 17 years with a diagnosis of migraine who are experiencing 4 headache days per month (N = 25 per each of 8 conditions). Three components will be tested: session time with nurses for introduction to the skills (dose of 20 or 40 minutes); daily home practice of skills for 8 weeks (dose of a simple handout approach or use of an active, guided eHealth application); and adherence prompt phone call at 1-month (dose of a call or no call). The endpoints are headache days and migraine-related disability (plus treatment fidelity, feasibility, drop-out rates, acceptance, & credibility; sleep; depression; anxiety; and functional disability). The most efficient combination of doses of the 3 components will be determined using the MOST approach, guided by the resource management and the optimization principles.

项目摘要精神和身体的方法，特别是呼吸，渐进式肌肉放松，指导图像和生物反馈，改善儿童和青少年慢性疼痛的结果。一种流行的慢性疼痛的原因是偏头痛。在世界范围内，它是第二大致残性神经系统疾病。当年轻人学会并练习身心技能，头痛天数和相关残疾就会减少。典型地，试验已经测试了由心理学家教授的非药物干预包，在面对面的会议上，每周举行4至8次会议。虽然有效，但这种模式对大多数家庭来说并不容易，因为缺乏训练有素的提供者，距离和旅行障碍，以及对会议的时间承诺。我们最近的飞行员研究（利益攸关方参与和保健提供者技能培训项目）表明，接受门诊心理护理报告，学习呼吸，肌肉放松，引导图像，和生物反馈是更大的治疗方案中最有用和最有影响力的组成部分。护士在头痛中心报告说，他们会感到舒适，并有兴趣学习如何介绍儿童头痛专家和初级保健提供者正在寻找有效的以及向病人介绍身心技能的有效方法。因此，我们需要进行务实的审判在典型的医疗护理背景下测试这些综合方法的交付，以确认它们是否能不能带来好处。但是，尽管有安全性、有效性和成功的前期试验执行的证据，有必要通过评估复杂干预的哪些成分和剂量来优化治疗方案在实施多中心有效性试验之前，对结局的变化至关重要。在这个NCCIH U 01中，我们将优化偏头痛预防治疗包，重点是4个身心技能，将提供由两个门诊头痛中心（辛辛那提和丹佛）的卫生保健提供者（对于本项目，护士）进行。一个多阶段优化策略（MOST）（https：//methodology.psu.edu/ra/most）将用于确定治疗的必要组分和剂量。有效的治疗，然后可以测试标准护理（没有任何技能的患者教育） ≥ 通过务实的尝试。在这个析因实验中，我们将招募200名10至17岁的青少年，诊断为每月经历4个头痛日的偏头痛患者（8种病症中每种N = 25）。将测试三个组成部分：与护士介绍技能的会话时间（20或40分钟的剂量）; 8周的日常家庭技能练习（简单的讲义方法或使用积极的指导性电子健康应用）;以及1个月时的依从性提示电话（电话剂量或无电话）。终点是头痛天和偏头痛相关的残疾（加上治疗的保真度，可行性，辍学率，接受度和可信度; 睡眠、抑郁、焦虑和功能性残疾）。3种成分的最有效剂量组合将在资源管理和优化原则的指导下，采用社会变革管理计划的方法来确定。