Mind Body Balance for Pediatric Migraine

项目摘要 心理和身体方法，特别是横隔式呼吸，渐进式肌肉放松，有指导 图像和生物反馈可以改善患有慢性疼痛的儿童和青少年的预后。一种流行的 慢性疼痛的原因是偏头痛。在世界范围内，它是第二大致残神经疾病。当年轻人学习的时候 并练习精神和身体技能，头痛天数和相关残疾减少。通常， 试验测试了由心理学家教授的非药物干预方案，在面对面的会议上， 每周超过4到8次会议。虽然很有效，但这种模式对大多数家庭来说是不可用的，因为 缺乏训练有素的提供者，距离和旅行障碍，以及对会议的时间投入。我们最新的试飞 研究(利益相关者参与和卫生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、引导意象和 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。此外，护士在 头痛中心报告说，他们会感到舒服，并有兴趣学习如何介绍 这些技能给患者；儿科头痛专家和初级保健提供者正在寻找有效的 以及向他们的病人介绍精神和身体技能的有效方法。因此，我们需要进行务实的试验 在典型医疗保健的背景下测试这些综合方法的交付情况，以确认它们是否 能不能提供好处。但是，尽管有证据表明它是安全的、有效的和成功的先前试验执行，它是 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 在实施多点有效性试验之前，对结果的改变至关重要。在NCCIH U01中，我们 将优化偏头痛预防治疗方案，重点放在将提供的4项心理和身体技能 由两个门诊头痛中心(辛辛那提和丹佛)的医疗保健提供者(对于这个项目，护士)。一个 创新的干预细化方法--多阶段优化策略(MOST) (将使用https://methodology.psu.edu/ra/most)来确定必要的成分和剂量 高效、有效的治疗，然后可以对照标准护理进行测试(无需任何技能的患者教育 ≥ 培训)通过务实的试验。在这个析因实验中，我们将招募200名年龄在10到17岁之间的青年 诊断为偏头痛，每月头痛4天(每8种情况下N=25)。 将测试三个部分：与护士进行技能介绍的会议时间(20或40分钟)； 每天在家中练习8周的技能(使用简单的讲义方法或使用主动的、有指导的电子健康 申请)；以及遵守提示电话在1个月(通话或不通话的剂量)。终点是令人头痛的 天数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；和功能残疾)。这三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MOST方法确定。

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.