Efficacy of a Single-Session Telehealth-Based Behavioral Intervention for Chronic Migraines

摘要 目前K23项目的总体目标是支持约翰·斯特金博士作为临床医生的职业发展 研究慢性偏头痛人群；具体的培训目标是扩大他在临床领域的培训 试验设计和开发，偏头痛的医学和神经学基础，以及时间- 系列、分级和临床试验数据。偏头痛是世界上最常见的疾病之一 并造成大量的工作损失、经济负担和社会心理残疾。令人惊讶的是， 慢性偏头痛(CM)患者表现出更严重的症状、残疾和更差的心理社会 与那些患有发作性偏头痛的人相比，他们在研究中适应了自己的病情。有效治疗儿童精神分裂症 CM需要跨学科的方法，强调医疗和非医疗干预，以 解决这一人群中的残疾和心理社会障碍的复杂模式。行为 认知行为疗法和正念冥想等干预措施已证明对 减少偏头痛的频率、严重程度和残疾。然而，获得这些治疗的机会很少，尤其是 在没有通过专门诊所接受护理的个人中。此外，许多患者无法负担这两项费用 与传统行为干预相关的财务或时间成本，这通常需要每周一次 疗程2-3个月。因此，迫切需要利用开发简明、可访问和 经验验证的干预措施，以提高全国范围内的CM管理质量。研究的目标1 建议进行一项随机试验，以测试一种新的、为期2小时的单次行为干预的有效性 (“授权救济”；急诊室)针对CM患者的健康教育条件。这项研究的目标2提出 检查偏头痛活动的动态，偏头痛相关的残疾，药物使用，以及 使用日常日记数据进行心理调整，这是CM管理中常见的一种评估方法 并且对于全面的统计建模是可取的。ER干预已在两种混合慢性疾病中得到验证 疼痛和慢性下腰痛样本，但到目前为止，尚未在偏头痛人群中得到验证。如果成功， 目前的项目将构成未来随机临床试验的基础，比较两种药物的潜在非劣势 ER干预与传统的、完整的CM行为干预相比较。 K23项目中的具体培训经验是对斯特金博士现有培训的极好补充 作为一名临床疼痛心理学家和注重分析的慢性疼痛研究人员。当前项目提供了一个 全面的五年计划，包括高质量的指导、培训和研究，以过渡斯特金博士， 独立资助研究人员的作用，有可能在以下领域产生重大影响 偏头痛治疗和行为临床试验。

Abstract The overall goal of the current K23 project is to support Dr. John Sturgeon’s career development as a clinical researcher in chronic migraine populations; specific training aims are to expand his training in the areas of clinical trial design and development, medical and neurological bases of migraine headaches, and the analysis of time- series, hierarchical, and clinical trials data. Migraines are among the most common medical conditions in the United States and contribute to substantial work loss, economic burden, and psychosocial disability. Strikingly, people with chronic migraines (CM) show even greater symptom severity, disability and poorer psychosocial adjustment to their condition across studies, compared to those with episodic migraine. Effective treatment of CM necessitates an interdisciplinary approach that emphasizes both medical and non-medical interventions to address the complex pattern of disability and psychosocial impairment in this population. Behavioral interventions such as cognitive-behavioral therapy and mindfulness meditation have demonstrated efficacy in reducing migraine frequency, severity, and disability. However, access to these treatments is poor, particularly among individuals not receiving care through specialty clinics. Further, many patients are unable to afford either the financial or time costs associated with traditional behavioral interventions, which typically necessitate weekly sessions for 2-3 months. Consequently, there is a compelling need to utilize develop brief, accessible, and empirically validated interventions to improve the quality of CM management nationwide. Aim 1 of the study proposes to conduct a randomized trial to test the efficacy of a novel, 2-hour single-session behavioral intervention (“Empowered Relief”; ER) against a health education condition in individuals with CM. Aim 2 of the study proposes to examine the dynamics of migraine activity, migraine-related disability, medication use, and indicators of psychological adjustment using daily diary data, an assessment method that is both common in CM management and desirable for comprehensive statistical modeling. The ER intervention has been validated in both mixed chronic pain and chronic low back pain samples but, to date, has not been validated in migraine populations. If successful, the current project will form the basis of a future randomized clinical trial comparing the potential non-inferiority of the ER intervention against traditional, full-length behavioral interventions for CM. The specific training experiences in this K23 project form an excellent complement to Dr. Sturgeon’s existing training as a clinical pain psychologist and analytically-oriented chronic pain researcher. The current project provides a comprehensive 5-year plan encompassing high-quality mentorship, training, and research to transition Dr. Sturgeon, to the role of an independently funded researcher with the potential to make a significant impact in the field of migraine treatment and behavioral clinical trials.