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

摘要 当前K23项目的总体目标是支持John Sturgeon博士作为临床医生的职业发展 慢性偏头痛人群的研究人员;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，以及时间分析- 系列、分层和临床试验数据。偏头痛是最常见的医疗条件， 美国和促成大量的工作损失，经济负担和心理残疾。引人注目的是， 患有慢性偏头痛（CM）的人表现出更严重的症状，残疾和更差的心理社会 与发作性偏头痛患者相比，有效治疗 CM需要一种跨学科的方法，强调医学和非医学干预， 解决这一人群中复杂的残疾和社会心理障碍问题。行为 认知行为疗法和正念冥想等干预措施已经证明了对 降低偏头痛的频率、严重程度和残疾。然而，获得这些治疗的机会很少，特别是 在没有通过专科诊所接受治疗的个人中。此外，许多患者无法负担 与传统行为干预相关的财务或时间成本，通常需要每周 2-3个月的会议。因此，迫切需要利用开发简短，可访问， 经验验证的干预措施，以提高全国CM管理的质量。研究目的1 建议进行一项随机试验，以测试一种新颖的，2小时的单次行为干预的有效性 （“授权救济”; ER）对CM患者的健康教育状况。研究目标2提出 检查偏头痛活动的动力学，偏头痛相关的残疾，药物使用，以及 使用每日日记数据进行心理调整，这是一种在CM管理中常见的评估方法， 并且期望用于综合统计建模。ER干预已在混合性慢性 疼痛和慢性腰痛样本，但迄今为止，尚未在偏头痛人群中得到验证。如果成功， 目前的项目将形成未来随机临床试验的基础， ER干预与传统的CM全长行为干预的对比。 K23项目中的具体培训经验是对Sturgeon博士现有培训的极好补充 作为一个临床疼痛心理学家和分析导向的慢性疼痛研究者。目前的项目提供了一个 全面的5年计划，包括高质量的指导，培训和研究，以过渡博士斯特金， 作为一名独立资助的研究人员，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.