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

基于单次远程医疗的行为干预对慢性偏头痛的疗效

基本信息

批准号：
10540238
负责人：
John Andrew Sturgeon
金额：
$ 18.9万
依托单位：
UNIVERSITY OF MICHIGAN AT ANN ARBOR
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-12-15 至 2026-11-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10540238
关键词：
Absenteeism at work Address Aftercare Analgesics Anxiety Area Behavior Behavior Therapy Behavioral Caring Chronic Chronic low back pain Clinic Clinical Clinical Trials Clinical Trials Design Cognitive Cognitive Therapy Complement Complex Data Development Economic Burden Evidence based treatment Expenditure Frequencies Funding Future Goals Health Services Accessibility Health education Hour Impairment Improve Access Individual Intervention Length Low Back Pain Low income Measures Mediating Medical Meditation Mental Depression Mentorship Methodology Methods Migraine Neurologic Neurosciences Outcome Pain Pain intensity Pain management Patients Pattern Persons Pharmaceutical Preparations Population Populations at Risk Protocols documentation Psychological Factors Psychological adjustment Psychologist Public Health Randomized Reporting Research Research Personnel Resources Retrospective Studies Risk Role Sampling Self Management Severities Sleep disturbances Source Statistical Models Symptoms Testing Time Time Series Analysis Training United States United States National Institutes of Health Woman Work arm base behavioral clinical trial behavioral response biopsychosocial cancer surgery career development chronic pain clinical pain comparative efficacy cost diaries digital disability effective therapy efficacy testing efficacy trial empowerment evidence base experience follow-up improved interdisciplinary approach intervention effect malignant breast neoplasm medical specialties migraine treatment mindfulness meditation novel opioid use pain catastrophizing pain reduction pharmacologic primary endpoint primary outcome psychological distress psychosocial psychosocial adjustment randomized trial randomized, clinical trials remote delivery response secondary endpoint secondary outcome skills statistics telehealth treatment trial trial comparing

项目摘要

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.

抽象的当前 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员；具体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是最常见的医疗状况之一。令人震惊的是，美国造成了大量的工作损失、经济负担和社会心理残疾。患有慢性偏头痛 (CM) 的人表现出更严重的症状、残疾和更差的社会心理与间歇性偏头痛患者相比，通过研究调整他们的病情。 CM 需要采用跨学科方法，强调医学和非医学干预措施解决该人群中复杂的残疾和社会心理障碍模式。认知行为疗法和正念冥想等干预措施已被证明有效减少偏头痛的频率、严重程度和残疾然而，获得这些治疗的机会却很少。此外，许多患者也无力承担任何费用。与传统行为干预相关的财务或时间成本，通常需要每周进行一次经过 2-3 个月的会议审查，迫切需要利用简短、易于理解的内容。旨在提高全国 CM 管理质量的经实证验证的干预措施。提议进行一项随机试验来测试一种新颖的 2 小时单次行为干预的功效（“Empowered Relief”；ER）针对 CM 患者的健康教育状况。检查偏头痛活动的动态、偏头痛相关的残疾、药物使用以及偏头痛指标使用日常日记数据进行心理调整，这是CM管理中常见的评估方法 ER 干预已在混合慢性病中得到验证。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。当前的项目将构成未来随机临床试验的基础，比较潜在的非劣效性 ER 干预与传统的、完整的 CM 行为干预相比。此次K23项目的具体培训经验对Sturgeon博士现有的培训形成了极好的补充作为一名临床疼痛心理学家和以分析为导向的慢性疼痛研究人员，当前的项目提供了一个。全面的 5 年规划，包括高质量的指导、培训和研究，以实现 Sturgeon 博士的过渡，独立资助的研究人员的角色，有可能在该领域产生重大影响偏头痛治疗和行为临床试验。