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博士作为临床的职业发展慢性偏头痛人群的研究人员；具体的培训目的是扩大他在临床领域的培训试验设计和开发，偏头痛标题的医学和神经系统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状况之一美国，并促进大量工作损失，经济伯恩和社会心理残疾。令人惊讶的是，患有慢性偏头痛（CM）的人表现出更大的症状严重程度，残疾和较差的社会心理与偏头痛的偏头痛相比，对整个研究的状况进行了调整。有效治疗 CM有必要的跨学科方法，该方法强调医学和非医学干预措施解决该人群中残疾和社会心理障碍的复杂模式。行为诸如认知行为疗法和正念冥想之类的干预措施已经表现出效率降低偏头痛的频率，严重性和残疾。但是，获得这些治疗的机会很差，尤其是在不通过专科诊所接受护理的个人中。此外，许多患者也无法负担传统行为干预措施相关的财务或时间成本，通常每周必要会议2-3个月。因此，有迫切需要开发简短，可访问和经验验证的干预措施，以提高全国CM管理的质量。目标1 提议进行随机试验以测试新型的2小时单程行为干预的效率（“授权救济”; er）反对有商业广告的人的健康教育条件。目标2的目标提案检查偏头痛活动的动态，偏头痛相关的残疾，药物使用和指标使用每日日记数据的心理调整，这是CM管理中常见的评估方法并且需要全面的统计建模。 ER干预措施均已在两种混合慢性中验证疼痛和慢性下背部疼痛样本，但迄今为止尚未在偏头痛人群中得到验证。如果成功，当前项目将构成将来的随机临床试验的基础，比较针对传统的全长行为干预措施的ER干预措施。这个K23项目中的特定培训经验构成了Sturgeon博士现有培训的绝佳完成作为临床疼痛心理学家和以分析为导向的慢性疼痛研究者。当前项目提供了全面的5年计划包括高质量的心态，培训和研究，以过渡到斯特金博士，扮演一个独立资助的研究人员，有可能对领域产生重大影响偏头痛治疗和行为临床试验。