Feasibility and Acceptability of Telephone-delivered MBCT for Migraine and Depression (FATE-MD)

电话传递 MBCT 治疗偏头痛和抑郁症 (FATE-MD) 的可行性和可接受性

• 批准号: 10828954
• 负责人: Elizabeth K Seng-Tamaccio
• 金额: $ 73.8万
• 依托单位: CLEVELAND CLINIC LERNER COM-CWRU
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-06-01 至 2025-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10828954
• 关键词: Abbreviations; Absenteeism at work; Address; Adherence; Area; Behavioral; Certification; Chronic; Chronic Disease; Classification; Client satisfaction; Clinical; Code; Competence; Comprehension; Data; Development; Disease; Economic Burden; Emotional; Feasibility Studies; Feedback; Future; Genetic; Goals; Guidelines; Headache; Headache Disorders; Health; Health Services Accessibility; High Prevalence; Home; Hour; Hypertension; Individual; Integrative Therapy; International; Interview; Knowledge; Length; Light; Manuals; Measures; Medical Care Costs; Mental Depression; Mental Health; Migraine; Mind-Body Intervention; National Center for Complementary and Integrative Health; Nausea; Neurobiology; New York; Occupational; Pain; Participant; Pathway interactions; Patients; Persons; Phase; Phase III Clinical Trials; Procedures; Productivity; Protocols documentation; Questionnaires; Randomized, Controlled Trials; Reporting; Research Design; Research Personnel; Site; Specific qualifier value; Standardization; Telephone; Therapeutic; Training; United States National Institutes of Health; Videoconferencing; Vomiting; acceptability and feasibility; arm; associated symptom; chronic pain; chronic painful condition; common symptom; comorbidity; depressive symptoms; design; disability; evidence base; improved; innovation; intervention delivery; migraine treatment; mindfulness based cognitive therapy; opioid therapy; pain symptom; patient engagement; phase III trial; pleasure; primary outcome; recruit; remote delivery; retention rate; social; sound; symposium; telephone based; telephone delivery; telephone session; therapy development; treatment arm; treatment as usual; video delivery

PROJECT SUMMARY Migraine is a common, painful and highly disabling disorder. Depressive symptoms are common in people with migraine and are associated with increased suffering. Despite the significant emotional, social, and economic burden of this comorbidity, no existing treatment adequately addresses both migraine disability and elevated depressive symptoms. Development of scalable and integrative treatments that address both migraine disability and comorbid depressive symptoms has been identified as a major gap in migraine treatment. Mindfulness-Based Cognitive Therapy (MBCT) is an evidence-based and standardized treatment that is an excellent candidate for reducing disability and depressive symptoms in people with migraine. Our preliminary data show that MBCT reduced migraine-related disability; however, during exit interviews, participants noted the burden of attending 8 weekly in-person sessions was a substantial barrier to accessing care. Our preliminary data suggest an abbreviated and telephone-delivered MBCT (MBCT-T) protocol is a feasible alternative to in-person treatment. However, video- based delivery (MBCT-V) may improve patient engagement. This project aims to prepare for a definitive multi-site Phase III trial of remote-delivered MBCT-T or MBCT-V or both in patients with migraine and depressive symptoms. During Study 1, we will use guidelines from the NIH’s Behavioral Change Consortium to optimize fidelity MBCT-T and MBCT-V for patients with migraine (as defined by the International Classification of Headache Disorders – 3) and depressive symptoms (as defined by empirical cut-offs on the Patient Health Questionnaire – 9). Products developed during Aim 1 will be: training protocols, facilitator treatment manuals, fidelity checklists, MBCT-T/V Adherence and Competence Scales, fidelity coding manuals. Products will be iteratively optimized using quantitative and qualitative fidelity metrics assessed at the patient-level (comprehension) and facilitator-level (corrective feedback, intervention delivery) following the delivery of one MBCT-T and one MBCT-V group led by a certified MBCT facilitator at a site in New York, NY. Also, during Study 1, a 22-hour training will be conducted for facilitators across two additional sites in the Bronx, NY and Winston-Salem, NC. During Study 2, we will conduct a multi-site pilot RCT (n=144) of MBCT-T, MBCT-V, and Enhanced Usual Care (EUC). We will evaluate fidelity, feasibility, and acceptability of each arm across three sites in patients with migraine and depressive symptoms. Pre- specified decision rules for fidelity, feasibility, acceptability, and clinical utility will determine the arms of the future phase III trial evaluating remote-delivered MBCT for migraine disability and depressive symptoms.

项目摘要 偏头痛是一种常见，痛苦且高度残疾的疾病。偏头痛患者常见抑郁症状，并且与痛苦增加有关。尽管这种合并症的情绪，社会和经济燃烧具有巨大的激动，但现有的治疗尚未适当解决偏头痛和抑郁症状升高。解决偏头痛残疾和合并性抑郁症状的可扩展和综合治疗的发展已被确定为偏头痛治疗的主要差距。基于正念的认知疗法（MBCT）是一种基于证据的标准化治疗方法，是减少偏头痛患者残疾和抑郁症状的出色候选者。我们的初步数据表明，MBCT减少了与偏头痛相关的残疾。但是，在退出访谈中，参与者指出，参加8周的面对面会议的燃烧是获得护理的重大障碍。我们的初步数据表明，缩写和电话传递的MBCT（MBCT-T）方案是实用治疗的可行替代方案。但是，基于视频的交付（MBCT-V）可以改善患者的参与度。该项目旨在为偏头痛和抑郁症状的患者进行遥控的MBCT-T或MBCT-V或MBCT-V的确定多站点III期试验。在研究1期间，我们将使用NIH行为改变联盟中的指南来优化偏头痛患者的保真度MBCT-T和MBCT-V（由头痛疾病的国际分类（3）和抑郁症状（由患者健康调查表的经验裁员所定义）（定义为3）。 AIM 1期间开发的产品将是：培训方案，促进者治疗手册，忠实清单，MBCT-T/V依从性和能力尺度，忠实编码手册。在由一个MBCT-T和一个MBCT-T和一个由认证的MBCT MBCT辅导员领导的MBCT-T和一个MBCT-V组之后，使用在患者级别（理解）和促进者级别（纠正反馈，干预措施）评估的定量和定性保真度指标上进行迭代优化。同样，在研究1期间，将在纽约州布朗克斯市和北卡罗来纳州布朗克斯市的其他两个地点进行促进者进行22小时的培训。在研究2期间，我们将进行MBCT-T，MBCT-V和增强常规护理（EUC）的多站点PILOT RCT（n = 144）。我们将评估偏头痛和抑郁症状患者的三个部位的每个手臂的保真度，可行性和可接受性。预先指定的忠诚，可行性，可接受性和临床实用性的决策规则将确定未来III期试验的武器，评估了偏远偏头痛残疾和抑郁症状的遥控MBCT。

项目成果

Optimized Acute Treatment of Migraine Is Associated With Greater Productivity in People With Migraine: Results From the Chronic Migraine Epidemiology and Outcomes (CaMEO) Study.

• DOI: 10.1097/jom.0000000000002801
• 发表时间: 2023-04-01
• 期刊: Journal of occupational and environmental medicine
• 影响因子: 3.2

A neuropsychologically based employment intervention for women with multiple sclerosis: A quasi-randomized controlled trial.

针对多发性硬化症女性的基于神经心理学的就业干预：一项准随机对照试验。

• DOI: 10.1017/s1355617722000327
• 发表时间: 2023
• 期刊: Journal of the International Neuropsychological Society : JINS
• 作者: Stimmel,MarninaB;Cohen,JennaN;Seng,ElizabethK;Shagalow,Shaina;Foley,FrederickW
• 通讯作者: Foley,FrederickW