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

项目总结 偏头痛是一种常见的、痛苦的、高度致残的疾病。抑郁症状在偏头痛患者中很常见，并与更多的痛苦有关。尽管这种共病带来了巨大的情感、社会和经济负担，但目前还没有一种治疗方法能充分解决偏头痛残疾和抑郁症状升高的问题。发展可扩展和综合的治疗方法，同时解决偏头痛残疾和共病抑郁症状，已被认为是偏头痛治疗的主要差距。基于正念的认知疗法(MBCT)是一种循证和标准化的治疗方法，是减少偏头痛患者残疾和抑郁症状的极佳候选方案。我们的初步数据显示，MBCT减少了偏头痛相关的残疾；然而，在离职访谈中，参与者注意到每周参加8次面对面会议的负担是获得护理的重大障碍。我们的初步数据表明，简化的电话传递MBCT(MBCT-T)方案是面对面治疗的可行替代方案。然而，基于视频的交付(MBCT-V)可能会提高患者的参与度。该项目旨在为一项最终的多点第三阶段试验做准备，远程输送MBCT-T和/或MBCT-V用于有偏头痛和抑郁症状的患者。在第一项研究中，我们将使用美国国立卫生研究院行为改变联盟的指导方针来优化偏头痛患者(根据国际头痛疾病分类-3)和抑郁症状患者(根据患者健康问卷-9的经验截止值定义)的MBCT-T和MBCT-V保真度。在目标1期间开发的产品将是：培训方案、促进者治疗手册、保真度检查表、MBCT-T/V遵从性和能力量表、保真度编码手册。在纽约州纽约的一个地点交付一个MBCT-T和一个MBCT-V小组后，将使用在患者层面(理解)和促进者层面(纠正反馈、干预交付)评估的定量和定性保真度指标反复优化产品。此外，在研究1期间，将在纽约布朗克斯和北卡罗来纳州温斯顿-塞勒姆的另外两个地点为主持人进行22小时的培训。在研究2期间，我们将进行MBCT-T、MBCT-V和增强型日常护理(EUC)的多点试点随机对照试验(n=144)。我们将评估在有偏头痛和抑郁症状的患者中，每个手臂跨越三个部位的保真度、可行性和可接受性。关于保真度、可行性、可接受性和临床实用性的预先指定的决策规则将决定未来第三阶段试验的武器，该试验评估远程交付的MBCT治疗偏头痛残疾和抑郁症状。

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.