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

项目摘要 偏头痛是一种常见的，痛苦的和高度致残的疾病。抑郁症状在偏头痛患者中很常见，并与痛苦增加有关。尽管这种合并症有显著的情感、社会和经济负担，但现有的治疗方法不能充分解决偏头痛残疾和抑郁症状升高。开发可扩展的综合治疗方法，解决偏头痛残疾和共病抑郁症状，已被确定为偏头痛治疗的主要差距。正念认知疗法（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绝佳选择。我们的初步数据显示，MBCT减少了偏头痛相关的残疾;然而，在离职面谈中，参与者指出，参加每周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，一个简短的和电话传递的MBCT（MBCT-T）协议是一个可行的替代亲自治疗。然而，基于视频的递送（MBCT-V）可以改善患者参与。该项目旨在为在偏头痛和抑郁症状患者中进行远程递送MBCT-T或MBCT-V或两者的确定性多中心III期试验做准备。在研究1中，我们将使用NIH行为改变联盟的指南来优化偏头痛患者（根据头痛疾病国际分类-3定义）和抑郁症状（根据患者健康问卷-9的经验截止值定义）的MBCT-T和MBCT-V的保真度。在目标1期间开发的产品将是：培训协议，辅导员治疗手册，保真度检查表，MBCT-T/V依从性和能力量表，保真度编码手册。产品将使用定量和定性保真度指标进行迭代优化，这些指标是在纽约的一个研究中心由一名经过认证的MBCT促进者领导的一个MBCT-T和一个MBCT-V组交付后，在患者水平（理解）和促进者水平（纠正反馈、干预交付）进行评估的。此外，在研究1期间，将对布朗克斯，NY和温斯顿-塞勒姆，NC的另外两个研究中心的协调员进行22小时培训。在研究2期间，我们将进行一项MBCT-T、MBCT-V和增强型精神病护理（EUC）的多中心试点RCT（n = 144）。我们将在偏头痛和抑郁症状患者的三个部位评估每组的保真度、可行性和可接受性。预先规定的决定规则的保真度，可行性，可接受性，和临床效用将确定武器的未来III期试验评估远程交付MBCT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.