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: 10409661
• 负责人: Elizabeth K Seng-Tamaccio
• 金额: $ 73.32万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 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 2022-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10409661
• 关键词: Address; Adherence; Area; Behavioral; 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; Work; acceptability and feasibility; arm; associated symptom; base; chronic pain; chronic painful condition; common symptom; comorbid depression; 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; telephone delivery; telephone session; telephone-based; 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.

项目概要 偏头痛是一种常见、痛苦且高度致残的疾病。抑郁症状在偏头痛患者中很常见，并且与痛苦的增加有关。尽管这种合并症带来了巨大的情感、社会和经济负担，但现有的治疗方法还没有能够充分解决偏头痛残疾和抑郁症状加重的问题。开发可扩展的综合治疗方法来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。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绝佳候选疗法。我们的初步数据表明，MBCT 减少了偏头痛相关的残疾；然而，在离职面谈期间，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一个重大障碍。我们的初步数据表明，简短的电话传递 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）可以提高患者的参与度。该项目旨在为偏头痛和抑郁症状患者进行远程 MBCT-T 或 MBCT-V 或两者的最终多中心 III 期试验做准备。在研究 1 期间，我们将使用 NIH 行为改变联盟的指南来优化偏头痛（根据头痛疾病国际分类 – 3 定义）和抑郁症状（根据患者健康问卷的经验截止值 – 9 定义）患者的 MBCT-T 和 MBCT-V 保真度。目标 1 期间开发的产品将包括：培训方案、引导者治疗手册、保真度检查表、MBCT-T/V 依从性和能力量表、保真度编码手册。在纽约州纽约市的一个地点，由经过认证的 MBCT 辅导员领导的一组 MBCT-T 和一组 MBCT-V 小组交付后，将使用在患者级别（理解）和辅导员级别（纠正反馈、干预实施）评估的定量和定性保真度指标来迭代优化产品。此外，在研究 1 期间，将为纽约州布朗克斯和北卡罗来纳州温斯顿塞勒姆另外两个地点的协调员进行 22 小时的培训。在研究 2 期间，我们将开展 MBCT-T、MBCT-V 和增强型日常护理 (EUC) 的多中心试点随机对照试验 (n=144)。我们将评估偏头痛和抑郁症状患者三个部位的每只手臂的保真度、可行性和可接受性。预先指定的保真度、可行性、可接受性和临床实用性决策规则将决定未来 III 期试验的类别，该试验评估远程传输的 MBCT 治疗偏头痛残疾和抑郁症状。