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.

项目总结

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.

偏头痛的优化急性治疗与偏头痛患者的生产率更高有关：慢性偏头痛流行病学和结果（客串）研究的结果。

• 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