BE WELL With Migraine: Brain Education and WELLness With Migraine

Обзор

The goal of this randomized clinical trial is to evaluate two different non-drug, virtual treatment options designed to improve the lives of patients with migraine. Both interventions involve 8 weekly sessions and an online platform with additional content and learning. Participants can stay on all their medications during this study. Information from this study may help determine how to better treat migraine.

Подробное описание

This study involves 8 weekly virtual sessions \& an online platform designed to improve the lives of patients with migraine. Participants from across the United States with migraine may be eligible to participate. This study does not require any in-person visits. All assessments and surveys will be completed virtually and/or online. Participants will independently complete an initial online screen. Participants will attend a scheduled phone or videoconferencing call with a study team member to complete the baseline assessment and learn how to use the online platform. Participants will keep an online daily headache log and complete several online surveys throughout the study.

Вмешательства

• Поведенческое Brain Education and WELLness with Migraine Group A
  Behavioral intervention that involves 8 weekly group virtual sessions with an instructor that may help improve migraine, plus access to an online platform with additional content and learning
• Поведенческое Brain Education and WELLness with Migraine Group B
  Behavioral intervention that involves 8 weekly group virtual sessions with an instructor that may help improve migraine, plus access to an online platform with additional content and learning

Первичные конечные точки

• Disability assessed using monthly Migraine Disability Assessment (mMIDAS) - Change in Migraine Disability from baseline to 8 weeks [Срок оценки: Immediately post-intervention at 8 weeks]

Вторичные конечные точки (8)

• Depression assessed using Patient Health Questionnaire (PHQ-8) Questionnaire - Change in Depression from baseline to 8 weeks [Срок оценки: Immediately post-intervention at 8 weeks]
• Pain Catastrophizing quantified using Pain Catastrophizing Scale (PCS) - Change in Pain catastrophizing from baseline to 8 weeks [Срок оценки: Immediately post-intervention at 8 weeks]
• Self-Efficacy assessed with the Headache Management Self-Efficacy Scale (HMSE) - Change in Self-efficacy from baseline to 8 weeks [Срок оценки: Immediately post-intervention at 8 weeks]
• Disability assessed using monthly Migraine Disability Assessment (mMIDAS) at 20 weeks - Change in migraine disability from baseline to 20 weeks [Срок оценки: Post-intervention at 20 weeks]
• Disability assessed using monthly Migraine Disability Assessment (mMIDAS) at 32 weeks - Change in migraine disability from baseline to 32 weeks [Срок оценки: Post-intervention at 32 weeks]
• Anxiety assessed using Generalized Anxiety Disorder-7 (GAD-7) at 8 weeks - Change in anxiety from baseline to 8 weeks [Срок оценки: Immediately post-intervention at 8 weeks]
• Quality of Life assessed using Migraine Specific Quality of Life version 2.1 (MSQL v2.1) at 8 weeks [Срок оценки: Immediately post-intervention at 8 weeks]
• Migraine frequency using the daily and 7-day recall headache log at 8 weeks - Change in migraine frequency from baseline to 8 weeks [Срок оценки: Immediately post-intervention at 8 weeks]

Критерии участия

Критерии включения

• Diagnosis of migraine with or without aura by with headache frequency of 4-20 days/month
• At least 1 year of migraine
• At least 18 years old
• Able to participate in 8 weekly online classes
• Willingness to complete baseline headache logs
• Headache-related disability (Headache Impact Test (HIT)-6) score >50
• Fluent in English
• Completion of technology onboarding with the online platform
• Pregnant women who are less than or equal to 16 weeks gestation at enrollment are allowed to participate

Критерии исключения

• Major unstable medical/psychiatric condition that could be unsafe for participants or for the group environment.
• Medication overuse headache, with migraine treatment
• Pregnant women who are more than 16 weeks gestation at enrollment
• Unstable migraine treatment at enrollment: any preventive treatment (oral or injectable medication or neuromodulatory device) started within 12 weeks OR acute treatment within 4 weeks to ensure stability
• Unwillingness to maintain stable current medication dosages for study duration
• Failure to complete baseline headache logs
• Heavy alcohol and illicit drug use
• Participation in another intervention clinical trial or one that would interfere in this study
• Experience with stress reduction training (daily meditation practice, regular use of a mindfulness app, or prior experience with MBSR)
• Any, and all other diagnoses or conditions which, in the opinion of the site investigator, would prevent the patient from being a suitable candidate for the study or interfere with the medical care needs of the study participant: COVID-positive test within 30 days of enrollment

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 3 центра

• Cambridge Health Alliance - Center for Mindfulness and Compassion — Cambridge
• Wake Forest University Health Sciences — Winston-Salem
• Cincinnati Children's Hospital Medical Center — Cincinnati

Публикации

• Wells RE, Floyd J, O'Brien H, Tamol N, Oliver C, Nelson C, Phillips J, Estave PM, Vaidya S, Moore B, Hamilton K, Adam E, O'Connell N, Moore JB, Lipton RB, Houle TT, Schuman-Olivier Z, Gardiner P, Powers SW; BE WELL with Migraine Champion Providers Network. Building a national headache medicine research network: The BE WELL with Migraine Champion Providers Network. Headache. 2026 Jan;66(1):249-261. PMID 41065019

Идентификаторы

NCT: NCT05987592 · IRB00079570 · R01AT011502

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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