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Набира участници Не е приложимо NCT05987592

BE WELL With Migraine: Brain Education and WELLness With Migraine

Не е приложима фаза (напр. обсервационно)
Заболявания: Migraine

Спонсор: Wake Forest University Health Sciences

Налично на: БГ
Обобщение
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.
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.
Кой може да участва
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Интервенции
Brain Education and WELLness with Migraine Group A
BEHAVIORAL
Brain Education and WELLness with Migraine Group B
BEHAVIORAL
Места на провеждане 3
САЩ (3)
Cambridge Health Alliance - Center for Mindfulness and Compassion
Cambridge , Massachusetts
NOT_YET_RECRUITING
Alexandra Comeau
Cincinnati Children's Hospital Medical Center
Cincinnati , Ohio
NOT_YET_RECRUITING
Wake Forest University Health Sciences
Winston-Salem , North Carolina
Технически детайли
Статус
Набира участници
Фаза
Не е приложимо
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
31.07.2024
Крайна дата
31.12.2027
Регистрационен номер
NCT05987592
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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