BE WELL With Migraine: Brain Education and WELLness With Migraine (NCT05987592) | Clinical Trial Compass
RecruitingNot Applicable
BE WELL With Migraine: Brain Education and WELLness With Migraine
United States286 participantsStarted 2024-07-31
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Disability assessed using monthly Migraine Disability Assessment (mMIDAS) - Change in Migraine Disability from baseline to 8 weeks
Timeframe: Immediately post-intervention at 8 weeks