BE WELL With Migraine: Brain Education and WELLness With Migraine

This study, called "BE WELL With Migraine," is testing two different non-drug, virtual programs to help people with migraine. Both programs, called Brain Education and WELLness with Migraine Group A and Group B, involve 8 weekly online group sessions with an instructor and access to an online platform with more learning materials. You might be able to join if you are at least 18 years old, have migraine 4-20 days a month for at least a year, and have significant headache-related disability. The study will measure how much your migraine-related disability changes after 8 weeks. This study is currently unclear about its recruitment status and aims to enroll 286 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 286 participants.
What's involved
You would participate in 8 weekly online classes, complete an initial online screen, and have a phone or video call for a baseline assessment. You will also keep an online daily headache log and complete several online surveys throughout the study.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured immediately post-intervention at 8 weeks.

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NCT05987592

BE WELL With Migraine: Brain Education and WELLness With Migraine

Recruiting
NAAges 18+InterventionalSupportive care
Wake Forest University Health Sciences
~286 participants
Updated 2026-06-12 on ClinicalTrials.gov
What's tested:Brain Education and WELLness with Migraine Group ABrain Education and WELLness with Migraine Group B

At a glance

Recruiting sites
1 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Disability assessed using monthly Migraine Disability Assessment (mMIDAS) - Change in Migraine Disability from baseline to 8 weeks
Measured over Immediately post-intervention at 8 weeks
Migraine
3 sites across 3 states
Massachusetts1
North Carolina1
Ohio1
  • Rebecca E Wells, MD, MPH · PRINCIPAL_INVESTIGATOR · Wake Forest University Health Sciences

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Eligibility criteria

Inclusion

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

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
  • Disability assessed using monthly Migraine Disability Assessment (mMIDAS) - Change in Migraine Disability from baseline to 8 weeksImmediately post-intervention at 8 weeks

    Most frequently used headache disability measure developed by Dr. Richard Lipton that captures both presenteeism and absenteeism. Although originally developed to report the prior 3 months, the monthly MIDAS ("mMIDAS") reduces recall bias and improves validity.