NCT05987592 BE WELL With Migraine: Brain Education and WELLness With Migraine
| NCT ID | NCT05987592 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Wake Forest University Health Sciences |
| Condition | Migraine |
| Study Type | INTERVENTIONAL |
| Enrollment | 286 participants |
| Start Date | 2024-07-31 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 286 participants in total. It began in 2024-07-31 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Rebecca E Wells, MD, MPH
PRINCIPAL INVESTIGATOR
Wake Forest University Health Sciences
Frequently Asked Questions
Who can join the NCT05987592 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Migraine. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05987592 currently recruiting?
Yes, NCT05987592 is actively recruiting participants. Contact the research team at Help4Migraine@wfusm.edu for enrollment information.
Where is the NCT05987592 trial being conducted?
This trial is being conducted at Cambridge, United States, Winston-Salem, United States, Cincinnati, United States.
Who is sponsoring the NCT05987592 clinical trial?
NCT05987592 is sponsored by Wake Forest University Health Sciences. The principal investigator is Rebecca E Wells, MD, MPH at Wake Forest University Health Sciences. The trial plans to enroll 286 participants.
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