Status:
RECRUITING
BE WELL With Migraine: Brain Education and WELLness With Migraine
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Migraine
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Detailed Description
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...
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
Key Trial Info
Start Date :
July 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
286 Patients enrolled
Trial Details
Trial ID
NCT05987592
Start Date
July 31 2024
End Date
June 30 2027
Last Update
May 29 2025
Active Locations (3)
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1
Cambridge Health Alliance - Center for Mindfulness and Compassion
Cambridge, Massachusetts, United States, 02141
2
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
3
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3039