BE WELL With Migraine: Brain Education and WELLness With Migraine
NCT ID: NCT05987592
Last Updated: 2025-05-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
286 participants
INTERVENTIONAL
2024-07-31
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
In addition, blinded reports will be provided to the Wake Forest Data and Safety Monitoring Board (DSMB) for safety monitoring.
Study Groups
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Brain Education and WELLness with Migraine Group A
8 weekly virtual sessions plus online platform
Brain Education and WELLness with Migraine Group A
Behavioral intervention that involves 8 weekly group virtual sessions with an instructor that may help improve migraine, plus access to an online platform with additional content and learning
Brain Education and WELLness with Migraine Group B
8 weekly virtual sessions plus online platform
Brain Education and WELLness with Migraine Group B
Behavioral intervention that involves 8 weekly group virtual sessions with an instructor that may help improve migraine, plus access to an online platform with additional content and learning
Interventions
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Brain Education and WELLness with Migraine Group A
Behavioral intervention that involves 8 weekly group virtual sessions with an instructor that may help improve migraine, plus access to an online platform with additional content and learning
Brain Education and WELLness with Migraine Group B
Behavioral intervention that involves 8 weekly group virtual sessions with an instructor that may help improve migraine, plus access to an online platform with additional content and learning
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Center for Complementary and Integrative Health (NCCIH)
NIH
Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Rebecca E Wells, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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Cambridge Health Alliance - Center for Mindfulness and Compassion
Cambridge, Massachusetts, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRB00079570
Identifier Type: -
Identifier Source: org_study_id
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