NCT05987592Recruiting
BE WELL With Migraine: Brain Education and WELLness With Migraine
Source: ClinicalTrials.gov · Last updated 12 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 286 (estimated)
- First submitted
- 4 Aug 2023
- Start date
- 31 Jul 2024
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Wake Forest University Health Sciences
- Diseases
- Migraine
- NCT number
- NCT05987592
What you commit to
- Study type: Interventional
- Planned participants: 286
- From 31 Jul 2024 to the primary completion date, 30 Jun 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Medication overuse headache, with migraine treatment
- 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
- Heavy alcohol and illicit drug use
- Experience with stress reduction training (daily meditation practice, regular use of a mindfulness app, or prior experience with MBSR)
Other illness
- Major unstable medical/psychiatric condition that could be unsafe for participants or for the group environment.
- Failure to complete baseline headache logs
- 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
Other
- Pregnant women who are more than 16 weeks gestation at enrollment
- Participation in another intervention clinical trial or one that would interfere in this study
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cambridge Health Alliance - Center for Mindfulness and Compassion Coordinator of this site? Confirm its status | Cambridge | United States | Not yet recruiting |
| Cincinnati Children's Hospital Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Not yet recruiting |
| Wake Forest University Health Sciences Coordinator of this site? Confirm its status | Winston-Salem | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.