BE WELL With Migraine: Brain Education and WELLness With Migraine
Purpose
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.
Condition
- Migraine
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Two-arm parallel assignment in which one group receives treatment A and the other group receives treatment B
- Primary Purpose
- Supportive Care
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- The study PI, statistician, co-investigators, and all personnel who are involved in endpoint assessments, will be blinded. In addition, blinded reports will be provided to the Wake Forest Data and Safety Monitoring Board (DSMB) for safety monitoring.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Brain Education and WELLness with Migraine Group A |
8 weekly virtual sessions plus online platform |
|
|
Experimental Brain Education and WELLness with Migraine Group B |
8 weekly virtual sessions plus online platform |
|
Recruiting Locations
Winston-Salem, North Carolina 27157
More Details
- Status
- Recruiting
- Sponsor
- Wake Forest University Health Sciences
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 participate. This study does not require any in-person visits. All assessments and surveys will be completed virtually and/or online. Participants will independently complete an initial online screen. Participants will attend a scheduled phone or videoconferencing call with a study team member to complete the baseline assessment and learn how to use the online platform. Participants will keep an online daily headache log and complete several online surveys throughout the study.