BE WELL With Migraine: Brain Education and WELLness With Migraine
2 other identifiers
interventional
286
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2024
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 4, 2023
CompletedFirst Posted
Study publicly available on registry
August 14, 2023
CompletedStudy Start
First participant enrolled
July 31, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
April 29, 2026
April 1, 2026
2.9 years
August 4, 2023
April 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disability assessed using monthly Migraine Disability Assessment (mMIDAS) - Change in Migraine Disability from baseline to 8 weeks
Most frequently used headache disability measure developed by Dr. Richard Lipton that captures both presenteeism and absenteeism. Although originally developed to report the prior 3 months, the monthly MIDAS ("mMIDAS") reduces recall bias and improves validity.
Immediately post-intervention at 8 weeks
Secondary Outcomes (8)
Depression assessed using Patient Health Questionnaire (PHQ-8) Questionnaire - Change in Depression from baseline to 8 weeks
Immediately post-intervention at 8 weeks
Pain Catastrophizing quantified using Pain Catastrophizing Scale (PCS) - Change in Pain catastrophizing from baseline to 8 weeks
Immediately post-intervention at 8 weeks
Self-Efficacy assessed with the Headache Management Self-Efficacy Scale (HMSE) - Change in Self-efficacy from baseline to 8 weeks
Immediately post-intervention at 8 weeks
Disability assessed using monthly Migraine Disability Assessment (mMIDAS) at 20 weeks - Change in migraine disability from baseline to 20 weeks
Post-intervention at 20 weeks
Disability assessed using monthly Migraine Disability Assessment (mMIDAS) at 32 weeks - Change in migraine disability from baseline to 32 weeks
Post-intervention at 32 weeks
- +3 more secondary outcomes
Study Arms (2)
Brain Education and WELLness with Migraine Group A
EXPERIMENTAL8 weekly virtual sessions plus online platform
Brain Education and WELLness with Migraine Group B
EXPERIMENTAL8 weekly virtual sessions plus online platform
Interventions
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
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Cambridge Health Alliance - Center for Mindfulness and Compassion
Cambridge, Massachusetts, 02141, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039, United States
Related Publications (1)
Wells RE, Floyd J, O'Brien H, Tamol N, Oliver C, Nelson C, Phillips J, Estave PM, Vaidya S, Moore B, Hamilton K, Adam E, O'Connell N, Moore JB, Lipton RB, Houle TT, Schuman-Olivier Z, Gardiner P, Powers SW; BE WELL with Migraine Champion Providers Network. Building a national headache medicine research network: The BE WELL with Migraine Champion Providers Network. Headache. 2026 Jan;66(1):249-261. doi: 10.1111/head.15065. Epub 2025 Oct 9.
PMID: 41065019DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rebecca E Wells, MD, MPH
Wake Forest University Health Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2023
First Posted
August 14, 2023
Study Start
July 31, 2024
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
April 29, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- After publication and within 12 months of completion of the analysis of study primary aims and ending within 36 months, anonymous and de-identified data will be made available on clinicaltrials.gov so that other investigators can verify or follow-up on the reported analyses.
- Access Criteria
- Investigators whose proposed use of the data has been approved by an IRB identified for this purpose - For individual participant data meta-analysis - Data will be made available on clinicaltrials.gov
De-identified data related to our outcome measures will be included in the IPD Sharing Statement (IPD) sharing plan, in addition to our study protocol, informed consent, and analytic plan.