Virtual wellness program for migraine management
BE WELL With Migraine: Brain Education and WELLness With Migraine
NA · Wake Forest University Health Sciences · NCT05987592
This study tests two online wellness programs to see if they can help people with migraines feel better while they continue their usual medications.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 286 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences (other) |
| Locations | 3 sites (Cambridge, Massachusetts and 2 other locations) |
| Trial ID | NCT05987592 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates two non-drug virtual treatment options aimed at improving the lives of patients with migraine. Participants will engage in 8 weekly online sessions and utilize an online platform for additional resources and learning. The study allows participants to continue their current medications while they complete assessments and surveys virtually. The goal is to gather information that may enhance future migraine treatment strategies.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a diagnosis of migraine, experiencing 4-20 headache days per month.
Not a fit: Patients with major unstable medical or psychiatric conditions or those experiencing medication overuse headaches may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could provide patients with effective non-drug strategies to manage their migraines.
How similar studies have performed: Other studies have shown promise in using virtual interventions for migraine management, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Cambridge, Massachusetts and 2 other locations
- Cambridge Health Alliance - Center for Mindfulness and Compassion — Cambridge, Massachusetts, United States (NOT_YET_RECRUITING)
- Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States (RECRUITING)
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Rebecca E Wells, MD, MPH — Wake Forest University Health Sciences
- Study coordinator: Hannah O'Brien
- Email: Hannah.Obrien@Advocatehealth.org
- Phone: 336-713-5776
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Migraine, Migraine without aura, Migraine with aura, behavioral, mind-body, integrative, virtual, online