BE WELL With Migraine: Brain Education and WELLness With Migraine

Wake Forest University (WFU)

Status: Enrolling

Conditions: Migraine

Treatments: Behavioral: Brain Education and WELLness with Migraine Group B; Behavioral: Brain Education and WELLness with Migraine Group A

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05987592

R01AT011502 (U.S. NIH Grant/Contract)

IRB00079570

Details and patient eligibility

About

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.

Full 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.

Enrollment: 286 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

286 participants in 2 patient groups

Brain Education and WELLness with Migraine Group A

Experimental group

Description:

8 weekly virtual sessions plus online platform

Treatment:

Behavioral: Brain Education and WELLness with Migraine Group A

Brain Education and WELLness with Migraine Group B

Experimental group

Description:

8 weekly virtual sessions plus online platform

Treatment:

Behavioral: Brain Education and WELLness with Migraine Group B