Recruiting

Brain Education

Sponsor:

Wake Forest University Health Sciences

Code:

NCT05987592

Conditions

Migraine

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Brain Education and WELLness with Migraine Group A

Brain Education and WELLness with Migraine Group B

Study Details

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.

Conditions

Migraine

Study ID

NCT05987592

Start date

Jul 31, 2024

Status verified date

Apr, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

286 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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

Interventions

Brain Education and WELLness with Migraine Group A

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

Brain Education and WELLness with Migraine Group B

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

Primary outcome measure

  • Disability assessed using monthly Migraine Disability Assessment (mMIDAS) - Change in Migraine Disability from baseline to 8 weeks [ Time Frame: Immediately post-intervention at 8 weeks ]

Central Contacts and Locations

Central contacts

Nicole Tamol

336-978-1362Help4Migraine@wfusm.edu

Locations

Wake Forest University Health Sciences

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Nicole Tamol

336-978-1362Help4Migraine@wfusm.edu

Principal Investigator:

Rebecca E Wells, MD, MPH

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Jun 12, 2026

Last verified

Apr, 2026

Keywords

  • Migraine
  • Migraine without aura
  • Migraine with aura
  • behavioral
  • mind-body
  • integrative
  • virtual
  • online

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-06-12.