BE WELL With Migraine: Brain Education and WELLness With Migraine

June 11, 2026 updated by: Wake Forest University Health Sciences
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
286

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Massachusetts
      • Cambridge, Massachusetts, United States, 02141
        • Not yet recruiting
        • Cambridge Health Alliance - Center for Mindfulness and Compassion
        • Contact:
        • Sub-Investigator:
          • Paula Gardner, MD, MPH
        • Sub-Investigator:
          • Zev Schuman-Oliver, MD
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest University Health Sciences
        • Principal Investigator:
          • Rebecca E Wells, MD, MPH
        • Contact:
    • Ohio
      • Cincinnati, Ohio, United States, 45229-3039
        • Not yet recruiting
        • Cincinnati Children's Hospital Medical Center
        • Contact:
        • Principal Investigator:
          • Scott Powers, PhD, ABPP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Brain Education and WELLness with Migraine Group A
8 weekly virtual sessions plus online platform
Behavioral: 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
Other Names:
  • Migraine Group A
Experimental: Brain Education and WELLness with Migraine Group B
8 weekly virtual sessions plus online platform
Behavioral: 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
Other Names:
  • Migraine Group B

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Depression assessed using Patient Health Questionnaire (PHQ-8) Questionnaire - Change in Depression from baseline to 8 weeks
Time Frame: Immediately post-intervention at 8 weeks
PHQ-8 has equivalent diagnostic depression accuracy as PHQ-9 and will be used to assess depression. PHQ-8 scores range from 0 to 24. Each of the 9 items can be scored from 0 ("not at all") to 3 ("nearly every day"). Cut-points of 5, 10, 15, and 20 represent the thresholds for mild, moderate, moderately severe, and severe depression, respectively.
Immediately post-intervention at 8 weeks
Pain Catastrophizing quantified using Pain Catastrophizing Scale (PCS) - Change in Pain catastrophizing from baseline to 8 weeks
Time Frame: Immediately post-intervention at 8 weeks
This 13-item scale quantifies an individual's pain experience. Unlike other scales, this does not require for the person to be in pain while completing it. Patients are asked to rate the degree to which they have any of the thoughts described in the questionnaire using a 5-point Likert scale ranging from 0 (never) to 4 (always). The total score is the sum of the scores for the individual items, and ranges from 0 to 52.
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
Time Frame: Immediately post-intervention at 8 weeks
A 25-item scale that assesses patient's beliefs in their ability to prevent and/or appropriately manage their headaches and headache-related disability; it has been shown to be valid and reliable. This scale consists of 25 items rated on a 7-point scale that ranges from 1 strongly disagree to 7 strongly agree. Total scores range from 0-175, higher scores reflect more self-efficacy.
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
Time Frame: Post-intervention at 20 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.
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
Time Frame: Post-intervention at 32 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.
Post-intervention at 32 weeks
Anxiety assessed using Generalized Anxiety Disorder-7 (GAD-7) at 8 weeks - Change in anxiety from baseline to 8 weeks
Time Frame: Immediately post-intervention at 8 weeks
This is a 7-item scale that quantifies and assess the severity of generalized anxiety disorder, over the past 2 weeks - GAD-7 score of 0-4 (none), 5-9 (mild), 10-14 (moderate), and 15-21 (severe)
Immediately post-intervention at 8 weeks
Quality of Life assessed using Migraine Specific Quality of Life version 2.1 (MSQL v2.1) at 8 weeks
Time Frame: Immediately post-intervention at 8 weeks
This is a 14-item questionnaire that measures how migraines affect a patient's daily life and is a highly reliable and valid instrument. The raw scores are transformed to a 0-100 scale and higher scores reflect greater quality of life
Immediately post-intervention at 8 weeks
Migraine frequency using the daily and 7-day recall headache log at 8 weeks - Change in migraine frequency from baseline to 8 weeks
Time Frame: Immediately post-intervention at 8 weeks
Participants will complete a daily headache log (<10 items) that captures frequency, along with a 7-day recall headache log (<10 items).
Immediately post-intervention at 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wake Forest University Health Sciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Center for Complementary and Integrative Health (NCCIH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rebecca E Wells, MD, MPH, Wake Forest University Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 31, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 4, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 14, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00079570
  • R01AT011502 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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