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MigraineNCT05987592

BE WELL With Migraine: Brain Education and WELLness With Migraine

A study testing Brain Education and WELLness with Migraine Group A and Brain Education and WELLness with Migraine Group B in people with Migraine, run by Wake Forest University Health Sciences at 3 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Migraine
What is being tested?
Brain Education and WELLness with Migraine Group A and Brain Education and WELLness with Migraine Group B
Could I receive a placebo?
No, everyone receives an active treatment
How many people
286 participants
Where
3 sitesUnited States
Study dates
31 Jul 2024to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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 locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Nicole Tamol contact

336-978-1362

Help4Migraine@wfusm.edu

United States3 sites, 3 recruiting

  • Cambridge Health Alliance - Center for Mindfulness and Compassion

    Cambridge, Massachusetts, 02141

    Alexandra Comeau, acomeau@challiance.org

    Paula Gardner, MD, MPH

    Not yet recruiting

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229-3039

    Leigh A Chamberlin, LeighAnn.Chamberlin@cchmc.org

    Scott Powers, PhD, ABPP

    Not yet recruiting

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

    Nicole Tamol, 336-978-1362, Help4Migraine@wfusm.edu

    Rebecca E Wells, MD, MPH

    Recruiting

Other trials in United States

About this study

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.

Read the 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.

Conditions
Migraine
Being tested
Brain Education and WELLness with Migraine Group A, Brain Education and WELLness with Migraine Group B
Keywords
Migraine, Migraine without aura, Migraine with aura, behavioral, mind-body, integrative, virtual, online
Medical subject headings
Migraine Disorders, Migraine without Aura, Migraine with Aura, Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brain Education and WELLness with Migraine Group ABehavioural

    Also called 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 BBehavioural

    Also called 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

Study groups in NCT05987592
Study groupRoleWhat they receive
Brain Education and WELLness with Migraine Group AExperimental8 weekly virtual sessions plus online platform
Receives: Behavioral: Brain Education and WELLness with Migraine Group A
Brain Education and WELLness with Migraine Group BExperimental8 weekly virtual sessions plus online platform
Receives: Behavioral: Brain Education and WELLness with Migraine Group B

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Immediately post-intervention at 8 weeks

Secondary outcomes (8)

  1. Depression assessed using Patient Health Questionnaire (PHQ-8) Questionnaire - Change in Depression from baseline to 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.

    Measured: Immediately post-intervention at 8 weeks

  2. Pain Catastrophizing quantified using Pain Catastrophizing Scale (PCS) - Change in Pain catastrophizing from baseline to 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.

    Measured: Immediately post-intervention at 8 weeks

  3. Self-Efficacy assessed with the Headache Management Self-Efficacy Scale (HMSE) - Change in Self-efficacy from baseline to 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.

    Measured: Immediately post-intervention at 8 weeks

  4. Disability assessed using monthly Migraine Disability Assessment (mMIDAS) at 20 weeks - Change in migraine disability from baseline to 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.

    Measured: Post-intervention at 20 weeks

  5. Disability assessed using monthly Migraine Disability Assessment (mMIDAS) at 32 weeks - Change in migraine disability from baseline to 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.

    Measured: Post-intervention at 32 weeks

  6. Anxiety assessed using Generalized Anxiety Disorder-7 (GAD-7) at 8 weeks - Change in anxiety from baseline to 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)

    Measured: Immediately post-intervention at 8 weeks

  7. Quality of Life assessed using Migraine Specific Quality of Life version 2.1 (MSQL v2.1) 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

    Measured: Immediately post-intervention at 8 weeks

  8. Migraine frequency using the daily and 7-day recall headache log at 8 weeks - Change in migraine frequency from baseline to 8 weeks

    Participants will complete a daily headache log (<10 items) that captures frequency, along with a 7-day recall headache log (<10 items).

    Measured: Immediately post-intervention at 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2023
  2. Study start31 Jul 2024
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Two-arm parallel assignment in which one group receives treatment A and the other group receives treatment B
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
286 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05987592
Sponsor's protocol ID
IRB00079570
Other IDs
R01AT011502
Status last verified
Apr 2026
First submitted
4 Aug 2023
Last updated
12 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 41065019

Questions about this trial

What is this clinical trial studying?

A study testing Brain Education and WELLness with Migraine Group A and Brain Education and WELLness with Migraine Group B in people with Migraine, run by Wake Forest University Health Sciences at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nicole Tamol (336-978-1362, Help4Migraine@wfusm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05987592, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.

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