Brain Education and Wellness Program for Migraine

Recruiting at 2 trial locations

Overseen By Junelyn Floyd

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Unstable medical condition, Medication overuse, Heavy alcohol, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 29

Duration: 8 weeks

286 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

No, you can stay on all your current medications during this study. However, you need to maintain stable dosages throughout the study.

Is the Brain Education and Wellness Program for Migraine safe for humans?

Mindfulness-based stress reduction (MBSR), a component of the Brain Education and Wellness Program, is generally considered safe for humans and has no known side effects. It has been used effectively for several chronic pain conditions, including migraines, without reported safety concerns. ^{1 2 3 4 5}

How does the Brain Education and Wellness Program for Migraine differ from other migraine treatments?

The Brain Education and Wellness Program for Migraine, which includes Mindfulness-Based Stress Reduction (MBSR), is unique because it is a non-drug treatment that focuses on meditation and stress reduction, offering an inexpensive option without side effects. Unlike medications, it addresses both pain and psychological well-being, improving sleep quality and potentially reducing headache frequency. ^{1 2 4 6 7}

What data supports the effectiveness of the Brain Education and Wellness Program for Migraine treatment?

Research suggests that mindfulness-based stress reduction (MBSR), a key component of the program, may help reduce depressive symptoms in migraine patients and has shown promise in small studies for migraine therapy, although more research is needed to confirm its effectiveness. ^{1 2 3 4 5}

Who Is on the Research Team?

Rebecca E Wells, MD, MPH

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for adults with migraines occurring 4-20 days a month, who've had migraines for at least a year. Participants must be fluent in English, able to attend 8 weekly online classes, and willing to keep headache logs. Pregnant women up to 16 weeks can join. Those with heavy alcohol/drug use, other clinical trial participation, meditation experience or unstable medical conditions are excluded.

Inclusion Criteria

Fluent in English

I have migraines, with headaches occurring 4-20 days a month.

Completion of technology onboarding with the online platform

Exclusion Criteria

Major unstable medical/psychiatric condition that could be unsafe for participants or for the group environment

Participation in another intervention clinical trial or one that would interfere in this study

I have headaches from overusing my migraine medication.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (virtual)

Treatment

Participants engage in 8 weekly virtual sessions plus use of an online platform

8 weeks

8 visits (virtual)

Follow-up

Participants are monitored for changes in migraine-related outcomes post-intervention

12 weeks

All assessments and surveys completed virtually

Long-term Follow-up

Participants' migraine disability is assessed at 20 and 32 weeks post-intervention

24 weeks

Assessments at 20 and 32 weeks (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Brain Education and WELLness with Migraine Group A
• Brain Education and WELLness with Migraine Group B

Trial Overview The study compares two non-drug virtual treatments aimed at improving life quality for migraine sufferers through an online platform over eight sessions. The effectiveness of these interventions will be evaluated while participants continue their usual migraine medications.

How Is the Trial Designed?

Group I: Brain Education and WELLness with Migraine Group B Experimental Treatment 1 Intervention

8 weekly virtual sessions plus online platform

Group II: Brain Education and WELLness with Migraine Group A Experimental Treatment 1 Intervention

8 weekly virtual sessions plus online platform

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Published Research Related to This Trial

The 8-week mindfulness-based stress reduction (MBSR) course was found to be safe and feasible for adults with migraines, showing excellent adherence and no adverse events during the study with 19 participants.

While the study did not find statistically significant changes in migraine frequency, MBSR participants experienced shorter headache duration and improved self-efficacy and mindfulness, suggesting potential benefits that warrant further investigation in larger trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meditation for migraines: a pilot randomized controlled trial. Wells, RE., Burch, R., Paulsen, RH., et al.[2022]

This study is a pilot trial investigating the effectiveness of mindfulness-based stress reduction (MBSR) for treating moderate-to-severe episodic migraines, involving approximately 60 participants and lasting 8 weeks.

MBSR is a low-cost intervention with no known side effects, and if successful, it could lead to a larger clinical trial aimed at confirming its effectiveness in reducing headache days for migraine sufferers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conducting a pilot randomized controlled trial of community-based mindfulness-based stress reduction versus usual care for moderate-to-severe migraine: protocol for the Mindfulness and Migraine Study (M&M). Pressman, A., Law, H., Stahl, R., et al.[2020]

In a study of 89 adults with frequent migraines, both mindfulness-based stress reduction (MBSR) and headache education led to a similar reduction in migraine days, indicating that both interventions can be effective for managing migraine frequency.

However, MBSR showed significant improvements in disability, quality of life, self-efficacy, and pain perception compared to headache education, suggesting that MBSR may provide broader benefits beyond just reducing the number of migraine days.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Mindfulness Meditation vs Headache Education for Adults With Migraine: A Randomized Clinical Trial. Wells, RE., O'Connell, N., Pierce, CR., et al.[2022]

In a randomized clinical trial involving 60 patients with tension-type headaches, mindfulness-based stress reduction (MBSR) significantly decreased perceived stress and improved mental health, as measured by the Brief Symptom Inventory (BSI) and Perceived Stress Scale (PSS).

The MBSR group showed a substantial reduction in BSI scores from 1.63 to 0.73 after the intervention, and perceived stress scores decreased from 16.96 to 12.7, indicating that MBSR is an effective treatment for managing stress and mental health in headache patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of mindfulness-based stress reduction on perceived stress and psychological health in patients with tension headache. Omidi, A., Zargar, F.[2022]

A systematic review of four randomized controlled trials involving 275 adult migraine patients found that mindfulness-based stress reduction (MBSR) did not significantly reduce migraine frequency, indicating limited efficacy in this area (SMD: -0.23).

However, MBSR was associated with a significant reduction in depressive symptoms among patients (SMD: -0.59), suggesting it may help improve mental health in migraine sufferers, though more high-quality studies are needed to confirm its overall effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of mindfulness-based stress reduction as a non-drug preventive intervention in patients with migraine - a systematic review with meta-analyses. Prohaska, S., Matthias, K.[2023]

In a study of 98 patients with episodic migraine, mindfulness-based stress reduction (MBSR) significantly improved sleep quality over 20 weeks, which may have contributed to a 50% reduction in headache frequency post-intervention.

While MBSR improved sleep, there were no significant changes in anxiety, depression, or stress levels, indicating that MBSR's primary benefit may lie in enhancing sleep quality rather than directly addressing these psychosocial factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced mindfulness-based stress reduction in episodic migraine-effects on sleep quality, anxiety, stress, and depression: a secondary analysis of a randomized clinical trial. Burrowes, SAB., Goloubeva, O., Stafford, K., et al.[2023]

In a study with 24 migraine sufferers, those who practiced a combination of temporal cooling, frontalis relaxation, and progressive muscular relaxation experienced the most significant relief from headaches.

Control subjects who did not engage in these techniques reported no headache relief, highlighting the effectiveness of the behavioral strategies over relaxation exercises alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multimodal biofeedback in the treatment of migraine. Gamble, EH., Elder, ST.[2019]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Meditation for migraines: a pilot randomized controlled trial. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Conducting a pilot randomized controlled trial of community-based mindfulness-based stress reduction versus usual care for moderate-to-severe migraine: protocol for the Mindfulness and Migraine Study (M&M). [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of Mindfulness Meditation vs Headache Education for Adults With Migraine: A Randomized Clinical Trial. [2022]

4. India pubmed.ncbi.nlm.nih.gov

Effects of mindfulness-based stress reduction on perceived stress and psychological health in patients with tension headache. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness of mindfulness-based stress reduction as a non-drug preventive intervention in patients with migraine - a systematic review with meta-analyses. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Enhanced mindfulness-based stress reduction in episodic migraine-effects on sleep quality, anxiety, stress, and depression: a secondary analysis of a randomized clinical trial. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Multimodal biofeedback in the treatment of migraine. [2019]