286 Participants Needed

Brain Education and Wellness Program for Migraine

Recruiting at 2 trial locations
JF
Overseen ByJunelyn Floyd
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Wake Forest University Health Sciences
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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.

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.12345

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.12345

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.12367

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.

Research Team

RE

Rebecca E Wells, MD, MPH

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

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
See 5 more

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.
See 7 more

Timeline

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)

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Brain Education and WELLness with Migraine Group BExperimental Treatment1 Intervention
8 weekly virtual sessions plus online platform
Group II: Brain Education and WELLness with Migraine Group AExperimental Treatment1 Intervention
8 weekly virtual sessions plus online platform

Find a Clinic Near You

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+

Findings from Research

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.
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.
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.
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]

References

Meditation for migraines: a pilot randomized controlled trial. [2022]
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]
Effectiveness of Mindfulness Meditation vs Headache Education for Adults With Migraine: A Randomized Clinical Trial. [2022]
Effects of mindfulness-based stress reduction on perceived stress and psychological health in patients with tension headache. [2022]
Effectiveness of mindfulness-based stress reduction as a non-drug preventive intervention in patients with migraine - a systematic review with meta-analyses. [2023]
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]
Multimodal biofeedback in the treatment of migraine. [2019]
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