Mindfulness vs Education for Migraine
(HEADS-UP Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if virtual group programs can help teens manage migraines more effectively. It compares two telehealth options: one focuses on mindfulness techniques (BREATHE with Headache, or BREATHE-HA), and the other provides education about headaches (Enhanced Standard-of-Care: Headache Education). Teens aged 12 to 17 who experience migraines at least six days a month and face daily challenges due to these headaches might be suitable candidates. Participants should not have recently undergone extensive behavioral therapy for pain management.
As an unphased trial, this study offers teens a unique opportunity to explore innovative ways to manage migraines through virtual support.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications. However, you must be on a stable dose of any migraine prevention medication for at least 4 weeks before joining.
What prior data suggests that these telehealth group interventions are safe for adolescents with migraine?
Research has shown that mindfulness and breathing exercises can safely and effectively help manage migraines. Studies on breathing techniques, such as alternate nostril breathing, indicate they can reduce migraine frequency and severity without harmful effects. Participants in these studies experienced fewer migraines and improved quality of life, with no negative side effects reported.
Relaxation and paced breathing exercises are easy to tolerate and safely manage symptoms. These methods offer a non-invasive way to handle migraines, reducing the need for medication and empowering individuals to control their condition. Overall, mindfulness and breathing exercises present promising options for gentle and safe migraine relief.12345Why are researchers excited about this trial?
Researchers are excited about these treatments for migraines because they explore non-pharmacological options that could provide relief without the side effects of medication. The BREATHE with Headache (BREATHE-HA) program is particularly unique because it uses a mindfulness-based approach tailored for adolescents, delivered via telehealth, making it accessible and convenient. Meanwhile, the Enhanced Standard-of-Care: Headache Education arm emphasizes education delivered remotely, which may empower patients with knowledge and self-management strategies. These approaches could offer new avenues for managing migraines by focusing on mental and educational strategies rather than just medication.
What evidence suggests that this trial's treatments could be effective for migraine?
Research has shown that mindfulness can help reduce migraine symptoms. In this trial, participants will join one of two groups: the BREATHE with Headache (BREATHE-HA) mindfulness-based intervention or the Enhanced Standard-of-Care: Headache Education. A study involving over 800 people, including some with headaches, found that a telehealth mindfulness program significantly improved their condition. Another review found that mindfulness-based activities eased chronic headache symptoms. Participants in mindfulness programs reported fewer migraine attacks and less disability related to headaches. Mindfulness not only reduces pain but also enhances quality of life and mental well-being.678910
Who Is on the Research Team?
Michelle A Clementi, Ph.D.
Principal Investigator
University of Colorado, Denver
Are You a Good Fit for This Trial?
This trial is for adolescents aged 12-17 who have been diagnosed with migraine, experience at least 6 headache days per month, have some disability from headaches, are on a stable medication dose or none, and can understand English. Those already in behavioral pain therapy recently or with certain mental health or cognitive issues can't join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to a 6-week telehealth group program: either a mindfulness-based intervention or headache education
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- BREATHE with Headache (BREATHE-HA)
- Enhanced Standard-of-Care: Headache Education
Trial Overview
The study compares two virtual group programs for teens with migraines: one teaches mindfulness strategies (BREATHE-HA), while the other provides education about headaches. Both are delivered via telehealth to see which approach works better and is more acceptable.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Mindfulness-based intervention adapted for adolescents with migraine, delivered as a telehealth group program
Headache education, delivered as a telehealth group program
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Colorado, Denver
Lead Sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Citations
1.
migrainecollaborative.org
migrainecollaborative.org/a-telehealth-mindfulness-based-intervention-for-pain-effective-and-practicalA Telehealth Mindfulness-Based Intervention for Pain
A randomized clinical trial in more than 800 veterans, including some with headache, showed that the intervention was effective, ...
Efficacy of mindfulness-based intervention for the treatment of ...
This review aims to assess the impact of MBSR/MBCT in alleviating the symptoms of chronic headaches.
Mindfulness Program for Migraines · Info for Participants
Research shows that mindfulness programs can help reduce migraines. In this trial, participants will receive the BREATHE-Migraine program, consisting of six ...
Results - Behavioral Interventions for Migraine Prevention
(2021) reported outcome data on migraine/headache attack frequency, and results statistically significantly favored ACT (SMD corresponding to 2.3 fewer ...
Experiences of a Neurofeedback-Based Mindfulness ...
Results: Participants spoke to 3 categories of experiences: the positive impact of neurofeedback-based mindfulness meditation on migraine ...
The impact of alternate nostril breathing on the severity and ...
ANB significantly reduced migraine frequency and disability, making it a promising non-invasive and accessible treatment option for migraine management.
Yoga-based breathing and relaxation as adjunctive ...
A 12-week pranayama and relaxation (P + R) program significantly reduced headache frequency in chronic migraine patients. •. Participants in the P + R group ...
Slow Diaphragmatic Breathing for Chronic Migraine ...
Turning to breathing as a first-line treatment may help reduce dependency on medications and increase patient self-efficacy, improving migraine symptoms and ...
Effectiveness of eye movement exercise and diaphragmatic ...
EME+J or DB+J can be an effective and safe method with no adverse effects to decrease the symptoms of migraine attacks.
10.
americanmigrainefoundation.org
americanmigrainefoundation.org/resource-library/breathing-exercises-for-migraine/Relaxation and Paced Breathing Exercises for Migraine
Research has shown that the ideal routine for people with migraine is to do breathing and relaxation exercises for 20 minutes per day, more days ...
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