Mindfulness vs Education for Migraine

(HEADS-UP Trial)

MA
MT
AC
Overseen ByArlet Campuzano, B.S.
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: University of Colorado, Denver
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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?

MA

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

I have headaches at least 6 days each month.
I am between 12 and 17 years old.
I have been diagnosed with migraine by my doctor.
See 3 more

Exclusion Criteria

I have had at least 4 sessions of pain management therapy in the past 6 months.
Current psychiatric crisis (e.g., active suicidal ideation)
I do not have cognitive or developmental issues that prevent me from joining the study.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to a 6-week telehealth group program: either a mindfulness-based intervention or headache education

6 weeks
6 virtual sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks
1 virtual visit post-intervention, 1 virtual visit at 12-week follow-up

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

Group I: BREATHE with Headache (BREATHE-HA)Experimental Treatment1 Intervention
Group II: Enhanced Standard-of-Care: Headache EducationActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials
1,842
Recruited
3,028,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials
886
Recruited
677,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials
1,403
Recruited
655,000+

Citations

A 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.

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 ...