Mindfulness Program for Migraines

Overseen By Michelle Harmon, BS

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Cancer, Epilepsy, Psychosis, others

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

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mindfulness program called BREATHE-Migraine to determine its suitability for teenagers with frequent migraines. The main aim is to assess the program's feasibility and acceptance, which will inform a future, larger study to evaluate its effectiveness in reducing headaches. Participants will engage in six weekly sessions, each lasting one hour, conducted remotely in a group setting. Teens aged 13–18, diagnosed with migraines and experiencing eight or more headache days each month, may qualify for this trial. As an unphased trial, this study provides a unique opportunity for teens to contribute to innovative migraine research and potentially enhance their headache management.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that this mindfulness program is safe for adolescents with migraines?

Research has shown that mindfulness activities, such as the BREATHE-Migraine program, are safe for people with migraines. Studies on similar programs have found them easy for participants to handle. Most people do not experience serious side effects. In fact, many report benefits, such as fewer migraine days. This suggests that mindfulness practices can be a gentle and safe way to manage migraines. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the BREATHE-Migraine program because it offers a unique, mindfulness-based approach to managing migraines. Unlike traditional treatments like medications, which often focus on relieving symptoms or preventing migraine attacks, BREATHE-Migraine emphasizes stress reduction and mental well-being through mindfulness. This treatment is delivered remotely in a group setting, making it accessible and convenient for participants. By potentially providing a drug-free option with fewer side effects, BREATHE-Migraine could become an appealing alternative for those seeking holistic migraine management.

What evidence suggests that the BREATHE-Migraine program might be an effective treatment for migraines?

Research shows that mindfulness programs can help reduce migraines. In this trial, participants will receive the BREATHE-Migraine program, consisting of six weekly 1-hour sessions of a remotely-delivered mindfulness-based intervention in a group setting. One study found that people who practiced mindfulness experienced fewer migraine days each month. Another study demonstrated that adding mindfulness to regular treatments reduced headache frequency and improved the quality of life for those with chronic migraines. Additionally, mindfulness training significantly lessened the impact of headaches on daily activities. These findings suggest mindfulness could be a useful tool for managing migraines. ^{1 6 7 8 9}

Who Is on the Research Team?

Michelle A Clementi, PhD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

This trial is for adolescents aged 13 to 18 who suffer from chronic migraines, experiencing at least 8 headache days per month and have a mild headache-related disability. They must be diagnosed with migraine by a medical provider but cannot have major health issues like cancer or epilepsy, active psychosis, suicidal thoughts, or be in frequent therapy sessions.

Inclusion Criteria

My headaches cause some level of disability.

I have been diagnosed with migraine by a doctor.

I experience 8 or more headache days each month.

Exclusion Criteria

I have a major health condition like cancer or epilepsy.

I do not have active psychosis or thoughts of harming myself.

I am receiving weekly or bi-weekly therapy from a licensed mental health professional.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase I - Adaptation

Feedback from interviews with teens, parents, and healthcare providers to adapt the mindfulness-based intervention

Not specified

Phase II - Treatment

Participants receive 6 weekly 1-hour sessions of a remotely-delivered mindfulness-based intervention in a group setting

6 weeks

6 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• BREATHE-Migraine

Trial Overview The study is testing 'BREATHE-Migraine,' a mindfulness-based intervention tailored for teenagers with chronic migraines. The aim is to see if this approach is practical and well-received as groundwork for future trials focused on how it affects headache symptoms.

How Is the Trial Designed?

Group I: BREATHE-Migraine Experimental Treatment 1 Intervention

Participants will receive 6 weekly 1-hour sessions of a remotely-delivered mindfulness-based intervention in a group setting.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Children's Hospital Colorado

Collaborator

Trials

121

Recruited

5,135,000+

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]

In a study of 44 patients with chronic migraine and medication overuse, both mindfulness-based training and conventional prophylactic medications led to similar reductions in headache frequency and medication intake over one year.

Both treatment groups achieved significant improvements, with many patients no longer meeting the criteria for chronic migraine, indicating that mindfulness can be an effective alternative to traditional medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness and pharmacological prophylaxis after withdrawal from medication overuse in patients with Chronic Migraine: an effectiveness trial with a one-year follow-up. Grazzi, L., Sansone, E., Raggi, A., 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]

Participants in mindfulness-based stress reduction (MBSR) reported significant changes in their pain perception and response to migraine attacks, leading to improved overall well-being and earlier recognition of migraine symptoms for better management.

Mindfulness practices helped reduce negative feelings associated with migraines, such as fear and anxiety, while increasing positive factors like self-acceptance and self-compassion, suggesting that mindfulness can effectively address both the psychological and physical aspects of migraine management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanisms of mindfulness in patients with migraine: Results of a qualitative study. Estave, PM., Margol, C., Beeghly, S., et al.[2023]

Mindfulness-Based Cognitive Therapy for Migraine (MBCT-M) significantly reduces headache-related disability, particularly in individuals with episodic migraine, as shown in a study of 60 participants.

The therapy was more effective for episodic migraine sufferers, reducing severe disability by 40%, compared to only a 16.4% reduction in those with chronic migraine, indicating that the benefits of MBCT-M vary based on the type of migraine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Response to Mindfulness-Based Cognitive Therapy Differs Between Chronic and Episodic Migraine. Seng, EK., Conway, AB., Grinberg, AS., et al.[2022]

In a pilot study involving 30 female patients with chronic migraine, combining mindfulness sessions with anodal transcranial direct-current stimulation (tDCS) over the left dorsolateral prefrontal cortex significantly improved migraine-related outcomes compared to a sham treatment.

The active treatment group showed better results in all evaluated measures, particularly in the Headache Impact Test (HIT-6), indicating that this combined approach may enhance attention and provide analgesic benefits for chronic migraine sufferers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Synergism of Mindfulness Practice Associated With Transcranial Direct-Current Stimulation in Chronic Migraine: Pilot, Randomized, Controlled, Double-Blind Clinical Trial. Pimenta, LDS., de Araújo, ELM., Silva, JPDS., et al.[2021]

Acceptance and mindfulness-based interventions significantly improve disability in adults with migraines, with a moderate effect size (SMD = -0.38) based on a systematic review of clinical trials.

However, these interventions did not show significant effects on reducing medication use or headache frequency, indicating their primary benefit lies in enhancing overall functioning rather than directly controlling migraine symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A meta-analytic review of acceptance-based interventions for migraine. Polk, AN., Smitherman, TA.[2023]

In a preliminary phase-III trial involving 177 patients with chronic migraine and medication overuse headache, adding six sessions of mindfulness-based therapy to standard treatment significantly reduced headache frequency and medication intake compared to standard treatment alone.

54.2% of patients receiving standard treatment achieved a 50% reduction in headache days, while 75.9% of those receiving standard treatment plus mindfulness did, indicating that mindfulness is a beneficial add-on therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Preliminary Analysis on the Feasibility and Short-Term Efficacy of a Phase-III RCT on Mindfulness Added to Treatment as Usual for Patients with Chronic Migraine and Medication Overuse Headache. Grazzi, L., Raggi, A., Guastafierro, E., et al.[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 involving 177 patients with Chronic Migraine and Medication Overuse Headache, a mindfulness-based treatment added to standard care significantly reduced headache frequency by 78.4% compared to 48.3% in the standard care group after 12 months.

The mindfulness intervention also led to improvements in quality of life, disability, medication intake, and overall healthcare costs, demonstrating its efficacy as a complementary treatment for migraine management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of mindfulness added to treatment as usual in patients with chronic migraine and medication overuse headache: a phase-III single-blind randomized-controlled trial (the MIND-CM study). Grazzi, L., D'Amico, D., Guastafierro, E., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7737157/

Effectiveness of Mindfulness Meditation vs Headache ... Participants in both groups had fewer migraine days at 12 weeks (MBSR: −1.6 migraine days per month; 95% CI, −0.7 to −2.5; headache education: − ...

2. withpower.com withpower.com/trial/phase-migraine-5-2024-3af8b

Mindfulness Program for Migraines · Info for Participants Another study found that adding mindfulness to regular treatment helped reduce headache frequency and improved quality of life for patients with chronic ...

3. americanheadachesociety.org americanheadachesociety.org/research/library/new-data-on-efficacy-of-mindfulness-based-interventions-in-migraine-to-be-shared-at-ahs-61st-annual-scientific-meeting

New Data on Efficacy of Mindfulness-Based… After 4 months, those who received MBCT-M had significant reductions in headache-related disability compared to those in the treatment as usual ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7484477/

The mindful migraine: does mindfulness-based stress ... The study demonstrated reduction in the primary clinical outcome, number of headache days per month, from baseline to 20 weeks for both MBSR+ and stress ...

5. thejournalofheadacheandpain.biomedcentral.com thejournalofheadacheandpain.biomedcentral.com/articles/10.1186/s10194-023-01630-0

Efficacy of mindfulness added to treatment as usual in patients ... Patients in the TaU + MIND group outperformed those in TaU for the primary endpoint (78.4% vs. 48.3%; p < 0.0001), and showed superior ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7213534/

Mindfulness in Migraine. A narrative review - PMC We review efficacy and potential mechanisms of MBIs for migraine, including mindfulness-based stress reduction (MBSR) and mindfulness-based cognitive therapy ( ...

7. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2774130

Effectiveness of Mindfulness Meditation vs Headache ... This randomized clinical trial examines whether mindfulness-based stress reduction and headache education improve migraine day frequency and ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT02133209

MRI Outcomes of Mindfulness Meditation for Migraine The SMH group will have 12 sessions spread out in a similar fashion to MBSR. Clinical outcomes are compared between groups at 3, 6, and 12 months to assess ...

9. neuro.jmir.org neuro.jmir.org/2025/1/e68369

Experiences of a Neurofeedback-Based Mindfulness ... In a recent unblinded trial, participants reported reduced monthly migraine days and acute medication use after a 10-day mindfulness meditation ...