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: Unknown

25 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this study is to assess feasibility and acceptability of a mindfulness-based intervention adapted for adolescents with migraine to inform a future randomized trial assessing effects of the intervention on headache-related outcomes.

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 data supports the idea that Mindfulness Program for Migraines (also known as: BREATHE-Migraine) is an effective treatment?

The available research shows that mindfulness programs can be effective for treating migraines. In one study, patients with chronic migraines who participated in mindfulness sessions combined with another therapy showed better results in reducing headache impact compared to those who did not receive the additional therapy. Another study found that adding mindfulness to regular treatment helped reduce headache frequency and improved quality of life for patients with chronic migraines and medication overuse headaches. These findings suggest that mindfulness can be a helpful addition to traditional migraine treatments. ^{1 2 3 4 5}

What safety data exists for the mindfulness program for migraines?

The mindfulness-based stress reduction (MBSR) program, evaluated in several studies, has been shown to be safe for migraine patients. It is described as having no known side effects and is feasible as an add-on treatment. Drop-out rates in trials were similar between groups receiving usual care and those receiving mindfulness, indicating good tolerability. Overall, the studies suggest that MBSR is a safe intervention for managing migraines. ^{2 6 7 8 9}

Is the treatment BREATHE-Migraine a promising treatment for migraines?

Yes, BREATHE-Migraine, which is a mindfulness-based stress reduction program, is a promising treatment for migraines. It is inexpensive, has no known side effects, and has shown positive results in reducing migraine symptoms in several studies. ^{4 5 6 7 10}

Research Team

Michelle A Clementi, PhD

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

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.

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 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 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]

References

1. Switzerland 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. [2021]

2. England 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). [2023]

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

A meta-analytic review of acceptance-based interventions for migraine. [2023]

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

Response to Mindfulness-Based Cognitive Therapy Differs Between Chronic and Episodic Migraine. [2022]

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

Mechanisms of mindfulness in patients with migraine: Results of a qualitative study. [2023]

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

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

7. 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]

8. Switzerland 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. [2023]

9. 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]

10. England 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. [2022]