Mind-Body Intervention for Migraines

Overseen By Masumi Prasad

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Beth Israel Deaconess Medical Center

Disqualifiers: Organic headaches, Chronic pain, Dementia, Addiction, Schizophrenia

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

Compensation: Varies

Number of Visits: 5

Duration: 20 weeks

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a mind-body technique to help manage chronic migraines, focusing on how this approach can impact migraine symptoms and improve future study designs. Individuals who experience migraines at least five days a month and find these headaches significantly affect their daily life might be suitable candidates. Participants should be open to trying new methods and able to join remote sessions. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could shape future migraine treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators.

What prior data suggests that this protocol is safe for treating migraines?

Research has shown that mind-body treatments are generally safe for people with migraines. These treatments can reduce migraine frequency by 35-50%, similar to some medications, but with fewer side effects. Studies have found these methods to be well-tolerated, and small studies have demonstrated their safety and practicality. Participants often report improved migraine management without major side effects. Overall, current evidence suggests that mind-body treatments are a safe option for managing migraines. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mind-Body Intervention for migraines because it offers a fresh, holistic approach distinct from the usual medication-based treatments like triptans and beta-blockers. This intervention focuses on teaching a novel technique through lectures and group discussions, emphasizing the connection between the mind and body to manage migraines. By potentially reducing reliance on drugs and their side effects, this method could provide a more natural and sustainable way to alleviate migraine symptoms.

What evidence suggests that this mind-body intervention is effective for migraines?

Research has shown that mind-body techniques, such as mindfulness meditation, can reduce the frequency of migraines for some individuals. One study found that 78.4% of participants who added mindfulness to their usual treatment experienced improvements, compared to 48.3% who received only the usual treatment. Participants also reported positive experiences with mindfulness using neurofeedback, suggesting it might aid in managing migraines. However, a review of several studies found no significant change in headache duration, indicating that results can vary. Overall, these methods have shown promise in enhancing life quality and reducing the impact of migraines for some people. Participants in this trial will receive a novel mind-body intervention taught through lectures and group discussion sessions. ^{1 2 6 7 8}

Who Is on the Research Team?

Michael W Donnino, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals who frequently experience chronic migraines. Participants should be interested in exploring non-medical treatments and willing to follow the study's mind-body intervention protocol. Specific eligibility details are not provided, but typically include age range, migraine frequency, and overall health status.

Inclusion Criteria

I have been diagnosed with migraines.

A score of ≥ 50 on the Headache Impact Test-6 self-report survey (moderate impact)

I experience migraines on 5 or more days each month.

Exclusion Criteria

I do not have chronic pain conditions like fibromyalgia that could affect pain assessments.

Major psychiatric comorbidity (e.g., schizophrenia). Anxiety and mild-moderate depression are not considered exclusions.

I have headaches caused by a medical condition like cancer or sinus infection.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a mind-body intervention through lectures and group discussion sessions

20 weeks

5 visits (in-person) at baseline, 4, 8, 13, and 20 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Mind-Body Intervention

Trial Overview

The study is testing a mind-body intervention designed to alleviate chronic migraines. It aims to gather preliminary data on how feasible this approach is based on protocols used for similar conditions and will assess various tools for measuring its effectiveness.

How Is the Trial Designed?

Group I: Mind-Body Intervention Experimental Treatment 1 Intervention

A Novel Mind body technique for the intervention will be taught in lectures and group discussion sessions

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

Published Research Related to This Trial

Mindfulness-based interventions (MBIs), such as mindfulness-based stress reduction (MBSR) and mindfulness-based cognitive therapy (MBCT), show promise as non-pharmacological treatments for migraine, potentially improving headache-related disability and psychological well-being.

While current research is mostly based on small pilot trials, further studies are needed to determine the most effective ways to implement MBIs, including optimal dosage and delivery methods, as they may serve as valuable tools in a comprehensive migraine management plan.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness in migraine: A narrative review. Wells, RE., Seng, EK., Edwards, RR., et al.[2021]

An Internet-based multimodal behavior treatment (MBT) program for migraine was found to be effective, with 40% of participants experiencing a 50% or greater reduction in migraine frequency over 11 months, compared to a control group.

The addition of hand massage did not show any significant effect on migraine outcomes, indicating that the MBT alone was responsible for the improvements observed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multimodal behavioral treatment of migraine: an Internet-administered, randomized, controlled trial. Hedborg, K., Muhr, C.[2021]

In a study with 24 migraine sufferers, those who practiced a combination of temporal cooling, frontalis relaxation, and progressive muscular relaxation experienced the most significant relief from headaches.

Control subjects who did not engage in these techniques reported no headache relief, highlighting the effectiveness of the behavioral strategies over relaxation exercises alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multimodal biofeedback in the treatment of migraine. Gamble, EH., Elder, ST.[2019]

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]

The RELAXaHEAD app, designed for migraine sufferers, was found to be user-friendly and practical, with 92% of participants expressing willingness to use it again after testing its features, including a headache diary and progressive muscle relaxation (PMR).

Participants reported that the PMR feature helped improve their stress and mood, indicating its potential as a beneficial nonpharmacologic treatment option for managing chronic pain conditions like migraines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

User Design and Experience Preferences in a Novel Smartphone Application for Migraine Management: A Think Aloud Study of the RELAXaHEAD Application. Minen, MT., Jalloh, A., Ortega, E., et al.[2020]

Citations

1.

pmc.ncbi.nlm.nih.gov

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

Effectiveness of Mindfulness Meditation vs Headache ...

The primary outcome was change in migraine day frequency (baseline to 12 weeks). Secondary outcomes were changes in disability, quality of life ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06690060

Mind Body Intervention for Chronic Migraine Headaches

A score of ≥ 50 on the Headache Impact Test-6 self-report survey (moderate impact) 92. Presence of migraine headaches at least 5 days per month. Willing to ...

3.

neuro.jmir.org

neuro.jmir.org/2025/1/e68369

Experiences of a Neurofeedback-Based Mindfulness ...

Results: Participants spoke to 3 categories of experiences: the positive impact of neurofeedback-based mindfulness meditation on migraine ...

4.

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 ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S2049080122006227

Systematic Review / Meta-analysis Efficacy of mindfulness ...

Compared to usual care, MBSR/MBCT was not associated with a statistically significant improvement in Headache duration (MD = -0.27; 95% CI -3.51 to 2.97; P = ...

6.

withpower.com

withpower.com/trial/phase-chronic-pain-10-2024-bfadd

Mind-Body Intervention for Migraines

Research suggests that mind-body treatments can reduce the frequency of migraines by 35-50%, similar to medication but with fewer side effects. Progressive ...

7.

neurology.org

neurology.org/doi/10.1212/01.wnl.0000314667.16386.5e

Mind–body interventions: Applications in neurology

Mind–body therapies for other neurology applications have limited evidence due mostly to small clinical trials and inadequate control groups.

8.

neuro.jmir.org

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

Experiences of a Neurofeedback-Based Mindfulness ...

Participants reported that this neurofeedback-based mindfulness meditation intervention improved migraine management, leading to significant ...