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?

The goal of this exploratory study is to test a mind-body interventional approach for the treatment of chronic migraines. The main goal is to obtain feasibility information on the protocol which has been used in other similar conditions. We will also evaluate multiple measurement tools in order to optimize a follow-up pilot study evaluating the impact of the protocol on migraines.

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.

Is the mind-body intervention for migraines safe for humans?

Mind-body interventions, like mindfulness-based stress reduction, have been studied for migraines and other conditions. While most studies focus on effectiveness, a systematic review in children found that adverse events (unwanted effects) are rarely reported, but when they are, they are usually not severe. This suggests that mind-body interventions are generally safe, but more detailed safety data is needed. ^{1 2 3 4 5}

How is the Mind-Body Intervention treatment for migraines different from other treatments?

The Mind-Body Intervention for migraines is unique because it focuses on non-drug approaches like mindfulness and progressive muscle relaxation, which aim to improve attention and emotional regulation, rather than relying on medications. This approach can be particularly beneficial for those who cannot tolerate or afford traditional drug treatments. ^{1 2 6 7 8}

What data supports the effectiveness of the Mind-Body Intervention treatment 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 muscle relaxation, a component of mind-body interventions, has shown success in headache relief when combined with other behavioral strategies. ^{2 9 10 11 12}

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

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]

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]

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]

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]

Citations

1. England 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. [2020]

2. Australia pubmed.ncbi.nlm.nih.gov

Why does migraine improve during a clinical trial? Further results from a trial of cervical manipulation for migraine. [2019]

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

Mind/Body and behavioral treatments: the evidence and approach. [2012]

4. Sweden pubmed.ncbi.nlm.nih.gov

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

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

Multimodal biofeedback in the treatment of migraine. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Mindfulness in migraine: A narrative review. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Adverse Events of Mind-Body Interventions in Children: A Systematic Review. [2021]

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

Nocebo in headaches: implications for clinical practice and trial design. [2021]

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

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

10. India pubmed.ncbi.nlm.nih.gov

Behavioural management of migraine. [2021]

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

Behavioral and mind/body interventions in headache: unanswered questions and future research directions. [2014]

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

Bowenwork for Migraine Relief: a Case Report. [2023]