Mindfulness Therapy for Migraines

(TEAM-M Trial)

Recruiting at 2 trial locations

Overseen By Devyn Gaskins

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Amanda Shallcross

Must not be taking: Antidepressants

Disqualifiers: Psychiatric illness, Cognitive impairment, others

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

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

144 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a type of therapy called Mindfulness-Based Cognitive Therapy, provided over the phone, through video calls, or as part of regular care with added support. It aims to help people with migraines and depressive symptoms by teaching them to focus on the present moment and understand their thought patterns better. Mindfulness-Based Cognitive Therapy (MBCT) was developed to prevent relapse in recurrent depression by combining cognitive behavioral therapy and meditative techniques.

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

The trial requires you to maintain stable dosages of your current acute or preventive medications for the study duration. If you've recently changed your migraine or antidepressant medications, you may not be eligible.

What data supports the idea that Mindfulness Therapy for Migraines is an effective treatment?

The available research shows that Mindfulness Therapy for Migraines can effectively reduce migraine-related disability. Studies have demonstrated that this treatment can help people with both episodic and chronic migraines. It has been shown to improve how people think about their pain, which can lead to less suffering. Additionally, the benefits of this therapy can last over time, making it a promising option for managing migraine pain. ^{1 2 3 4 5}

What safety data exists for mindfulness therapy for migraines?

The available research on mindfulness-based cognitive therapy (MBCT) for migraines primarily focuses on its efficacy and feasibility rather than specific safety data. The studies reviewed include pilot trials and randomized controlled trials, which suggest potential benefits in reducing migraine-related disability and improving psychological well-being. However, these studies do not explicitly address safety concerns, indicating a need for further research to evaluate safety aspects comprehensively. ^{1 2 3 6 7}

Is Mindfulness-Based Cognitive Therapy a promising treatment for migraines?

Yes, Mindfulness-Based Cognitive Therapy (MBCT) is a promising treatment for migraines. Studies show it can help reduce migraine-related disability and improve how people handle pain. It has been adapted specifically for migraines and can be delivered online, by phone, or through video, making it accessible to more people. ^{1 2 3 4 8}

Research Team

Elizabeth K Seng, Ph.D.

Principal Investigator

Albert Einstein College of Medicine and Yeshiva University

Amanda J Shallcross, M.P.H., N.D.

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

This trial is for adults over 18 who have migraines 4-14 days a month and mild to moderate depression. They must meet specific migraine criteria, be able to read/speak English, consent to participate, and keep a headache diary. Excluded are those with certain psychiatric conditions, recent changes in migraine or antidepressant medications, prior mindfulness therapy experience, daily meditation practice, or unstable medication use.

Inclusion Criteria

Score between 5-14 on the PHQ-9

Currently meets ICHD-3 criteria for migraine using the American Migraine Prevalence and Prevention Diagnostic Module

I have had migraines for over a year.

Exclusion Criteria

I started a new migraine treatment less than 4 weeks ago.

Meeting ICHD-3 criteria for persistent headache attributed to traumatic injury to the head (post-traumatic headache) on the American Migraine Prevalence and Prevention Diagnostic Module

I haven't changed my migraine prevention plan in the last 3 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Mindfulness-Based Cognitive Therapy (MBCT) via telephone, video, or Enhanced Usual Care (EUC) over 8 weeks

8 weeks

8 weekly sessions (telephone/video/online)

Follow-up

Participants are monitored for changes in depressive symptoms and migraine-specific quality of life

3 months

Treatment Details

Interventions

• Online
• Telephone
• Video

Trial Overview The study tests Mindfulness-Based Cognitive Therapy (MBCT) for treating migraines and mood issues. It's delivered in three ways: by phone calls (Telephone), video sessions (Video), or through online education modules (Online). Participants will be randomly assigned to one of these methods.

Participant Groups

Group I: MBCT-Telephone Active Control 1 Intervention

8 weekly classes delivered via telephone.

Group II: Enhanced Usual Care (EUC) Active Control 1 Intervention

8 weekly online modules delivered via web portal.

Group III: MBCT-Video Active Control 1 Intervention

8 weekly classes delivered via video.

Who Is Running the Clinical Trial?

Amanda Shallcross

Lead Sponsor

Trials

2

Recruited

220+

Albert Einstein College of Medicine

Lead Sponsor

Trials

302

Recruited

11,690,000+

Wake Forest University Health Sciences

Collaborator

Trials

1,432

Recruited

2,506,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Yeshiva University

Collaborator

Trials

13

Recruited

2,600+

The Cleveland Clinic

Collaborator

Trials

1,072

Recruited

1,377,000+

Findings from Research

The Phase 2b study involving 60 participants showed that mindfulness-based cognitive therapy for migraine (MBCT-M) significantly reduced headache-related disability, with a notable decrease in the headache disability inventory (HDI) scores in the MBCT-M group compared to the waitlist group.

MBCT-M also effectively decreased attack-level migraine-related disability, as indicated by improvements in the Migraine Disability Index (MIDI), suggesting it is a promising treatment option for individuals suffering from migraines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Mindfulness-Based Cognitive Therapy for Migraine Reduce Migraine-Related Disability in People with Episodic and Chronic Migraine? A Phase 2b Pilot Randomized Clinical Trial. Seng, EK., Singer, AB., Metts, C., et al.[2023]

The migraine-specific adaptation of Mindfulness-Based Cognitive Therapy (MBCT) did not significantly improve headache-related impairment but led to a notable reduction in headache frequency among 54 participants, indicating some effectiveness in managing migraines.

Participants reported improvements in psychological factors such as perceived stress and anxiety, with the intervention being feasible and well-received, suggesting that MBCT can enhance overall psychological functioning in individuals with migraines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Cognitive Therapy as Migraine Intervention: a Randomized Waitlist Controlled Trial. Simshäuser, K., Pohl, R., Behrens, P., et al.[2022]

In a study of 60 adults with migraines, those who underwent 8 weeks of mindfulness-based cognitive therapy for migraine (MBCT-M) showed a significant reduction in pain catastrophizing compared to a waitlist group, indicating the therapy's efficacy in addressing negative pain perceptions.

While pain catastrophizing decreased significantly, cognitive fusion did not show a notable change, suggesting that the reduction in pain-related distress may be a key mechanism through which MBCT-M improves migraine-related disability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in cognitive appraisal in a randomized controlled trial of mindfulness-based cognitive therapy for patients with migraine. Kruse, JA., Seng, EK.[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]

An 8-week Mindfulness-Based Cognitive Therapy (MBCT) program significantly reduced headache pain intensity and interference, with these improvements maintained for 6 months after treatment in a study of 19 participants.

Participants also showed lasting benefits in pain catastrophizing, activity engagement, and self-efficacy, indicating that MBCT can provide durable relief from headache pain and improve related psychological factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive therapy for headache pain: An evaluation of the long-term maintenance of effects. Day, MA., Thorn, BE.[2018]

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 online behavioral training (oBT) for migraine self-management significantly improved self-efficacy and quality of life for participants, indicating its effectiveness in empowering individuals to manage their migraines better.

While both the oBT group and the waitlist control group experienced a reduction in migraine attack frequency, the oBT group showed unique benefits in self-management skills and quality of life, suggesting that the training may foster active engagement in managing migraines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medium-term effectiveness of online behavioral training in migraine self-management: A randomized trial controlled over 10 months. Sorbi, MJ., Kleiboer, AM., van Silfhout, HG., et al.[2015]

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]

References

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

Does Mindfulness-Based Cognitive Therapy for Migraine Reduce Migraine-Related Disability in People with Episodic and Chronic Migraine? A Phase 2b Pilot Randomized Clinical Trial. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Cognitive Therapy as Migraine Intervention: a Randomized Waitlist Controlled Trial. [2022]

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

Changes in cognitive appraisal in a randomized controlled trial of mindfulness-based cognitive therapy for patients with migraine. [2023]

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

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

5. Scotland pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive therapy for headache pain: An evaluation of the long-term maintenance of effects. [2018]

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

Mindfulness in migraine: A narrative review. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Medium-term effectiveness of online behavioral training in migraine self-management: A randomized trial controlled over 10 months. [2015]

8. Sweden pubmed.ncbi.nlm.nih.gov

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