Mindfulness Therapy for Migraines

(TEAM-M Trial)

Recruiting at 3 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether mindfulness therapy can help people with migraines. It compares three methods: over the phone, through video, and an online program called Mindfulness-Based Cognitive Therapy (MBCT). The researchers seek participants who experience migraines at least four days a month and have had them for over a year. Participants must be comfortable with English and able to use a headache diary regularly. The study aims to determine if these mindfulness techniques can reduce migraine pain and improve quality of life. As an unphased trial, it offers a unique opportunity to explore innovative mindfulness methods that could enhance well-being.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Mindfulness-Based Cognitive Therapy (MBCT) for migraines is generally safe and well-tolerated. Studies on MBCT delivered over the phone have found it practical and acceptable, with no major safety issues. One study noted its potential to reduce symptoms of depression, indicating positive mental health benefits.

For MBCT delivered via video, research has shown it to be a safe option that can effectively reduce headaches. Participants in these studies did not report any major side effects, making it a reliable choice for those interested in non-drug treatments.

Enhanced Usual Care (EUC), involving online modules, has also been found safe. While it may not improve all migraine-related symptoms, it helps reduce headache frequency without significant side effects.

Overall, these therapies are non-invasive, and existing studies support their safety for people looking to manage migraines. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about mindfulness therapy for migraines because it offers a convenient and accessible way to manage migraine symptoms. Unlike traditional treatments that often rely on medication, this approach uses mindfulness-based cognitive therapy (MBCT) to teach patients how to manage stress and pain through mental techniques. The therapy is delivered through online, telephone, and video formats, making it easy for participants to access from home without needing to visit a clinic. This flexibility and focus on mental health strategies could provide a valuable alternative or complement to existing migraine medications, potentially reducing dependency on drugs and empowering patients to take control of their symptoms.

What evidence suggests that this trial's treatments could be effective for migraines?

Studies have shown that Mindfulness-Based Cognitive Therapy (MBCT) can reduce the frequency of headaches in people with migraines. In this trial, participants may receive MBCT via video, which research indicates effectively lowers the impact of headaches on daily life. Another group will receive MBCT over the phone, which has shown evidence of reducing depression in individuals with long-term health issues, potentially benefiting those with migraines. Additionally, some participants will receive online MBCT programs, which have been found to lessen pain and stress-related symptoms. Overall, MBCT shows promise for easing migraine symptoms through these various delivery methods. ^{1 5 6 7 8}

Who Is on the 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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

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]

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]

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]

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 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]

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34932202/

Mindfulness-Based Cognitive Therapy as Migraine ... The migraine-specific MBCT program did not result in improvements with regard to headache-related impairment but showed a reduction in headache frequency.

2. 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… This study showed that people with migraine who received MBCT tailored for migraine (MBCT-M) had statistically significant reductions in ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6788949/

Does Mindfulness-Based Cognitive Therapy for Migraine ... The current phase 2b study aimed to evaluate the efficacy of MBCT-M to reduce migraine-related disability in people with migraine.

4. brieflands.com brieflands.com/articles/ans-58028

Effectiveness of Mindfulness-Based Cognitive-Behavioral ... This study aimed to evaluate the effectiveness of mindfulness-based cognitive therapy (MBCT) on reducing the impact of migraine headaches on women. Methods: In ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT07033520

Effects of Online Mindfulness Therapy on Pain and Stress ... This study aims to evaluate the effectiveness of an online Mindfulness-Based Cognitive Therapy (MBCT) program in reducing pain, stress-related symptoms, ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2049080122006227

Systematic Review / Meta-analysis Efficacy of mindfulness ... This review aims to assess the impact of MBSR/MBCT in alleviating the symptoms of chronic headaches.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9525407/

Mindfulness-Based Cognitive Therapy as Migraine ... The migraine-specific MBCT program did not result in improvements with regard to headache-related impairment but showed a reduction in headache frequency.

8. headachejournal.onlinelibrary.wiley.com headachejournal.onlinelibrary.wiley.com/doi/10.1111/head.14857

Feasibility, acceptability, and fidelity of remote‐delivered ... Mindfulness may be able to help people with migraine and low mood feel better, so we tested whether a group-based mindfulness treatment ...