Behavioral Treatment for Migraines

(SMARTMig Trial)

Overseen By Banu Rajasekaran, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Secondary headache disorders, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how specific behaviors like regular mealtimes, sleep, and exercise affect people with chronic migraines. Researchers aim to identify the best combination of these routines to reduce migraine symptoms. Participants will either choose their routine or receive a random assignment. This trial suits those who have experienced chronic migraines for at least a year and wish to try a non-medication approach, known as Migraine Behavioral Treatment, to manage their condition. As an unphased trial, it offers participants a unique opportunity to contribute to innovative research that could lead to new, non-medication strategies for managing chronic migraines.

Do I need to stop my current medications for the migraine trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this behavioral treatment is safe for migraines?

Research has shown that treatments like Cognitive Behavioral Therapy (CBT), relaxation training, and mindfulness are generally safe for adults with migraines. These methods reduce migraine frequency, with few side effects reported. Studies indicate that patients experience fewer headaches and improvements in daily life. These therapies also emphasize regular routines, such as consistent mealtimes, exercise, and sleep. Overall, they are well-tolerated and have a strong safety record for managing migraines. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these migraine treatment approaches because they focus on lifestyle adjustments rather than medication. Traditional migraine treatments often involve medications like triptans, NSAIDs, or preventive drugs, which can have side effects. Unlike these, the behavioral treatments in this trial emphasize regular mealtime, sleep, and timed exercise, which are non-invasive and aim to establish a stable routine that might reduce migraine frequency and severity. By addressing lifestyle factors, this approach could offer a holistic alternative with fewer side effects, making it appealing to those seeking natural methods to manage migraines.

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

This trial will evaluate different behavioral treatments for migraines, including interventions involving regular mealtime, sleep, and timed exercise. Research has shown that behavioral treatments can effectively reduce migraine headaches. Specifically, studies have found that Cognitive Behavioral Therapy (CBT), a form of behavioral treatment, significantly lowers the frequency and severity of headaches. CBT also improves the Migraine Disability Assessment (MIDAS) score, which measures the impact of migraines on daily life. Other methods, such as relaxation training and mindfulness, also help reduce migraine frequency. These treatments work by helping individuals develop better stress-coping strategies, which is crucial for managing migraines. Overall, behavioral treatments have shown promising results with few side effects. ^{2 3 6 7 8}

Who Is on the Research Team?

Yohannes W Woldeamanuel, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for adults who have been experiencing chronic migraines for at least one year. It's designed to find the best combination of behavioral treatments.

Inclusion Criteria

I have had chronic migraines for at least 1 year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive migraine behavioral treatment options, either by choice or randomization, for 6 weeks

6 weeks

All interventions delivered virtually

Re-assessment and Continuation

Participants are assessed for migraine frequency; responders continue in their original arms, non-responders are re-assigned

6 weeks

All interventions delivered virtually

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Migraine Behavioral Treatment

Trial Overview The study explores various behavioral interventions for managing migraines, examining which combinations work best and how personal preferences affect outcomes.

How Is the Trial Designed?

Group I: Choice - ME Active Control 1 Intervention

this arm belongs to participants who choose the intervention involving regular mealtime and regular timed exercise

Group II: Random - ME Active Control 1 Intervention

participants will be randomized to an intervention involving regular mealtime and regular timed exercise

Group III: Random - MS Active Control 1 Intervention

participants will be randomized to an intervention involving regular mealtime and regular sleep

Group IV: Random - SE Active Control 1 Intervention

participants will be randomized to an intervention involving regular sleep and regular timed exercise

Group V: Choice - MS Active Control 1 Intervention

this arm belongs to participants who choose the intervention involving regular mealtime and regular sleep

Group VI: Choice - SE Active Control 1 Intervention

this arm belongs to participants who choose the intervention involving regular sleep and regular timed exercise

Migraine Behavioral Treatment is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Migraine Behavioral Treatment for:

• Migraine prevention
• Migraine management

Approved in European Union as Behavioural Migraine Therapy for:

• Migraine prophylaxis
• Chronic migraine management

Approved in Canada as Cognitive Behavioral Therapy for Migraine for:

• Migraine prevention
• Headache management

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Published Research Related to This Trial

Behavioral treatments for migraines, including biofeedback and relaxation techniques, can reduce migraine frequency by 35-45%, with effect sizes ranging from 0.4 to 0.6, indicating moderate efficacy.

Cognitive-behavioral treatment, when used as part of a multimodal approach, improves migraine activity by an average of 39% and can be effectively combined with pharmacological treatments for enhanced results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Psychological therapy of migraine: systematic review]. Fritsche, G., Kröner-Herwig, B., Kropp, P., et al.[2021]

A home-based behavioral management training (BMT) for migraine, conducted by lay trainers, showed that participants maintained significant reductions in headache frequency and increased self-efficacy for up to four years after the training, based on data from 127 participants.

Quality of life and migraine-related disability improved over time, suggesting that this approach could provide long-term benefits for migraine patients, although further research is needed to confirm these findings due to the lack of a control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term follow-up of home-based behavioral management training provided by migraine patients. Voerman, JS., Klerk, Cd., Mérelle, SY., et al.[2022]

Cognitive behavioral therapy and biobehavioral training (like biofeedback and relaxation training) are effective behavioral approaches for managing migraines, especially when practiced correctly.

These behavioral techniques can be used alone or alongside medications, and they also emphasize the importance of patient education and support in improving treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral medicine for migraine. Buse, DC., Andrasik, F.[2018]

Telephone-based motivational interviewing (MI) significantly increased the likelihood of patients initiating behavioral therapy for migraine, with 68.8% of the MI group starting therapy compared to 40.7% in the treatment as usual (TAU) group.

Despite the improvement in initiation rates, MI did not affect the scheduling or attendance of therapy appointments, indicating that other barriers such as time constraints and insurance issues still hinder access to treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Randomized Controlled Trial to Assess the Impact of Motivational Interviewing on Initiating Behavioral Therapy for Migraine. Minen, MT., Sahyoun, G., Gopal, A., et al.[2021]

Behavioral treatments, such as patient education, relaxation techniques, biofeedback, and cognitive behavioral strategies, are effective in preventing migraine episodes and can be integrated into a stepped care approach for migraine management.

Incorporating these behavioral strategies at various levels of care can enhance overall treatment effectiveness for individuals suffering from migraines, addressing both the frequency of attacks and their impact on daily life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral treatments for migraine management: useful at each step of migraine care. Singer, AB., Buse, DC., Seng, EK.[2022]

A study of 401 participants with migraines found that most preferred in-person or smartphone-based behavioral therapies for migraine prevention, rather than telephone-based options.

Despite the effectiveness of these therapies, many participants were not willing to pay out of pocket for them, indicating a need for insurance coverage to increase utilization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral Therapy Preferences in People With Migraine. Minen, MT., Jalloh, A., Begasse de Dhaem, O., et al.[2021]

Psychological and behavioral treatments, such as biofeedback, relaxation, and stress-coping strategies, have been shown to be effective for the majority of migraine sufferers, with benefits lasting for at least one year.

There is limited understanding of how these psychological treatments work, highlighting the need for future research to explore their mechanisms and improve their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological treatments for migraine. Reid, GJ., McGrath, PJ.[2009]

Behavioral treatments for migraine have gained significant research attention over the past 25 years, focusing on their effectiveness compared to other treatments and how they can work alongside medications.

Current studies are exploring various aspects of behavioral treatments, including cost-effective delivery models and the long-term maintenance of treatment effects, which are crucial for improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral management of migraine. Andrasik, F.[2007]

In a study of 401 individuals with migraines, different ways of presenting information (message framing) did not significantly affect their willingness to seek behavioral treatments for migraine prevention.

Despite behavioral treatments being safe and effective, only 12.5% of participants had previously used such therapies, indicating a need for better strategies to encourage their use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Message Framing and the Willingness to Pursue Behavioral Therapy: A Study of People With Migraine. Jalloh, A., Begasse de Dhaem, O., Seng, E., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8777662/

Cognitive Behavioral Therapy for Migraine Headache CBT for migraine effectively reduced headache frequency and MIDAS score in meta-analysis and headache intensity subgroup analysis, with few adverse events.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35056352/

Cognitive Behavioral Therapy for Migraine Headache CBT for migraine effectively reduced headache frequency and MIDAS score in meta-analysis and headache intensity subgroup analysis, with few adverse events.

3. headachejournal.onlinelibrary.wiley.com headachejournal.onlinelibrary.wiley.com/doi/10.1111/head.14914

Behavioral interventions for migraine prevention: A systematic ... Results suggest that for adults, CBT, relaxation training, and mindfulness-based therapies may each reduce the frequency of migraine/headache ...

4. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2022.852616/full

Efficacy of Cognitive-Behavioral Therapy for the ... The miCBT has no better treatment effects compared to RLX in migraine-prophylaxis. Both treatments effectively increase patients' self-efficacy.

5. ihs-headache.org ihs-headache.org/wp-content/uploads/2020/06/McGrath.pdf

◗Psychological and Behavioral Treatments of Migraines Over the past three decades, several widely used behavioral interventions for migraine headache have been shown to be effective (1–6).

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39968795/

Behavioral interventions for migraine prevention Results suggest that for adults, CBT, relaxation training, and mindfulness-based therapies may each reduce the frequency of migraine/headache attacks.

7. va.gov va.gov/PAINMANAGEMENT/CBT_CP/docs/CBT-HA_BOOK_061621_complete_508.pdf

Cognitive Behavioral Therapy for Headache Diseases For migraine and TTH, research shows that people who combine behavioral treatments with medication have the best treatment outcomes compared to using one ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05889624

Responding With Evidence and Access for Childhood ... This comparative effectiveness study will clarify current first-line preventive treatment approaches for use by neurologists, psychologists, ...