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

Trial Summary

What is the purpose of this trial?

This study will unpack the behavioral intervention for migraine and determine the optimum combinations. In addition, the study will test preference and self-selection effects during the trial.

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 data supports the effectiveness of the treatment Migraine Behavioral Treatment for migraines?

Research shows that behavioral treatments like cognitive behavioral therapy, biofeedback, and relaxation techniques can reduce migraine frequency by 35-45% and improve migraine activity by 39%. These treatments are effective for most migraine sufferers and can be used alone or with medication for better results. ^{1 2 3 4 5}

Is behavioral treatment for migraines safe for humans?

Behavioral treatments for migraines, such as biofeedback, cognitive behavioral therapy, and relaxation, are considered safe and well-tolerated according to research. ^{1 2 6 7 8}

How is Migraine Behavioral Treatment different from other migraine treatments?

Migraine Behavioral Treatment is unique because it focuses on changing behaviors to prevent migraines, using techniques like relaxation, biofeedback, and cognitive behavioral therapy (a type of talk therapy that helps change negative thought patterns). Unlike medications, this treatment can be used alone or alongside drugs, and it has shown similar success rates in reducing migraine frequency. ^{1 2 5 8 9}

Research Team

Yohannes W Woldeamanuel, MD

Principal Investigator

Stanford University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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 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]

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]

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]

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]

References

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

Behavioral treatments for migraine management: useful at each step of migraine care. [2022]

2. France pubmed.ncbi.nlm.nih.gov

Behavioral management of migraine. [2007]

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

Behavioral medicine for migraine. [2018]

4. France pubmed.ncbi.nlm.nih.gov

Psychological treatments for migraine. [2009]

5. Germany pubmed.ncbi.nlm.nih.gov

[Psychological therapy of migraine: systematic review]. [2021]

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

Behavioral Therapy Preferences in People With Migraine. [2021]

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

Message Framing and the Willingness to Pursue Behavioral Therapy: A Study of People With Migraine. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Long-term follow-up of home-based behavioral management training provided by migraine patients. [2022]

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

A Pilot Randomized Controlled Trial to Assess the Impact of Motivational Interviewing on Initiating Behavioral Therapy for Migraine. [2021]