Behavioral Interventions for Chronic Migraine

Overseen By Courtni Minghine-Beemer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Cognitive impairment, Litigation, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 1 month

300 Participants Needed

Trial Summary

What is the purpose of this trial?

People with chronic migraine headaches face many challenges, including high levels of daily pain, disturbances to everyday activities and sleep, and problems with mood such as depression or anxiety. This trial is being completed to study whether changing an individual's behaviors may have an impact as a treatment for migraine headaches. Eligible participants will be randomized to one of the four arms. This study will be conducted remotely without in-person contact. Study Hypothesis: * There is a main effect of attending either the Empowered Relief and Health Education intervention on reductions in migraine-related disability 1 month after completing either intervention * There is a main effect of Empowered Relief and Health Education interventions on reducing pain-related catastrophizing and migraine symptom severity 1 month after completing either intervention (secondary hypothesis) * The expected reductions in migraine-related disability, pain catastrophizing, and migraine symptom severity will be maintained at secondary time points (2 months, 3 months, and 6 months after completing either intervention) (secondary hypothesis)

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 focuses on behavioral interventions for chronic migraine.

What data supports the effectiveness of the treatment Empowered Relief for chronic migraine?

Research shows that patient education, a key component of Empowered Relief, can improve self-confidence and management of headaches, leading to better outcomes. Education has been linked to reduced headache frequency and increased self-efficacy, which means patients feel more in control of their condition. ^{1 2 3 4 5}

Is behavioral therapy for migraine safe?

There are safe and well-tolerated behavioral therapies for preventing migraines, such as biofeedback, cognitive behavioral therapy, and relaxation. ^{2 4 5 6 7}

How is the Empowered Relief treatment for chronic migraine different from other treatments?

Empowered Relief is a behavioral treatment that focuses on educating patients about their condition and teaching them skills to manage it, which is different from traditional drug treatments. It emphasizes patient awareness and lifestyle changes to reduce migraine frequency and severity, often integrating with other therapies for comprehensive care. ^{8 9 10 11 12}

Research Team

John Sturgeon, PhD

Principal Investigator

University of Michigan

Eligibility Criteria

This trial is for individuals with a neurologist's diagnosis of chronic migraine, who meet specific criteria and can communicate in English. They must have internet access for remote participation. People currently in cognitive therapy for pain or involved in medical litigation, or those unable to consent due to cognitive issues are excluded.

Inclusion Criteria

Meets diagnostic criteria for chronic migraine according to the Identify Chronic Migraine (IDCM) self-reported instrument

I have been diagnosed with chronic migraine by a neurologist.

English-speaking

Exclusion Criteria

Open litigation regarding a medical condition, as assessed in preliminary study screening

I am currently undergoing therapy for pain or migraine.

I am able to understand and agree to the study's requirements.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to one of four arms and receive either Empowered Relief, Health Education, both interventions, or Treatment as Usual. The interventions are conducted remotely.

1 month

Follow-up

Participants are monitored for reductions in migraine-related disability, pain catastrophizing, and migraine symptom severity at 2, 3, and 6 months after completing the intervention.

6 months

Treatment Details

Interventions

• Empowered Relief
• Health Education

Trial Overview The study examines if behavior changes through 'Empowered Relief' or 'Health Education' interventions reduce migraine-related disability and symptom severity. Participants will be randomly assigned to one of the groups and followed up remotely at various intervals after completing the intervention.

Participant Groups

Group I: Treatment as Usual (TAU) Experimental Treatment 1 Intervention

Group II: Health Education (HE) class Experimental Treatment 1 Intervention

Group III: Empowered Relief (ER) class and Health Education (HE) class Experimental Treatment 2 Interventions

If randomized to both classes, the HE class will occur first with a week break in between to the ER class.

Group IV: Empowered Relief (ER) class Experimental Treatment 1 Intervention

Daily Diaries

Empowered Relief is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Empowered Relief for:

• Chronic pain
• Acute pain
• Pain-related distress

Approved in European Union as Empowered Relief for:

• Chronic pain
• Acute pain
• Pain-related distress

Approved in Canada as Empowered Relief for:

• Chronic pain
• Acute pain
• Pain-related distress

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Findings from Research

Patient education significantly enhances self-efficacy and adherence to both nonpharmacological (like aerobic training and relaxation) and pharmacological therapies for headache management.

In moderately affected patients, education alone can lead to improvements, but for those with severe or chronic headaches, a multidisciplinary approach that includes education is more effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Headache: patient education as part of a multidisciplinary treatment. Are there reliable results?]. Gaul, C.[2016]

Recent advancements in migraine management have transformed treatment satisfaction, primarily through the development of a comprehensive 'treatment toolkit' that includes patient education and goal-setting between patients and clinicians.

This approach not only empowers patients to understand their condition and optimize treatment but also incorporates behavioral advice and appropriate medications, leading to improved outcomes and reduced headache-related disability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Building a migraine toolkit for patients: successful management of migraine headache. Schreiber, CP.[2009]

In a study involving 284 individuals with migraines, 46% reported a significant reduction in headache frequency (50% or greater) after participating in the Mercy Migraine Management Program (MMMP) over 12 months, indicating its effectiveness in managing migraines.

Participants also experienced improvements in headache-related disability, quality of life, self-efficacy, and satisfaction with care, particularly those who initially had higher levels of worry about their headaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Migraine education improves quality of life in a primary care setting. Smith, TR., Nicholson, RA., Banks, JW.[2021]

The Calgary Headache Assessment and Management Program's new-patient Education Session was well-received, with 87% of participants recommending it to others, indicating high satisfaction and perceived usefulness.

Patient feedback highlighted the importance of topics like medication management and understanding headache types, while also suggesting improvements in practical strategies for managing triggers, which can enhance the effectiveness of headache education programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Making a new-patient headache education session more patient-centered: what participants want to know. McLean, A., Becker, WJ., Vujadinovic, Z.[2021]

Home-based behavioral training (BT) led by lay trainers with migraine resulted in a minor reduction in attack frequency (21%) and clinically significant improvements in perceived control and self-confidence for 35% of participants in a study of 108 patients.

While the BT did not show a statistically significant difference in attack frequency compared to the waitlist-control group, it significantly enhanced patients' confidence in managing their migraines, particularly benefiting those with higher baseline attack frequencies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Migraine patients as trainers of their fellow patients in non-pharmacological preventive attack management: short-term effects of a randomized controlled trial. Mérelle, SY., Sorbi, MJ., van Doornen, LJ., et al.[2010]

A review of 73 migraine drug trials published between 2010 and 2015 found that while a majority reported adverse events, only 41% included this information in their abstracts, highlighting a gap in transparency.

The study emphasizes the need for all randomized controlled trials on migraine treatments to consistently report adverse events in their abstracts to better assess the safety and tolerability of these medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the reporting of adverse events in controlled clinical trials conducted in 2010-2015 on migraine drug treatments. Tfelt-Hansen, P., Lindqvist, JK., Do, TP.[2019]

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]

Behavioral treatments like relaxation, biofeedback, and cognitive behavioral therapy can help prevent episodic migraines from becoming chronic, reducing headache-related disability.

Integrating behavioral therapies with physical and pharmacological treatments provides the best outcomes for managing chronic migraines, as it empowers patients to understand and manage their condition effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral therapy for chronic migraine. Pistoia, F., Sacco, S., Carolei, A.[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]

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]

Behavioral interventions like biofeedback, relaxation training, and cognitive-behavioral stress management are effective treatments for migraine headaches, applicable in various formats such as clinic-based, limited-contact, and home-based settings.

The review highlights the integration of these behavioral treatments with pharmacotherapy and discusses their role in migraine treatment guidelines, emphasizing their efficacy for both adults and children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral approaches to the treatment of migraine. Holroyd, KA., Drew, JB.[2007]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Headache: patient education as part of a multidisciplinary treatment. Are there reliable results?]. [2016]

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

Building a migraine toolkit for patients: successful management of migraine headache. [2009]

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

Migraine education improves quality of life in a primary care setting. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Making a new-patient headache education session more patient-centered: what participants want to know. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Migraine patients as trainers of their fellow patients in non-pharmacological preventive attack management: short-term effects of a randomized controlled trial. [2010]

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

Evaluating the reporting of adverse events in controlled clinical trials conducted in 2010-2015 on migraine drug treatments. [2019]

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

Behavioral Therapy Preferences in People With Migraine. [2021]

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

Behavioral therapy for chronic migraine. [2021]

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

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

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

Behavioral medicine for migraine. [2018]

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

Behavioral approaches to the treatment of migraine. [2007]

12. England pubmed.ncbi.nlm.nih.gov

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