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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether changing behaviors can help people with chronic migraines feel better. Participants may receive classes on Empowered Relief (a behavioral intervention), Health Education, or both, to determine if these approaches reduce migraine-related disability and symptoms. The study occurs online, eliminating the need for in-person visits. It is ideal for individuals diagnosed with chronic migraines by a neurologist and who experience frequent headaches. Participants should also have internet access for online sessions.

As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve migraine management.

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 prior data suggests that these behavioral interventions are safe for treating chronic migraine?

Research shows that both the Empowered Relief and Health Education methods are safe and well-received by participants. Studies have found that Empowered Relief effectively reduces pain-related stress without serious side effects. Participants often feel less worried about their pain and sleep better one month after the session.

Previous studies have also proven Health Education safe. About 34% of participants experienced a significant decrease in headache frequency after three months, with no major negative effects reported.

When combined, Empowered Relief and Health Education show similarly positive results. Research indicates that this combination can maintain improved outcomes for up to six months, again without significant safety concerns. Overall, both treatments have a strong safety record, making them promising options for people with chronic migraines. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Behavioral Interventions for Chronic Migraine trial because it explores non-drug approaches that empower patients. Unlike traditional migraine treatments, which often rely on medications like triptans or preventive drugs such as beta-blockers, these interventions focus on behavioral changes. The Empowered Relief (ER) class helps patients manage their migraines by teaching them to track symptoms and triggers through daily diaries, promoting self-awareness and proactive management. The Health Education (HE) class aims to educate participants on lifestyle modifications that can alleviate migraine frequency and severity. Combining these methods could offer a holistic and sustainable way to reduce migraines without medication side effects.

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

Studies have shown that the Empowered Relief program, one of the treatments in this trial, can significantly reduce feelings of being overwhelmed by pain by about 42% after three months. Participants reported feeling less helpless about their pain following the program. Similarly, Health Education programs, another treatment option in this trial, have decreased the frequency of headaches in about 34% of participants after three months. This trial will also explore combining Empowered Relief with Health Education, which might enhance these benefits further. Empowered Relief has proven to be at least as effective as Cognitive Behavioral Therapy, a well-known treatment, and often more effective than Health Education alone. Overall, these programs have shown promise in reducing the impact and severity of chronic migraines. ^{1 2 5 6 7}

Who Is on the Research Team?

John Sturgeon, PhD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10824382/

Empowered Relief, cognitive behavioral therapy, and ... Results extend to 6 months post-treatment previous findings documenting that ER and CBT exhibit similarly potent effects on outcomes. 1.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8463950/

Efficacy of a Single-Session “Empowered Relief” Zoom- ... At 3 months, clinically meaningful pain catastrophizing scale (PCS) reductions were found for ER but not for WLC (ER: PCS −8.72, 42.25% reduction; WLC: PCS − ...

3. withpower.com withpower.com/trial/phase-migraine-disorders-7-2023-2a56f

Behavioral Interventions for Chronic Migraine Trial Overview The study examines if behavior changes through 'Empowered Relief' or 'Health Education' interventions reduce migraine-related disability and ...

4. pcori.org pcori.org/research-results/2021/comparing-effectiveness-two-online-programs-treating-chronic-pain

Comparing the Effectiveness of Two Online Programs for ... The project compares the effectiveness of two different online programs for treating chronic pain. Who will this research inform?

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2783047

Comparison of a Single-Session Pain Management Skills ... Our results suggest that empowered relief can achieve similar results across key outcomes at 3 months. We underscore that empowered relief ...

6. journals.lww.com journals.lww.com/painrpts/fulltext/2024/01000/empowered_relief,_cognitive_behavioral_therapy,.5.aspx

Empowered Relief, cognitive behavioral therapy, and ... Empowered Relief remained non-inferior to CBT on most outcomes, whereas both ER and CBT remained superior to HE on most outcomes.

7. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05303-8

Comparative efficacy of a single-session “Empowered Relief ... Pilot data revealed significantly reduced pain-specific distress—as indexed by reductions in pain catastrophizing—1 month post-treatment, ...