Behavioral Intervention for Chronic Migraine

(RLB Trial)

Recruiting at 1 trial location

Overseen By Migraine Study

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Other headache disorders, pregnancy, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a lifestyle behavior program designed to help people manage chronic migraines. Researchers aim to determine if this approach is practical, well-received, and effective in reducing migraine symptoms. The trial will also explore changes in certain molecules in the body in response to this treatment. Participants will be divided into two groups: one receiving virtual therapy (Lifestyle Behavior Protocol) and the other a placebo (an inactive treatment for comparison). Individuals who have experienced chronic migraines for at least a year might be a good fit. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve migraine management for many.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to ask the trial organizers for more details.

What prior data suggests that this lifestyle behavior protocol is safe for managing chronic migraine?

Research shows that lifestyle changes, such as improving sleep habits and using relaxation techniques, can help manage migraines. Studies have found that these changes might reduce headache frequency. These methods, which focus on everyday habits like sleep and exercise, are already in use and are generally safe. No reports of serious side effects have emerged from these lifestyle changes. Participants can feel confident that this approach is safe and well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Behavioral Intervention for Chronic Migraine trial because it explores a non-drug approach to managing migraines, which could offer a new pathway for patients who prefer or require alternatives to medication. Unlike traditional treatments that often rely on pharmaceuticals like triptans or beta-blockers, this trial uses a Lifestyle Behavior Protocol delivered through virtual therapy sessions. This approach could empower patients by focusing on lifestyle changes and behavioral strategies, potentially reducing reliance on medications and minimizing side effects. Additionally, by using virtual therapy, this method increases accessibility, making it easier for individuals to participate and benefit from the intervention without the need for in-person visits.

What evidence suggests that this lifestyle behavior protocol is effective for managing chronic migraine?

Research shows that lifestyle changes can help manage chronic migraines. In this trial, participants in the Virtual Therapy Group will receive a Lifestyle Behavior Protocol, which includes strategies such as improving sleep, regular exercise, and stress management to reduce migraine frequency. Studies have found that these lifestyle changes can significantly impact migraine occurrence. Meanwhile, the Attention Placebo Group will receive a Sham Behavior Protocol. Treatments like cognitive behavioral therapy (CBT) have improved the quality of life for people with migraines, and this trial aims to use these methods to potentially transform chronic migraines into less frequent, occasional ones. ^{1 3 4 6 7}

Who Is on the Research Team?

Dr. Yohannes W. Woldeamanuel, MD

Principal Investigator

Mayo Clinic

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 not suitable for individuals with other types of headaches, those under 18, or pregnant women.

Inclusion Criteria

I have had chronic migraines for at least 1 year.

I have had chronic migraines for at least 1 year.

Exclusion Criteria

Current pregnancy

I am under 18 years old.

I have been diagnosed with a headache disorder other than migraines.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a lifestyle behavior protocol to manage chronic migraine

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Lifestyle Behavior Protocol
• Sham Behavior Protocol

Trial Overview The study is testing a lifestyle behavior protocol designed to manage chronic migraines and will compare it against a sham (placebo) protocol. The trial also aims to identify specific biomolecules related to the condition.

How Is the Trial Designed?

Group I: Virtual Therapy Group Active Control 1 Intervention

Group II: Attention Placebo Group Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

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 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]

Traditional medical training often focuses on an expert approach, which is less effective for managing chronic diseases compared to a coaching approach that empowers patients to reflect on their motivations and obstacles for behavior change.

The coaching approach involves active collaboration between practitioners and patients, utilizing techniques like mindful listening and open-ended questions, which can lead to better self-discovery and responsibility in achieving healthier habits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collaboration and Negotiation: The Key to Therapeutic Lifestyle Change. Frates, EP., Bonnet, J.[2023]

The LINDA intervention, which provided individualized lifestyle counseling to 1,537 young women over 1.5-2.5 years, resulted in a 37% improvement in health behaviors related to physical activity, meal regularity, and sleep compared to 31% in the control group.

Participants who received targeted support for physical activity and sleep showed significant improvements, with 30% increasing their activity levels and 36% going to bed earlier, indicating the effectiveness of personalized counseling in promoting healthier lifestyles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

LINDA - a solution-focused low-intensity intervention aimed at improving health behaviors of young females: a cluster-randomized controlled trial. Valve, P., Lehtinen-Jacks, S., Eriksson, T., et al.[2021]

Many people struggle to follow dietary and exercise recommendations, indicating that current lifestyle counseling may not be effectively reaching its goals, despite being considered essential in medical care.

Research suggests that both conscious and automatic psychosocial processes can support behavior change, and there is growing evidence that automated processes may enhance the effectiveness of lifestyle interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How to help patients adopt and maintain a healthy lifestyle? A review of behavioral evidence of determinants and means. Absetz, P., Hankonen, N.[2018]

The patient-centered counseling model improves long-term dietary adherence by personalizing interventions based on individual patient needs and stages of change.

This model includes a 4-step counseling process that helps nutrition professionals effectively support patients in following nutrition care plans and dietary guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Facilitating dietary change: the patient-centered counseling model. Rosal, MC., Ebbeling, CB., Lofgren, I., et al.[2022]

Weight loss of just 5-10% can significantly improve health issues related to obesity, such as hypertension and type II diabetes, as shown in studies like the Diabetes Prevention Program, which found a 7% weight reduction reduced diabetes risk by 58%.

Behavioral treatments, which include diet changes, increased physical activity, and behavior therapy, are effective in achieving and maintaining this level of weight loss, promoting long-term health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle modification in the treatment of obesity: an educational challenge and opportunity. Jones, LR., Wilson, CI., Wadden, TA.[2007]

Behavioral counseling can significantly enhance adherence to healthy lifestyle changes, which is crucial for reaping the associated health benefits.

Understanding individual motivation and resistance to change is essential for effective counseling, and established models like motivational interviewing and the transtheoretical model can be applied to encourage increased physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of Counseling to Promote Adherence in Healthy Lifestyle Medicine: Strategies to Improve Exercise Adherence and Enhance Physical Activity. Stonerock, GL., Blumenthal, JA.[2023]

After 6 months of home-based behavioral training (BT) led by lay trainers, 42% of participants experienced a significant reduction in migraine attack frequency, with an overall decrease from 3.0 attacks to 2.3 attacks per month, indicating the efficacy of this self-management approach.

Participants reported improved quality of life and maintained feelings of control and self-confidence in managing their migraines, suggesting that BT not only helps reduce attack frequency but also enhances patients' overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lay trainers with migraine for a home-based behavioral training: a 6-month follow-up study. Mérelle, SY., Sorbi, MJ., van Doornen, LJ., et al.[2019]

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]

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]

The DASH Mobile system is designed to help hypertensive patients adopt the DASH diet, which emphasizes fruits, vegetables, low-fat dairy, and lean protein, while also promoting physical activity and reducing sodium intake.

This mobile health (mHealth) app aims to make it easier for users to track their diet and health metrics, potentially overcoming the challenges of traditional in-person interventions and improving patient engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of DASH Mobile: a mHealth lifestyle change intervention for the management of hypertension. Mann, DM., Kudesia, V., Reddy, S., et al.[2013]

The DASH trial demonstrated that with careful participant selection and a structured orientation, adherence to a controlled feeding study can be successfully achieved, as evidenced by excellent adherence rates documented through various methods.

Participants reported that lack of menu variety was a common reason for lapses in adherence, highlighting the importance of providing diverse food options to maintain compliance in dietary studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary adherence in the Dietary Approaches to Stop Hypertension trial. DASH Collaborative Research Group. Windhauser, MM., Evans, MA., McCullough, ML., et al.[2019]

Behavioral interventions have been shown to effectively improve health outcomes for chronic illness management, as indicated by biomedical measures.

Current interventions are often too expensive and time-consuming for widespread use, highlighting the need for new, efficient cognitive-behavioral strategies that integrate self-management concepts and innovative clinical trial designs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health Psychology: the Search for Pathways between Behavior and Health. Leventhal, H., Weinman, J., Leventhal, EA., et al.[2022]

In a randomized controlled trial with 368 participants, online behavioral training (BT) did not significantly reduce migraine attack frequency compared to a waitlist control group, with both groups experiencing a similar 20-25% decrease.

However, participants who completed the BT showed significant improvements in migraine-related self-efficacy and developed a more internal locus of control, suggesting that while BT may not reduce attack frequency, it can enhance participants' confidence and management of their condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term effectiveness of an online behavioral training in migraine self-management: a randomized controlled trial. Kleiboer, A., Sorbi, M., van Silfhout, M., et al.[2014]

Citations

1. ccjm.org ccjm.org/content/86/11/741

SEEDS for success: Lifestyle management in migraine Behavioral modification for sleep hygiene can convert chronic migraine to episodic migraine. One such program is stimulus control therapy ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8971279/

Lifestyle Modifications for Migraine Management - PMC We reviewed the current and available data on the role of a healthy lifestyle in the management of migraine. Physical activity, management of ...

3. mayo.edu mayo.edu/research/clinical-trials/cls-20583645

Clinical Trials This proposal will involve a pilot study to evaluate the feasibility, acceptability, and outcomes of a lifestyle behavior protocol in managing ...

4. withpower.com withpower.com/trial/phase-lifestyle-factors-5-2022-43d5d?condition=Headache&overallStatus=Recruiting&hasNoPlacebo=false

Behavioral Intervention for Chronic Migraine (RLB Trial) This proposal will involve a pilot study to evaluate the feasibility, acceptability, and outcomes of a lifestyle behavior protocol in managing chronic migraine.

5. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK608525/

Results - Behavioral Interventions for Migraine Prevention Meta-analysis of CBT, adults, migraine-specific quality of life. For Intervention: B – Biofeedback; CBT – Cognitive behavioral therapy; E – Education; MBSR – ...

6. 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 ...

7. clinicaltrials.stanford.edu clinicaltrials.stanford.edu/trials/d/NCT05415020.html

Determining the Utility of a Behavioral Intervention in Chronic ... This proposal will involve a pilot study to evaluate the feasibility, acceptability, and outcomes of a lifestyle behavior protocol in managing chronic migraine.