Behavioral Intervention for Chronic Migraine

(RLB Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Dr. Yohannes Woldeamanuel, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Mayo Clinic

Disqualifiers: Other headache disorders, pregnancy, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This proposal will involve a pilot study to evaluate the feasibility, acceptability, and outcomes of a lifestyle behavior protocol in managing chronic migraine. Additionally, the proposal will investigate biomolecules that are uniquely involved in chronic migraine patients who respond to the protocol. Successful completion of this proposal will inform the design of a future full-scale behavioral clinical trial to control chronic migraine.

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 data supports the effectiveness of this treatment for chronic migraine?

Research shows that lifestyle modifications, including diet, physical activity, and behavior therapy, can improve health outcomes in various conditions. Behavioral interventions have been effective in managing chronic illnesses, suggesting they might also help with chronic migraines by promoting healthier habits. ^{1 2 3 4 5}

Is the behavioral intervention for chronic migraine safe for humans?

The research on lifestyle and behavioral interventions, like those used for managing hypertension and promoting healthy habits, generally shows that these approaches are safe for humans. They focus on improving diet, physical activity, and other healthy behaviors without significant risks. ^{4 6 7 8 9}

How is the Lifestyle Behavior Protocol treatment for chronic migraine different from other treatments?

The Lifestyle Behavior Protocol is unique because it focuses on behavioral changes, like relaxation and cognitive strategies, to help patients recognize and manage factors that trigger migraines, rather than relying solely on medication. This approach empowers patients to improve their quality of life by adopting healthier habits and integrating these strategies with other treatments. ^{10 11 12 13 14}

Research Team

Dr. Yohannes Woldeamanuel, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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 am 18 years old or older.

I have had chronic migraines for at least 1 year.

I am 18 years old or older.

Exclusion Criteria

Current pregnancy

I am under 18 years old.

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

Trial Timeline

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

Treatment Details

Interventions

• Lifestyle Behavior Protocol (Behavioral Intervention)
• Sham Behavior Protocol (Behavioral Intervention)

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.

Participant Groups

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+

Dr. Gianrico Farrugia

Mayo Clinic

Chief Executive Officer since 2019

MD from University of Malta Medical School

Dr. Richard Afable

Mayo Clinic

Chief Medical Officer

MD from Loyola Stritch School of Medicine

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Dr. Richard A. Miller

Stanford University

Chief Executive Officer since 2023

Stanford University, MD

Dr. Robert Schott

Stanford University

Chief Medical Officer since 2021

University of Michigan, MD

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Jordan Gladman

National Institute of Neurological Disorders and Stroke (NINDS)

Chief Medical Officer

MD from Harvard Medical School

Walter J. Koroshetz

National Institute of Neurological Disorders and Stroke (NINDS)

Chief Executive Officer since 2007

MD from the University of Chicago

Findings from Research

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 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]

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]

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]

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 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]

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]

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]

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]

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]

References

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

Facilitating dietary change: the patient-centered counseling model. [2022]

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

Lifestyle modification in the treatment of obesity: an educational challenge and opportunity. [2007]

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

Health Psychology: the Search for Pathways between Behavior and Health. [2022]

4. England 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. [2021]

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

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

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

Collaboration and Negotiation: The Key to Therapeutic Lifestyle Change. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Development of DASH Mobile: a mHealth lifestyle change intervention for the management of hypertension. [2013]

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

Dietary adherence in the Dietary Approaches to Stop Hypertension trial. DASH Collaborative Research Group. [2019]

9. Finland pubmed.ncbi.nlm.nih.gov

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

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

Lay trainers with migraine for a home-based behavioral training: a 6-month follow-up study. [2019]

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

Behavioral therapy for chronic migraine. [2021]

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

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

13. England pubmed.ncbi.nlm.nih.gov

Short-term effectiveness of an online behavioral training in migraine self-management: a randomized controlled trial. [2014]

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

Behavioral approaches to the treatment of migraine. [2007]