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NCT Number: NCT05415020

Determining the Utility of a Behavioral Intervention in Chronic Migraine

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.

Recruiting

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Chronic Migraine Headache Headache Disorders Headache Disorders, Primary Lifestyle Factors Migraine Disorders Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Phoenix, Arizona, 85054, United States

Location status: Recruiting

Location contact

Dakota Hohenwalter

CONTACT

[email protected]

480-574-1416

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • have chronic migraine for a minimum of 1-year
  • aged 18 years and older

Exclusion criteria

  • other headache disorders including secondary headache disorders
  • children younger than 18 years old
  • current pregnancy

Treatment and study plan

Lifestyle Behavior Protocol

Behavioral

Virtual training on building a skillset to improve lifestyle behavior that reduces migraine attacks

Sham Behavior Protocol

Behavioral

Virtual training on the disease of migraine and how migraine can progress to chronic migraine.

Primary outcomes

  1. Number of Interested Participants that are Enrolled

    Time frame: 12 weeks

    Recruitment rate (Feasibility Outcome)

  2. Acceptability

    Time frame: 12 weeks

    Retention rate

Secondary outcomes

  1. Mean change from baseline monthly migraine frequency

    Time frame: 12 weeks

    Change in the mean of monthly migraine frequency

  2. Migraine severity

    Time frame: 12 weeks

    severity of migraine attacks rated from 0 to 10

Other outcomes

  1. Headache self-efficacy

    Time frame: 12 weeks

    Headache self-efficacy measured using the validated Headache Self-Efficacy Questionnaire. Scores range from 25 to 175. Higher scores mean a better outcome.

  2. Levels of candidate biomarkers

    Time frame: 12 weeks

    Using mass spectrometry, serum levels of candidate biomarkers acryloyl-CoA, glutaminylhistidine, HABP2 will be compared at baseline and end of study (end of week-12)

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. Yohannes W. Woldeamanuel, MD

CONTACT

[email protected]

650-933-3560

Migraine Study

CONTACT

[email protected]

480-342-1385

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Official study title

Feasibility, Acceptability, and Pilot Testing of a Behavioral Intervention for Chronic Migraine

Acronym: RLB

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Jun 10, 2022
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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