Determining the Utility of a Behavioral Intervention in Chronic Migraine

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05415020

Acronym

RLB

Enrollment

Registered

2022-06-10

Start date

2022-06-29

Completion date

2027-07-31

Last updated

2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Migraine, Headache, Headache Disorders, Lifestyle Factors, Migraine, Migraine Disorders

Keywords

Migraine Disorders, Headache, Lifestyle

Brief summary

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.

Interventions

BEHAVIORALLifestyle Behavior Protocol

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

BEHAVIORALSham Behavior Protocol

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Number of Interested Participants that are Enrolled	12 weeks	Recruitment rate (Feasibility Outcome)
Acceptability	12 weeks	Retention rate

Secondary

Measure	Time frame	Description
Mean change from baseline monthly migraine frequency	12 weeks	Change in the mean of monthly migraine frequency
Migraine severity	12 weeks	severity of migraine attacks rated from 0 to 10

Countries

United States

Contacts

CONTACTDr. Yohannes W. Woldeamanuel, MD

Woldeamanuel.YohannesWoubishet@mayo.edu650-933-3560

CONTACTMigraine Study

azmigrainetrial@mayo.edu480-342-1385

PRINCIPAL_INVESTIGATORDr. Yohannes W. Woldeamanuel, MD

Mayo Clinic

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 9, 2026