Determining the Utility of a Behavioral Intervention in Chronic Migraine (RLB)

Mayo Clinic

Status: Enrolling

Conditions: Headache Disorders; Migraine Disorders; Chronic Migraine; Lifestyle Factors; Migraine; Headache

Treatments: Behavioral: Sham Behavior Protocol; Behavioral: Lifestyle Behavior Protocol

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05415020

K01NS124911 (U.S. NIH Grant/Contract)

24-004888

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Virtual Therapy Group

Active Comparator group

Treatment:

Behavioral: Lifestyle Behavior Protocol

Attention Placebo Group

Sham Comparator group

Treatment:

Behavioral: Sham Behavior Protocol