Determining the Utility of a Behavioral Intervention in Chronic Migraine

Not Applicable

Recruiting

• Conditions: Migraine Disorders; Chronic Migraine; Headache Disorders; Migraine; Headache; Lifestyle Factors
• Interventions: Behavioral: Lifestyle Behavior Protocol; Behavioral: Sham Behavior Protocol

• Registration Number: NCT05415020
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-08
• Study First Submitted QC: 2022-06-08
• Study First Posted: 2022-06-10
• Study Start: 2022-06-29
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-14
• Last Update Posted: 2025-02-18
• Primary Completion: 2026-07-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual Therapy Group	Lifestyle Behavior Protocol	-
Attention Placebo Group	Sham Behavior Protocol	-

Primary Outcome Measures

Name	Time	Method
Feasibility	12 weeks	Recruitment rate
Acceptability	12 weeks	Retention rate

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Phoenix, Arizona, United States