Recruiting

Behavioral Intervention

Sponsor:

Mayo Clinic

Code:

NCT05415020

Conditions

Migraine

Headache

Migraine Disorders

Chronic Migraine

Lifestyle Factors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Lifestyle Behavior Protocol

Sham Behavior Protocol

Study Details

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.

Conditions

Migraine

Headache

Migraine Disorders

Chronic Migraine

Lifestyle Factors

Study ID

NCT05415020

Start date

Jun 29, 2022

Status verified date

Jun, 2026

Completion date

Jul 31, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Virtual Therapy Group

sham comparator: Attention Placebo Group

Interventions

Lifestyle Behavior Protocol

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

Sham Behavior Protocol

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

Primary outcome measure

  • Number of Interested Participants that are Enrolled [ Time Frame: 12 weeks ]
  • Acceptability [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Dr. Yohannes W. Woldeamanuel, MD

650-933-3560Woldeamanuel.YohannesWoubishet@mayo.edu

Migraine Study

480-342-1385azmigrainetrial@mayo.edu

Locations

Mayo Clinic

Recruiting

Phoenix, Arizona, United States, 85054

Contacts

Dakota Hohenwalter

480-574-1416hohenwalter.dakota@mayo.edu

More Information

Sponsor

Mayo Clinic

Last update posted

Jun 8, 2026

Last verified

Jun, 2026

Keywords

  • Migraine Disorders
  • Headache
  • Lifestyle

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-06-08.