An interventional study of Lifestyle Behavior Protocol and Sham Behavior Protocol in Migraine, Headache and Migraine Disorders, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-08.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Treatment
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.
1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.
This study's planned enrollment of 60 is below the median of 80 across 1,269 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Behavioral: Lifestyle Behavior Protocol
Behavioral: Sham Behavior Protocol
Virtual training on building a skillset to improve lifestyle behavior that reduces migraine attacks
Virtual training on the disease of migraine and how migraine can progress to chronic migraine.
Number of Interested Participants that are Enrolled
Recruitment rate (Feasibility Outcome)
Time frame: 12 weeks
Acceptability
Retention rate
Time frame: 12 weeks
Mean change from baseline monthly migraine frequency
Change in the mean of monthly migraine frequency
Time frame: 12 weeks
Migraine severity
severity of migraine attacks rated from 0 to 10
Time frame: 12 weeks
Headache self-efficacy
Headache self-efficacy measured using the validated Headache Self-Efficacy Questionnaire. Scores range from 25 to 175. Higher scores mean a better outcome.
Time frame: 12 weeks
Levels of candidate biomarkers
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)
Time frame: 12 weeks
Plan to share: Yes — all IPD that underlie results in a publication
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: starting 6 months after publication, for 5 years
Access criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.