An interventional study of Migraine Behavioral Treatment in Migraine, Headache and Chronic Migraine, sponsored by Mayo Clinic. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-16.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Treatment
This study will unpack the behavioral intervention for migraine and determine the optimum combinations. In addition, the study will test preference and self-selection effects during the trial.
After a 4-week screening period, eligible candidates (14 headache days in 4 week period, with 8 days being migraine) will be randomized into 2 arms -
After 6 weeks, all participants will be assessed for their migraine frequency. Patients will be considered Responders if the migraine frequency is reduced to 50%. The Non-responders (NR) of the Choice Arm will be again given a chance to pick any of the 3 arms. The NR of the randomized arm will be randomized to any of the 3 arms. The responders will continue for 6 more weeks in their original arms. By the end of the 12 weeks, all participants will complete the study, and migraine frequency will be compared between the different groups. All behavioral interventions will be delivered virtually.
1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.
This study's planned enrollment of 24 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:
participants will be randomized to an intervention involving regular mealtime and regular timed exercise
Behavioral: Migraine Behavioral Treatment
participants will be randomized to an intervention involving regular mealtime and regular sleep
Behavioral: Migraine Behavioral Treatment
participants will be randomized to an intervention involving regular sleep and regular timed exercise
Behavioral: Migraine Behavioral Treatment
this arm belongs to participants who choose the intervention involving regular mealtime and regular timed exercise
Behavioral: Migraine Behavioral Treatment
this arm belongs to participants who choose the intervention involving regular mealtime and regular sleep
Behavioral: Migraine Behavioral Treatment
this arm belongs to participants who choose the intervention involving regular sleep and regular timed exercise
Behavioral: Migraine Behavioral Treatment
Migraine Behavioral Treatment involving daily activities
Feasibility in terms of recruitment and adherence rates
recruitment rate, adherence rate
Time frame: 12 weeks
Migraine Frequency
migraine day frequency
Time frame: at baseline 4 weeks before randomization, week 2-6 after date of randomization, week 8-12 after date of randomization
Headache Self-efficacy
headache self-efficacy measured using validated headache self-efficacy questionnaire
Time frame: at baseline 4 weeks before randomization, week 2-6 after date of randomization, week 8-12 after date of randomization
Migraine Intensity
migraine intensity, self-reported
Time frame: at baseline 4 weeks before randomization, week 2-6 after date of randomization, week 8-12 after date of randomization
Plan to share: Yes — all IPD that underlie results in a publication
Supporting information: Study protocol, Statistical analysis plan
Time frame: starting 6 months after publication, for 2 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).
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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