Sequential, Multiple Assignment, Double Randomized Preference, Migraine Behavioral Trial

NCT06170281 — Not applicable, Not yet recruiting, 24 participants, Mayo Clinic

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A Feasibility Clinical Trial Assessing Patient Preference, Optimum Combinations and Sequences of a Multicomponent, Virtually-Delivered Migraine Behavioral Intervention

Registry	NCT06170281, acronym SMARTMig
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, sequential, masking: none, treatment
Enrollment	24 (Estimated)
Sponsor	Mayo Clinic (Other); collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
Conditions	Migraine, Headache, Chronic Migraine, Headache Disorders
Interventions	Migraine Behavioral Treatment (Behavioral)
Dates	start 2026-12-01 (estimated), primary completion 2028-07-01 (estimated), completion 2028-12-01 (estimated), first posted 2023-12-14, last updated 2026-06-16
Locations	1 site in United States

-Summary

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.

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+Detailed description

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 -

* Choice Arm: allowed to choose from a menu of migraine behavioral treatment options
* Random: randomized to migraine behavioral treatment options.

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.

+Arms and interventions

Arm	Type	Interventions	Description
Random - ME	Active comparator	Behavioral: Migraine Behavioral Treatment	participants will be randomized to an intervention involving regular mealtime and regular timed exercise
Random - MS	Active comparator	Behavioral: Migraine Behavioral Treatment	participants will be randomized to an intervention involving regular mealtime and regular sleep
Random - SE	Active comparator	Behavioral: Migraine Behavioral Treatment	participants will be randomized to an intervention involving regular sleep and regular timed exercise
Choice - ME	Active comparator	Behavioral: Migraine Behavioral Treatment	this arm belongs to participants who choose the intervention involving regular mealtime and regular timed exercise
Choice - MS	Active comparator	Behavioral: Migraine Behavioral Treatment	this arm belongs to participants who choose the intervention involving regular mealtime and regular sleep
Choice - SE	Active comparator	Behavioral: Migraine Behavioral Treatment	this arm belongs to participants who choose the intervention involving regular sleep and regular timed exercise

Migraine Behavioral Treatment (Behavioral): Migraine Behavioral Treatment involving daily activities

+Outcome measures

Primary outcomes

Feasibility in terms of recruitment and adherence rates [12 weeks]: recruitment rate, adherence rate

Secondary outcomes

Migraine Frequency [at baseline 4 weeks before randomization, week 2-6 after date of randomization, week 8-12 after date of randomization]: migraine day frequency
Headache Self-efficacy [at baseline 4 weeks before randomization, week 2-6 after date of randomization, week 8-12 after date of randomization]: headache self-efficacy measured using validated headache self-efficacy questionnaire
Migraine Intensity [at baseline 4 weeks before randomization, week 2-6 after date of randomization, week 8-12 after date of randomization]: migraine intensity, self-reported

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* have chronic migraine for a minimum of 1-year
* aged 18 years and older

Exclusion Criteria:

* secondary headache disorders
* children younger than 18 years old

+Locations (1)

Facility	City	Country	Status
Mayo Clinic	Phoenix, Arizona	United States

+Publications

Woldeamanuel YW, Sanjanwala BM, Peretz AM, Cowan RP. Exploring Natural Clusters of Chronic Migraine Phenotypes: A Cross-Sectional Clinical Study. Sci Rep. 2020 Feb 18;10(1):2804. doi: 10.1038/s41598-020-59738-1. PMID 32071349
Woldeamanuel YW, Cowan RP. The impact of regular lifestyle behavior in migraine: a prevalence case-referent study. J Neurol. 2016 Apr;263(4):669-76. doi: 10.1007/s00415-016-8031-5. Epub 2016 Jan 25. PMID 26810728
Woldeamanuel YW, Blayney DW, Jo B, Fisher SE, Benedict C, Oakley-Girvan I, Kesler SR, Palesh O. Headache outcomes of a sleep behavioral intervention in breast cancer survivors: Secondary analysis of a randomized clinical trial. Cancer. 2021 Dec 1;127(23):4492-4503. doi: 10.1002/cncr.33844. Epub 2021 Aug 6. PMID 34357593

+Investigators

Yohannes W. Woldeamanuel, MD, Principal investigator, Mayo Clinic

+Funding

NIH grants: K01NS124911