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Not yet recruitingNCT06170281SMARTMigUpdated Jun 16, 2026

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

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

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Migraine
  • Headache
  • Chronic Migraine
  • Headache Disorders

Keywords

  • migraine
  • headache
  • behavioral intervention
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • secondary headache disorders
  • children younger than 18 years old
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
24 participants (estimated)

Study arms

  • Active comparator
    Random - ME

    participants will be randomized to an intervention involving regular mealtime and regular timed exercise

    Behavioral: Migraine Behavioral Treatment

  • Active comparator
    Random - MS

    participants will be randomized to an intervention involving regular mealtime and regular sleep

    Behavioral: Migraine Behavioral Treatment

  • Active comparator
    Random - SE

    participants will be randomized to an intervention involving regular sleep and regular timed exercise

    Behavioral: Migraine Behavioral Treatment

  • Active comparator
    Choice - ME

    this arm belongs to participants who choose the intervention involving regular mealtime and regular timed exercise

    Behavioral: Migraine Behavioral Treatment

  • Active comparator
    Choice - MS

    this arm belongs to participants who choose the intervention involving regular mealtime and regular sleep

    Behavioral: Migraine Behavioral Treatment

  • Active comparator
    Choice - SE

    this arm belongs to participants who choose the intervention involving regular sleep and regular timed exercise

    Behavioral: Migraine Behavioral Treatment

Interventions

  • BehavioralMigraine Behavioral Treatment

    Migraine Behavioral Treatment involving daily activities

05

What researchers measure

Primary outcomes

  1. Feasibility in terms of recruitment and adherence rates

    recruitment rate, adherence rate

    Time frame: 12 weeks

Secondary outcomes

  1. 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

  2. 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

  3. 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

06

Study locations

1 site
07

References and documents

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. PubMed 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. PubMed 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. PubMed 34357593 ↗

Individual participant data

Plan to share: Yes — all IPD that underlie results in a publication

Supporting information: Study protocol, Sap

08

Registry details

Key details

Study ID
NCT06170281
Lead sponsor
Mayo Clinic
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Responsible party
Yohannes Woubishet Woldeamanuel (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Dec 14, 2023
Start date
Dec 2026 (estimated)
Primary completion
Jul 1, 2028 (estimated)
Completion
Dec 1, 2028 (estimated)
Last update
Jun 16, 2026

Study contacts

Yohannes W. Woldeamanuel, MD
Contact
Woldeamanuel.YohannesWoubishet@mayo.edu
480-342-1385
Yohannes W. Woldeamanuel, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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