Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06170281

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Chronic Migraine Headache Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Migraine Behavioral Treatment

Behavioral

Migraine Behavioral Treatment involving daily activities

Primary outcomes

  1. Feasibility in terms of recruitment and adherence rates

    Time frame: 12 weeks

    recruitment rate, adherence rate

Secondary outcomes

  1. Migraine Frequency

    Time frame: at baseline 4 weeks before randomization, week 2-6 after date of randomization, week 8-12 after date of randomization

    migraine day frequency

  2. Headache Self-efficacy

    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 measured using validated headache self-efficacy questionnaire

  3. Migraine Intensity

    Time frame: at baseline 4 weeks before randomization, week 2-6 after date of randomization, week 8-12 after date of randomization

    migraine intensity, self-reported

Study contacts

Contact information is provided by the study sponsor or research team.

Yohannes W. Woldeamanuel, MD

CONTACT

[email protected]

480-342-1385

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Official study title

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

Acronym: SMARTMig

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Dec 14, 2023
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.