MigraineSMARTMigNCT06170281
Sequential, Multiple Assignment, Double Randomized Preference, Migraine Behavioral Trial
A study testing Migraine Behavioral Treatment in people with Migraine and Headache, run by Mayo Clinic at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine, Headache, Chronic Migraine
- What is being tested?
- Migraine Behavioral Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- have chronic migraine for a minimum of 1-year
- aged 18 years and older
Who cannot join
- secondary headache disorders
- children younger than 18 years old
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Mayo Clinic
Phoenix, Arizona, 85054
Yohannes W. Woldeamanuel, MD, 480-342-1385, Woldeamanuel.YohannesWoubishet@mayo.edu
About this study
Official title: A Feasibility Clinical Trial Assessing Patient Preference, Optimum Combinations and Sequences of a Multicomponent, Virtually-Delivered Migraine Behavioral Intervention
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.
- Conditions
- Migraine, Headache, Chronic Migraine, Headache Disorders
- Being tested
- Migraine Behavioral Treatment
- Keywords
- migraine, headache, behavioral intervention
- Medical subject headings
- Migraine Disorders, Headache, Headache Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Migraine Behavioral TreatmentBehavioural
Migraine Behavioral Treatment involving daily activities
| Study group | Role | What they receive |
|---|---|---|
| Random - ME | Active comparator | participants will be randomized to an intervention involving regular mealtime and regular timed exercise Receives: Behavioral: Migraine Behavioral Treatment |
| Random - MS | Active comparator | participants will be randomized to an intervention involving regular mealtime and regular sleep Receives: Behavioral: Migraine Behavioral Treatment |
| Random - SE | Active comparator | participants will be randomized to an intervention involving regular sleep and regular timed exercise Receives: Behavioral: Migraine Behavioral Treatment |
| Choice - ME | Active comparator | this arm belongs to participants who choose the intervention involving regular mealtime and regular timed exercise Receives: Behavioral: Migraine Behavioral Treatment |
| Choice - MS | Active comparator | this arm belongs to participants who choose the intervention involving regular mealtime and regular sleep Receives: Behavioral: Migraine Behavioral Treatment |
| Choice - SE | Active comparator | this arm belongs to participants who choose the intervention involving regular sleep and regular timed exercise Receives: Behavioral: Migraine Behavioral Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility in terms of recruitment and adherence rates
recruitment rate, adherence rate
Measured: 12 weeks
Secondary outcomes (3)
Migraine Frequency
migraine day frequency
Measured: 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
Measured: 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
Measured: at baseline 4 weeks before randomization, week 2-6 after date of randomization, week 8-12 after date of randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study startDec 2026 (estimated)
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Principal investigator, Yohannes Woubishet Woldeamanuel, Mayo Clinic
- Investigators
- Yohannes W. Woldeamanuel, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06170281
- Sponsor's protocol ID
- 24-006447
- Other IDs
- K01NS124911
- Acronym
- SMARTMig
- Status last verified
- Jun 2026
- First submitted
- 6 Oct 2023
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
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 32071349Woldeamanuel 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 26810728Woldeamanuel 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Clinical Trial Assessing Patient Preference, Optimum Combinations and Sequences of a Multicomponent, Virtually-Delivered Migraine Behavioral Intervention
- ClinicalTrials.gov ID
- NCT06170281
- Acronym / sponsor ID
- SMARTMig / 24-006447
- Conditions
- Migraine, Headache, Chronic Migraine, Headache Disorders
- Keywords
- migraine, headache, behavioral intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Dec 2026 (estimated)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 14 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Random - ME | Active comparator | Behavioral: Migraine Behavioral Treatmentparticipants will be randomized to an intervention involving regular mealtime and regular timed exercise |
| Random - MS | Active comparator | Behavioral: Migraine Behavioral Treatmentparticipants will be randomized to an intervention involving regular mealtime and regular sleep |
| Random - SE | Active comparator | Behavioral: Migraine Behavioral Treatmentparticipants will be randomized to an intervention involving regular sleep and regular timed exercise |
| Choice - ME | Active comparator | Behavioral: Migraine Behavioral Treatmentthis arm belongs to participants who choose the intervention involving regular mealtime and regular timed exercise |
| Choice - MS | Active comparator | Behavioral: Migraine Behavioral Treatmentthis arm belongs to participants who choose the intervention involving regular mealtime and regular sleep |
| Choice - SE | Active comparator | Behavioral: Migraine Behavioral Treatmentthis arm belongs to participants who choose the intervention involving regular sleep and regular timed exercise |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- have chronic migraine for a minimum of 1-year
- aged 18 years and older
Key exclusion criteria (2 listed)
- secondary headache disorders
- children younger than 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Migraine Behavioral TreatmentMigraine Behavioral Treatment involving daily activities | Behavioural | Choice - ME, Choice - MS, Choice - SE, Random - ME, Random - MS, Random - SE |
Primary outcome
Feasibility in terms of recruitment and adherence rates
Time frame: 12 weeks
recruitment rate, adherence rate
3 secondary outcomes
Migraine 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
Time frame: at baseline 4 weeks before randomization, week 2-6 after date of randomization, week 8-12 after date of randomization
Migraine Intensity
Time frame: at baseline 4 weeks before randomization, week 2-6 after date of randomization, week 8-12 after date of randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Background: PubMed 32071349Woldeamanuel 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.
- Background: PubMed 26810728Woldeamanuel 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.
- Background: PubMed 34357593Woldeamanuel 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.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yohannes W. Woldeamanuel, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Migraine Behavioral Treatment in people with Migraine and Headache, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yohannes W. Woldeamanuel, MD (480-342-1385, Woldeamanuel.YohannesWoubishet@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility in terms of recruitment and adherence rates (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06170281, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.