MigraineRLBNCT05415020
Determining the Utility of a Behavioral Intervention in Chronic Migraine
A study testing Lifestyle Behavior Protocol in people with Migraine and Headache, run by Mayo Clinic at 1 site in United States.
Trial summary
This proposal will involve a pilot study to evaluate the feasibility, acceptability, and outcomes of a lifestyle behavior protocol in managing chronic migraine. Additionally, the proposal will investigate biomolecules that are uniquely involved in chronic migraine patients who respond to the protocol. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine, Headache, Migraine Disorders
- What is being tested?
- Lifestyle Behavior Protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2022to 31 Jul 2027
- 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
- other headache disorders including secondary headache disorders
- children younger than 18 years old
- current pregnancy
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, 1 recruiting
- Recruiting
Mayo Clinic
Phoenix, Arizona, 85054
Dakota Hohenwalter, 480-574-1416, hohenwalter.dakota@mayo.edu
About this study
Official title: Feasibility, Acceptability, and Pilot Testing of a Behavioral Intervention for Chronic Migraine
This proposal will involve a pilot study to evaluate the feasibility, acceptability, and outcomes of a lifestyle behavior protocol in managing chronic migraine. Additionally, the proposal will investigate biomolecules that are uniquely involved in chronic migraine patients who respond to the protocol. Successful completion of this proposal will inform the design of a future full-scale behavioral clinical trial to control chronic migraine.
- Conditions
- Migraine, Headache, Migraine Disorders, Chronic Migraine, Lifestyle Factors, Headache Disorders
- Being tested
- Lifestyle Behavior Protocol, Sham Behavior Protocol
- Keywords
- Migraine Disorders, Headache, Lifestyle
- 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.
Lifestyle Behavior ProtocolBehavioural
Virtual training on building a skillset to improve lifestyle behavior that reduces migraine attacks
Sham Behavior ProtocolBehavioural
Virtual training on the disease of migraine and how migraine can progress to chronic migraine.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Therapy Group | Active comparator | Not described Receives: Behavioral: Lifestyle Behavior Protocol |
| Attention Placebo Group | Sham comparator | Not described Receives: Behavioral: Sham Behavior Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Interested Participants that are Enrolled
Recruitment rate (Feasibility Outcome)
Measured: 12 weeks
Acceptability
Retention rate
Measured: 12 weeks
Secondary outcomes (2)
Mean change from baseline monthly migraine frequency
Change in the mean of monthly migraine frequency
Measured: 12 weeks
Migraine severity
severity of migraine attacks rated from 0 to 10
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start29 Jun 2022
- Primary completion31 May 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yohannes Woubishet Woldeamanuel, Mayo Clinic
- Investigators
- Dr. Yohannes W. Woldeamanuel, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05415020
- Sponsor's protocol ID
- 24-004888
- Other IDs
- K01NS124911
- Acronym
- RLB
- Status last verified
- Jun 2026
- First submitted
- 8 Jun 2022
- Last updated
- 8 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, 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 34357593Woldeamanuel YW, Sanjanwala BM, Cowan RP. Endogenous glucocorticoids may serve as biomarkers for migraine chronification. Ther Adv Chronic Dis. 2020 Jul 21;11:2040622320939793. doi: 10.1177/2040622320939793. eCollection 2020.
PubMed 32973989Woldeamanuel 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, DeSouza DD, Sanjanwala BM, Cowan RP. Clinical Features Contributing to Cortical Thickness Changes in Chronic Migraine - A Pilot Study. Headache. 2019 Feb;59(2):180-191. doi: 10.1111/head.13452. Epub 2018 Nov 23.
PubMed 30468246Woldeamanuel YW, Cowan RP. Migraine affects 1 in 10 people worldwide featuring recent rise: A systematic review and meta-analysis of community-based studies involving 6 million participants. J Neurol Sci. 2017 Jan 15;372:307-315. doi: 10.1016/j.jns.2016.11.071. Epub 2016 Dec 3.
PubMed 28017235Woldeamanuel 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Acceptability, and Pilot Testing of a Behavioral Intervention for Chronic Migraine
- ClinicalTrials.gov ID
- NCT05415020
- Acronym / sponsor ID
- RLB / 24-004888
- Conditions
- Migraine, Headache, Migraine Disorders, Chronic Migraine, Lifestyle Factors, Headache Disorders
- Keywords
- Migraine Disorders, Headache, Lifestyle
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 29 Jun 2022 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 10 Jun 2022 (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 proposal will involve a pilot study to evaluate the feasibility, acceptability, and outcomes of a lifestyle behavior protocol in managing chronic migraine. Additionally, the proposal will investigate biomolecules that are uniquely involved in chronic migraine patients who respond to the protocol. Successful completion of this proposal will inform the design of a future full-scale behavioral clinical trial to control chronic migraine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Therapy Group | Active comparator | Behavioral: Lifestyle Behavior Protocol |
| Attention Placebo Group | Sham comparator | Behavioral: Sham Behavior Protocol |
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 (3 listed)
- other headache disorders including secondary headache disorders
- children younger than 18 years old
- current pregnancy
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 |
|---|---|---|
| Lifestyle Behavior ProtocolVirtual training on building a skillset to improve lifestyle behavior that reduces migraine attacks | Behavioural | Virtual Therapy Group |
| Sham Behavior ProtocolVirtual training on the disease of migraine and how migraine can progress to chronic migraine. | Behavioural | Attention Placebo Group |
Primary outcome
Number of Interested Participants that are Enrolled
Time frame: 12 weeks
Recruitment rate (Feasibility Outcome)
Acceptability
Time frame: 12 weeks
Retention rate
2 secondary outcomes
Mean change from baseline monthly migraine frequency
Time frame: 12 weeks
Migraine severity
Time frame: 12 weeks
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 8 Jun 2026.
- 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.
- Background: PubMed 32973989Woldeamanuel YW, Sanjanwala BM, Cowan RP. Endogenous glucocorticoids may serve as biomarkers for migraine chronification. Ther Adv Chronic Dis. 2020 Jul 21;11:2040622320939793. doi: 10.1177/2040622320939793. eCollection 2020.
- 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 30468246Woldeamanuel YW, DeSouza DD, Sanjanwala BM, Cowan RP. Clinical Features Contributing to Cortical Thickness Changes in Chronic Migraine - A Pilot Study. Headache. 2019 Feb;59(2):180-191. doi: 10.1111/head.13452. Epub 2018 Nov 23.
- Background: PubMed 28017235Woldeamanuel YW, Cowan RP. Migraine affects 1 in 10 people worldwide featuring recent rise: A systematic review and meta-analysis of community-based studies involving 6 million participants. J Neurol Sci. 2017 Jan 15;372:307-315. doi: 10.1016/j.jns.2016.11.071. Epub 2016 Dec 3.
- 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.
- 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.
Dr. 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 Lifestyle Behavior Protocol 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 3 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: looking for participants now, as of the sponsor's last update on 8 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. Some participants in this study may receive a placebo. 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 Dr. Yohannes W. Woldeamanuel, MD (650-933-3560, Woldeamanuel.YohannesWoubishet@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Interested Participants that are Enrolled (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 NCT05415020, which also lists 6 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 8 Jun 2026.