Headache outcomes of a sleep behavioral intervention in breast cancer survivors: Secondary analysis of a randomized clinical trial.
Yohannes W Woldeamanuel, Douglas W Blayney, Booil Jo...
https://pubmed.ncbi.nlm.nih.gov/34357593Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID05415020
Feasibility, Acceptability, and Pilot Testing of a Behavioral Intervention for Chronic Migraine
Led by Mayo Clinic · Updated on 2026-06-08
60
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
M
Mayo Clinic
Lead Sponsor
N
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a lifestyle behavior protocol to manage chronic migraine. This pilot study aims to assess how feasible and acceptable this behavioral approach is for patients and to explore unique biomolecules in those who respond to the treatment. The results will help design a larger future behavioral clinical trial focused on controlling chronic migraine. Participants are randomly assigned to one of two groups: a Virtual Therapy Group receiving training to improve lifestyle behaviors that may reduce migraine attacks, or an Attention Placebo Group receiving education about migraine and its progression. Both groups receive virtual training over a 12-week period to compare outcomes. During the study, researchers will monitor participation rates and acceptability of the intervention. They will also measure changes in monthly migraine frequency and migraine severity over 12 weeks. The study lasts for at least 12 weeks, with assessments focused on how well participants engage with the treatment and any changes in their migraine symptoms.
CONDITIONS
Brief Title
Determining the Utility of a Behavioral Intervention in Chronic Migraine
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Have chronic migraine for a minimum of 1 year
- Aged 18 years and older
You will not qualify if you...
- Have other headache disorders, including secondary headache disorders
- Younger than 18 years old
- Currently pregnant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (virtual or in-person)
Treatment
Duration - 12 weeks
Participants receive virtual behavioral training to either improve lifestyle behaviors that reduce migraine attacks or learn about migraine progression, depending on their group assignment.
Weekly virtual sessions for 12 weeks
Trial Site Locations
Total: 1 location
1
Mayo Clinic
Phoenix, Arizona, United States, 85054
Actively Recruiting
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Research Team
D
Dr. Yohannes W. Woldeamanuel, MD
M
Migraine Study
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Endogenous glucocorticoids may serve as biomarkers for migraine chronification.
Yohannes W Woldeamanuel, Bharati M Sanjanwala, Robert P Cowan
https://pubmed.ncbi.nlm.nih.gov/32973989Exploring Natural Clusters of Chronic Migraine Phenotypes: A Cross-Sectional Clinical Study.
Yohannes W Woldeamanuel, Bharati M Sanjanwala, Addie M Peretz...
https://pubmed.ncbi.nlm.nih.gov/32071349Clinical Features Contributing to Cortical Thickness Changes in Chronic Migraine - A Pilot Study.
Yohannes W Woldeamanuel, Danielle D DeSouza, Bharati M Sanjanwala...
https://pubmed.ncbi.nlm.nih.gov/30468246Migraine affects 1 in 10 people worldwide featuring recent rise: A systematic review and meta-analysis of community-based studies involving 6 million participants.
Yohannes W Woldeamanuel, Robert P Cowan
https://pubmed.ncbi.nlm.nih.gov/28017235The impact of regular lifestyle behavior in migraine: a prevalence case-referent study.
Yohannes W Woldeamanuel, Robert P Cowan
https://pubmed.ncbi.nlm.nih.gov/26810728