BridgeMD
New treatment option for Migraine
Official title BE WELL With Migraine: Brain Education and WELLness With Migraine
ClinicalTrials.gov ID: NCT05987592
What this study is testing
- What it's testing
- The goal of this randomized clinical trial is to evaluate two different non-drug, virtual treatment options designed to improve the lives of patients with migraine. Both interventions involve 8 weekly sessions and an online platform with additional content and learning.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Diagnosis of migraine with or without aura by with headache frequency of 4-20 days/month
- At least 1 year of migraine
- At least 18 years old
- Able to participate in 8 weekly online classes
- Willingness to complete baseline headache logs
You likely can't join if
- Major unstable medical/psychiatric condition that could be unsafe for participants or for the group environment.
- Medication overuse headache, with migraine treatment
- Pregnant women who are more than 16 weeks gestation at enrollment
- Unstable migraine treatment at enrollment: any preventive treatment (oral or injectable medication or neuromodulatory device) started within 12 weeks...
- Unwillingness to maintain stable current medication dosages for study duration
- Failure to complete baseline headache logs
See the full eligibility criteria
- Diagnosis of migraine with or without aura by with headache frequency of 4-20 days/month
- At least 1 year of migraine
- At least 18 years old
- Able to participate in 8 weekly online classes
- Willingness to complete baseline headache logs
- Headache-related disability (Headache Impact Test (HIT)-6) score \>50
- Fluent in English
- Completion of technology onboarding with the online platform
- Pregnant women who are less than or equal to 16 weeks gestation at enrollment are allowed to participate
- Major unstable medical/psychiatric condition that could be unsafe for participants or for the group environment.
- Medication overuse headache, with migraine treatment
- Pregnant women who are more than 16 weeks gestation at enrollment
- Unstable migraine treatment at enrollment: any preventive treatment (oral or injectable medication or neuromodulatory device) started within 12 weeks OR acute treatment within 4 weeks to ensure stability
- Unwillingness to maintain stable current medication dosages for study duration
- Failure to complete baseline headache logs
- Heavy alcohol and illicit drug use
- Participation in another intervention clinical trial or one that would interfere in this study
- Experience with stress reduction training (daily meditation practice, regular use of a mindfulness app, or prior experience with MBSR)
- Any, and all other diagnoses or conditions which, in the opinion of the site investigator, would prevent the patient from being a suitable candidate for the study or interfere with the medical care needs of the study...
The study team makes the final eligibility decision.
Where it's taking place
- Cambridge, Massachusetts, United States
- Winston-Salem, North Carolina, United States
- Cincinnati, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cambridge, Massachusetts, United States; Winston-Salem, North Carolina, United States; Cincinnati, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.