RightFit
RecruitingNot applicable

BE WELL With Migraine: Brain Education and WELLness With Migraine

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "All assessments and surveys will be completed virtually and/or online."
  • "Participants will keep an online daily headache log and complete several online surveys throughout the study."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests two online treatments without drugs to help people with migraine. It is for adults who have had migraine for at least 1 year and have headaches 4–20 days a month. Both treatments include 8 weekly sessions and extra online lessons, and people can keep taking their medicines.

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. Participants can stay on all their medications during this study. Information from this study may help determine how to better treat migraine.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are age 18 or older.
  • Have migraine with or without aura (changes in sight or other senses), with headaches 4–20 days a month.
  • Have had migraine for at least 1 year.
  • Can attend 8 weekly online classes and complete setup for the online platform.
  • Are willing to fill out headache logs before treatment starts.
  • Have a score above 50 on the HIT-6 survey, which measures how headaches affect daily life.
  • Are fluent in English.
  • If pregnant, are no more than 16 weeks pregnant when joining.

Who can't join

  • Have a serious or unstable physical or mental health condition that could make participation unsafe, or another condition the study doctor thinks could affect participation or needed care.
  • Have headaches caused by overusing migraine medicine.
  • Are more than 16 weeks pregnant when joining, or had a positive COVID test within 30 days before joining.
  • Started a migraine prevention treatment within 12 weeks, or a treatment for migraine attacks within 4 weeks before joining.
  • Are unwilling to keep current medicine doses steady during the study, or do not complete the starting headache logs.
  • Have heavy alcohol use and illegal drug use.
  • Are in another study that tests a treatment or could interfere with this study.
  • Have stress reduction training experience, such as daily meditation, regular use of a mindfulness app, or past mindfulness-based stress reduction training.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion 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 Exclusion Criteria: * 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 participant: COVID-positive test within 30 days of enrollment

Study sites (3)

MA

  • Cambridge Health Alliance - Center for Mindfulness and Compassion · Cambridge, MA 02141Alexandra Comeau · Study contact · acomeau@challiance.orgPaula Gardner, MD, MPH · Sub-investigatorZev Schuman-Oliver, MD · Sub-investigatorMore trials in Cambridge

NC

OH