Clinical trial NCT05987592: BE WELL With Migraine: Brain Education and WELLness With Migraine
Official title: BE WELL With Migraine: Brain Education and WELLness With Migraine
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Migraine
Keywords: Migraine
Migraine without aura
Migraine with aura
behavioral
mind-body
integrative
virtual
online
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2023-08-14
Enrollment: 286
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm parallel assignment in which one group receives treatment A and the other group receives treatment B
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: This study involves 8 weekly virtual sessions \& an online platform designed to improve the lives of patients with migraine. Participants from across the United States with migraine may be eligible to participate. This study does not require any in-person visits. All assessments and surveys will be completed virtually and/or online. Participants will independently complete an initial online screen. Participants will attend a scheduled phone or videoconferencing call with a study team member to complete the baseline assessment and learn how to use the online platform. Participants will keep an online daily headache log and complete several online surveys throughout the study.

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

Primary outcomes:
measure: Disability assessed using monthly Migraine Disability Assessment (mMIDAS) - Change in Migraine Disability from baseline to 8 weeks
timeFrame: Immediately post-intervention at 8 weeks
Secondary outcomes:
measure: Depression assessed using Patient Health Questionnaire (PHQ-8) Questionnaire - Change in Depression from baseline to 8 weeks
timeFrame: Immediately post-intervention at 8 weeks
measure: Pain Catastrophizing quantified using Pain Catastrophizing Scale (PCS) - Change in Pain catastrophizing from baseline to 8 weeks
timeFrame: Immediately post-intervention at 8 weeks
measure: Self-Efficacy assessed with the Headache Management Self-Efficacy Scale (HMSE) - Change in Self-efficacy from baseline to 8 weeks
timeFrame: Immediately post-intervention at 8 weeks
measure: Disability assessed using monthly Migraine Disability Assessment (mMIDAS) at 20 weeks - Change in migraine disability from baseline to 20 weeks
timeFrame: Post-intervention at 20 weeks
measure: Disability assessed using monthly Migraine Disability Assessment (mMIDAS) at 32 weeks - Change in migraine disability from baseline to 32 weeks
timeFrame: Post-intervention at 32 weeks
measure: Anxiety assessed using Generalized Anxiety Disorder-7 (GAD-7) at 8 weeks - Change in anxiety from baseline to 8 weeks
timeFrame: Immediately post-intervention at 8 weeks
measure: Quality of Life assessed using Migraine Specific Quality of Life version 2.1 (MSQL v2.1) at 8 weeks
timeFrame: Immediately post-intervention at 8 weeks
measure: Migraine frequency using the daily and 7-day recall headache log at 8 weeks - Change in migraine frequency from baseline to 8 weeks
timeFrame: Immediately post-intervention at 8 weeks
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Cambridge Health Alliance - Center for Mindfulness and Compassion
state: Massachusetts
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Wake Forest University Health Sciences
name: Rebecca E Wells, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: