Virtual Reality Mindfulness for Migraine
(MIRAGE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The aim of this clinical trial is to learn if people with migraine can learn a type of biobehavioral therapy called Acceptance and Commitment Therapy (ACT) by using a virtual reality headset. Researchers are studying if this type of mindfulness therapy helps to decrease migraine-related disability. Participants will be randomized to treatment as usual or active virtual reality groups for four weeks. Everyone will keep symptom diaries, complete surveys, attend two clinic visits, and have two blood draws.
Who Is on the Research Team?
carolyn bernstein, MD
Principal Investigator
BWH
Are You a Good Fit for This Trial?
This trial is for adults aged 18-80 who have been diagnosed with episodic migraine (4-10 migraine days per month), are on a stable dose of certain migraine medication, not taking other preventive meds, not pregnant or breastfeeding, and able to use a VR headset. Participants must speak English and have no major psychiatric illness.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to treatment as usual or active virtual reality groups for four weeks. Active participants use a VR device at home and engage in various experiences.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including changes in inflammatory biomarkers and migraine-related anxiety and depression.
What Are the Treatments Tested in This Trial?
Interventions
- ACT therapy delivered by REACT NeuroVR headset
Trial Overview
The study tests if mindfulness therapy called Acceptance and Commitment Therapy (ACT) can be taught using a virtual reality headset to help people with migraines. Participants are randomly assigned to either usual care or the VR-ACT group for four weeks.
How Is the Trial Designed?
2
Treatment groups
Active Control
This group will remain on their CGRP injectable monoclonal antibody migraine preventive medication
This group will participate in the four week active virtual reality treatment and will also remain on their CGRP mAb medication.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Brigham and Women's Hospital
Lead Sponsor
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