Using Virtual Reality to Teach Mindfulness to People With Migraine (MIRAGE)

May 14, 2026 updated by: Carolyn A. Bernstein, Brigham and Women's Hospital

Migraine Intervention Using Reality-Assisted Guided Experience

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is designed to evaluate the clinical utility of REACT NeuroVR in patients with episodic migraine who are already receiving stable CGRP monoclonal antibody therapy. By combining pharmacologic advances with digitally delivered psychological support, we aim to assess whether this integrated approach can further reduce headache frequency, improve migraine-specific quality of life, and reduce anticipatory anxiety. Additionally, we will explore changes in inflammatory biomarkers to examine potential physiologic correlates of intervention-related improvement.

Ultimately, this study addresses a critical gap in migraine care: the integration of effective, accessible behavioral health strategies into the treatment paradigm for patients who continue to experience burdensome symptoms despite preventive therapy.

1. Specific Aims and Objectives

Aim 1 (Pilot and Feasibility Study):

To evaluate the feasibility, acceptability, and usability of personalized Acceptance and Commitment Therapy (ACT) delivered via REACT NeuroVR. Focus groups with key stakeholders (patients, clinicians, and implementation experts) will be conducted to obtain feedback on intervention content, delivery, and outcome measures. Insights from this pilot phase will inform refinements to the intervention and study procedures for the subsequent full-scale clinical trial.

Aim 2 (Primary Efficacy Aim):

To determine whether personalized ACT therapy delivered via REACT NeuroVR reduces the number of monthly headache days in patients with episodic migraine compared to baseline.

Aim 3 (Psychological and Functional Outcomes):

To evaluate whether REACT NeuroVR improves migraine-specific quality of life and reduces anticipatory anxiety related to migraine events.

Aim 4 (Exploratory Biological and Sensory Aims):

To explore changes in inflammatory biomarkers.

Participants will:

Be randomized to treatment as usual or active VR participants Everyone who completes run-in will have a chance to try the VR device and have an additional screen.

Everyone will have a blood test at the beginning and the end of the study. Active participants will be loaned a VR device to take home for four weeks and will do the study activities as well as use a variety of experiences when they choose (such as beach visits, virtual ice baths and others) Participants will fill out surveys throughout the study.

Visit the clinic twice during the study Keep a diary of their symptoms and number of migraines

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02155
        • Brigham and Womens Hospital
      • Chestnut Hill, Massachusetts, United States, 02467
        • Brigham and Women's Hospital
      • Chestnut Hill, Massachusetts, United States, 02467
        • Brigham and Women's Health Care Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults aged 18-80
  • Diagnosed with episodic migraine and experience 4-10 migraine days/month
  • On a stable dose of CGRP mAb for three months prior
  • Satisfy 4 week run-in of 4-10 headaches/month
  • Not taking other preventive medications
  • Not pregnant, breastfeeding, or planning to become pregnant within study timeframe
  • Able and willing to use VR device
  • No history of significant psychiatric illness
  • Willing to comply with study procedures
  • English-speaking

Exclusion Criteria:

  • Medication overuse (>10 days/month)
  • Vertigo/vestibular dysfunction
  • Active psychiatric or neurological comorbidities
  • Pregnancy, breastfeeding or planning pregnancy within study timeframe
  • Significant visual/hearing/mobility impairment affecting VR use

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Treatment as usual
This group will remain on their CGRP injectable monoclonal antibody migraine preventive medication
Active Comparator: Active Treatment
This group will participate in the four week active virtual reality treatment and will also remain on their CGRP mAb medication.
Behavioral: ACT therapy delivered by REACT NeuroVR headset
This is ACT/mindfulness therapy delivered via a virtual reality headset.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase one: Qualitative Interview of User Experience
Time Frame: 2 weeks
Assessment of user experience captured using open ended questions, yes/no questions, and a 4-point scale ranging from "Very Poor" to "Very Good".
2 weeks
Phase one: rate of participants using virtual reality for migraine-- qualitative data
Time Frame: 2 weeks
Assessment of how often and how long participants used the devices. Two 6-point scales included ranging from "Never" to "12-14 days" as well as "Under 10 minutes" to "More than 2 hours".
2 weeks
Phase two: Efficacy as described by number of headache days
Time Frame: 6 Months
6 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase two: Headache Disability Inventory
Time Frame: 6 Months
Assessment of acceptance and commitment (ACT) treatment on migraine-associated disability
6 Months
Phase two: Change in Inflammatory Biomarker panel-NULISAseq Inflammation 250
Time Frame: baseline and 12 weeks
Will be measuring serum samples prior to study and at 12-week time to assess for change
baseline and 12 weeks
Anxiety and Depression
Time Frame: baseline and 12 weeks
Migraine related anxiety and depression will be assessed by PROMIS29
baseline and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Investigators

  • Principal Investigator: carolyn bernstein, MD, BWH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

August 1, 2029

Study Completion (Estimated)

January 1, 2031

Study Registration Dates

First Submitted

April 28, 2026

First Submitted That Met QC Criteria

May 14, 2026

First Posted (Actual)

May 20, 2026

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 14, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026P000879

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We will share demographics including age and sex within the BWH researchers.

IPD Sharing Time Frame

current to completion of final publication, approximately five years

IPD Sharing Access Criteria

Only BWH research team will have access to the IPD

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Migraine Disorders

Clinical Trials on ACT therapy delivered by REACT NeuroVR headset

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in New Zealand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe