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

Mass General Brigham

Status: Not yet enrolling

Conditions: Migraine With Aura; Migraine Disorders; Migraine Without Aura; Episodic Migraine

Treatments: Behavioral: ACT therapy delivered by REACT NeuroVR headset

Study type: Interventional

Funder types: Other

Identifiers

NCT07599228

2026P000879

Details and patient eligibility

About

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.

Full 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

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 2 patient groups

Treatment as usual

No Intervention group

Description:

This group will remain on their CGRP injectable monoclonal antibody migraine preventive medication

Active Treatment

Active Comparator group

Description:

This group will participate in the four week active virtual reality treatment and will also remain on their CGRP mAb medication.

Treatment:

Behavioral: ACT therapy delivered by REACT NeuroVR headset