An interventional study of ACT therapy delivered by REACT NeuroVR headset in Migraine Disorders, Migraine With Aura and Migraine Without Aura, sponsored by Brigham and Women's Hospital. Not yet recruiting at 3 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Treatment
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.
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
Exclusion Criteria:
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.
Behavioral: ACT therapy delivered by REACT NeuroVR headset
This is ACT/mindfulness therapy delivered via a virtual reality headset.
Phase one: Qualitative Interview of User Experience
Assessment of user experience captured using open ended questions, yes/no questions, and a 4-point scale ranging from "Very Poor" to "Very Good".
Time frame: 2 weeks
Phase one: rate of participants using virtual reality for migraine-- qualitative data
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".
Time frame: 2 weeks
Phase two: Efficacy as described by number of headache days
Time frame: 6 Months
Phase two: Headache Disability Inventory
Assessment of acceptance and commitment (ACT) treatment on migraine-associated disability
Time frame: 6 Months
Phase two: Change in Inflammatory Biomarker panel-NULISAseq Inflammation 250
Will be measuring serum samples prior to study and at 12-week time to assess for change
Time frame: baseline and 12 weeks
Anxiety and Depression
Migraine related anxiety and depression will be assessed by PROMIS29
Time frame: baseline and 12 weeks
Plan to share: Yes — We will share demographics including age and sex within the BWH researchers.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Brigham and Women's Hospital