BEHAVIORAL
ACT therapy delivered by REACT NeuroVR headset
This is ACT/mindfulness therapy delivered via a virtual reality headset.
Status
Not yet recruiting
Phase
Not applicable
Enrollment
160
Locations
3
Results
Not posted
Publications
7
Study summary
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
Interventions
BEHAVIORAL
This is ACT/mindfulness therapy delivered via a virtual reality headset.
Timeline
First posted
May 20, 2026
Study start
Jul 2026
Primary completion
Aug 2029
Study completion
Jan 2031
Results posted
Not reported
Registry updated
May 20, 2026
Outcomes
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".
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".
Phase two: Efficacy as described by number of headache days
Time frame · 6 Months
Phase two: Headache Disability Inventory
Time frame · 6 Months
Assessment of acceptance and commitment (ACT) treatment on migraine-associated disability
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
Anxiety and Depression
Time frame · baseline and 12 weeks
Migraine related anxiety and depression will be assessed by PROMIS29
Eligibility
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 locations
United States. Showing up to 24 locations stored in the fast local snapshot.
Brigham and Womens Hospital
Boston, Massachusetts, United States
Brigham and Women's Health Care Center
Chestnut Hill, Massachusetts, United States
Brigham and Women's Hospital
Chestnut Hill, Massachusetts, United States
Publications
Related trials
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa · Migraine · Headache
Not applicable
Completed
513
2026-07
Jordan University of Science and Technology · Root Canal Treatment · Postoperative Pain
Not applicable
Active, not recruiting
75
2026-07
Tanta University · Calcitonin · Subcutaneous
Phase 3
Recruiting
168
2026-07
Insel Gruppe AG, University Hospital Bern · Acute Mountain Sickness
Phase 4
Not yet recruiting
30
2026-07
Institut Claudius Regaud · Medullary Thyroid Cancer
Not applicable
Completed
24
2026-06
Rigmor Højland Jensen · Idiopathic Intracranial Hypertension (IIH)
Phase 3
Not yet recruiting
96
2026-06
IRCCS San Raffaele Roma · Episodic Migraine · Chronic Migraine
Not applicable
Recruiting
2,641
2026-06
Pamukkale University · Neck Pain · Text Neck Syndrome
Not applicable
Completed
38
2026-05
Related PeptideStat pages
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.