Current partner codePEPTIDESDE
NCT07599228·Not applicable·INTERVENTIONAL

Using Virtual Reality to Teach Mindfulness to People With Migraine

Status

Not yet recruiting

Phase

Not applicable

Enrollment

160

Locations

3

Results

Not posted

Publications

7

Study summary

What the protocol is testing.

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 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

Interventions

Treatment arms and agents.

BEHAVIORAL

ACT therapy delivered by REACT NeuroVR headset

This is ACT/mindfulness therapy delivered via a virtual reality headset.

Timeline

From registration to results.

  1. First posted

    May 20, 2026

  2. Study start

    Jul 2026

  3. Primary completion

    Aug 2029

  4. Study completion

    Jan 2031

  5. Results posted

    Not reported

  6. Registry updated

    May 20, 2026

Outcomes

What the study measures.

Primary 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

Secondary outcomes

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

Who can take part.

Minimum age
18 Years
Maximum age
80 Years
Sex
ALL
Healthy volunteers
No

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

3 registered sites.

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

Results and literature.

PMID 37176049Yamanaka G, Hayashi K, Morishita N, Takeshita M, Ishii C, Suzuki S, Ishimine R, Kasuga A, Nakazawa H, Takamatsu T, Watanabe Y, Morichi S, Ishida Y, Yamazaki T, Go S. Experimental and Clinical Investigation of Cytokines in Migraine: A Narrative Review. Int J Mol Sci. 2023 May 6;24(9):8343. doi: 10.3390/ijms24098343.PMID 37521355Viderman D, Tapinova K, Dossov M, Seitenov S, Abdildin YG. Virtual reality for pain management: an umbrella review. Front Med (Lausanne). 2023 Jul 14;10:1203670. doi: 10.3389/fmed.2023.1203670. eCollection 2023.PMID 35962530Thuraiaiyah J, Erritzoe-Jervild M, Al-Khazali HM, Schytz HW, Younis S. The role of cytokines in migraine: A systematic review. Cephalalgia. 2022 Dec;42(14):1565-1588. doi: 10.1177/03331024221118924. Epub 2022 Aug 12.PMID 32982095R P, S C N, S H, K R. Migraine Disability, Quality of Life, and Its Predictors. Ann Neurosci. 2020 Jan;27(1):18-23. doi: 10.1177/0972753120929563. Epub 2020 Jul 3.PMID 39974259P AS, S G. Acceptance and Commitment Therapy and Psychological Well-Being: A Narrative Review. Cureus. 2025 Jan 20;17(1):e77705. doi: 10.7759/cureus.77705. eCollection 2025 Jan.PMID 37016284Musubire AK, Cheema S, Ray JC, Hutton EJ, Matharu M. Cytokines in primary headache disorders: a systematic review and meta-analysis. J Headache Pain. 2023 Apr 4;24(1):36. doi: 10.1186/s10194-023-01572-7.PMID 36909005Aditya S, Rattan A. Advances in CGRP Monoclonal Antibodies as Migraine Therapy: A Narrative Review. Saudi J Med Med Sci. 2023 Jan-Mar;11(1):11-18. doi: 10.4103/sjmms.sjmms_95_22. Epub 2023 Jan 14.

Primary links

Continue at the source.

Related trials

More studies on Calcitonin.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.