Episodic Migraine, Migraine Disorders, Migraine With Aura, Migraine Without Aura
Conditions
Keywords
acceptance and commitment therapy (ACT), migraine, virtual reality, mindfulness, Calcitonin Gene-Related Peptide monoclonal antibody therapy
Brief 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.
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
BEHAVIORALACT therapy delivered by REACT NeuroVR headset
This is ACT/mindfulness therapy delivered via a virtual reality headset.
Sponsors
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
There will be two groups, treatment as usual and active intervention.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase one: Qualitative Interview of User Experience | 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 | 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 | 6 Months | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase two: Headache Disability Inventory | 6 Months | Assessment of acceptance and commitment (ACT) treatment on migraine-associated disability |
| Phase two: Change in Inflammatory Biomarker panel-NULISAseq Inflammation 250 | baseline and 12 weeks | Will be measuring serum samples prior to study and at 12-week time to assess for change |
| Anxiety and Depression | baseline and 12 weeks | Migraine related anxiety and depression will be assessed by PROMIS29 |
Countries
United States
Contacts
CONTACTcarolyn bernstein, MD
CONTACTasimina lazaridou, PhD
PRINCIPAL_INVESTIGATORcarolyn bernstein, MD
BWH
Outcome results
None listed