Using Virtual Reality to Teach Mindfulness to People With Migraine (NCT07599228) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Using Virtual Reality to Teach Mindfulness to People With Migraine
United States160 participantsStarted 2026-07
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Phase one: Qualitative Interview of User Experience
Timeframe: 2 weeks
2
Phase one: rate of participants using virtual reality for migraine-- qualitative data
Timeframe: 2 weeks
3
Phase two: Efficacy as described by number of headache days