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Using Virtual Reality to Teach Mindfulness to People With Migraine

Migraine Intervention Using Reality-Assisted Guided Experience

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 2 visits
  • Time periods mentioned: 4 weeks
  • Procedures mentioned: Blood draws, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether adults with migraine can learn Acceptance and Commitment Therapy (ACT), a type of mindfulness therapy, using a virtual reality (VR) headset. Researchers want to see if it helps migraines interfere less with daily life. Participants are assigned by chance to usual care or VR for four weeks, and everyone keeps symptom diaries, fills out surveys, has two clinic visits, and has blood drawn twice.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are 18–80 years old and speak English.
  • Have a diagnosis of episodic migraine, with 4–10 migraine days per month.
  • Have 4–10 headaches per month during a four-week check before treatment starts.
  • Have taken the same dose of a CGRP monoclonal antibody (mAb), a migraine prevention medicine, for at least three months.
  • Do not take other medicines to prevent migraines.
  • Are not pregnant, breastfeeding, or planning pregnancy during the study.
  • Can and will use a VR headset and follow study steps.
  • Have no history of serious mental health illness.

Who can't join

  • Overuse medicine: use it more than 10 days per month.
  • Have vertigo (a spinning feeling) or problems with the body's balance system.
  • Have a current mental health condition or another condition affecting the brain or nerves.
  • Are pregnant, breastfeeding, or planning pregnancy during the study.
  • Have major problems with sight, hearing, or movement that affect VR use.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (3)

MA