Using Virtual Reality to Teach Mindfulness to People With Migraine
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorBrigham and Women's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Medication overuse (>10 days/month)
Vertigo/vestibular dysfunction
Active psychiatric or neurological comorbidities
Pregnancy, breastfeeding or planning pregnancy within study timeframe
Trial design
Design model
Parallel
Treatments tested in this trial
ACT therapy delivered by REACT NeuroVR headset
BehavioralThis is ACT/mindfulness therapy delivered via a virtual reality headset.
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: Treatment as usualNo intervention 0 interventions
Group B: Active TreatmentActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Phase one: Qualitative Interview of User Experience
Assessment of user experience captured using open ended questions, yes/no questions, and a 4-point scale ranging from "Very Poor" to "Very Good".
Time frame
2 weeks2
Phase one: rate of participants using virtual reality for migraine-- qualitative data
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".
Time frame
2 weeks3
Phase two: Efficacy as described by number of headache days
Time frame
6 MonthsSecondary outcomes
1
Phase two: Headache Disability Inventory
Assessment of acceptance and commitment (ACT) treatment on migraine-associated disability
Time frame
6 Months2
Phase two: Change in Inflammatory Biomarker panel-NULISAseq Inflammation 250
Will be measuring serum samples prior to study and at 12-week time to assess for change
Time frame
baseline and 12 weeks3
Anxiety and Depression
Migraine related anxiety and depression will be assessed by PROMIS29
Time frame
baseline and 12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: