- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06246539
Impact of a Virtual Reality-based Mindfulness Program on Clinician Wellness
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Cohorts 1 will be the intervention group Cohorts 2 will be the controls. Study endpoints include results from the following questionnaires:
- PROMIS - Short Form Anxiety (8 questions)
- PROMIS - Short Form Depression (8 questions)
- Perceived Stress Scale (10 questions)
- Connor-Davidson Brief Resilience Scale (10 questions)
- System Usability Scale (10 questions)
The intervention is a 12-week mindfulness-based VR intervention.
Cohort 1 will complete the questionnaires 1-4 at baseline (just before the intervention). They will be sent twice weekly reminders to use the VR for the duration of the 12-week intervention. After 12 weeks Cohort 1 will retake questionnaires 1-4 and take questionnaire 5, while Cohort 2 will then take questionnaires 1-4 and be provided the VR headsets. After another 12 weeks, Cohort 1 will take questionnaires 1-4 and be done with the study, while Cohort 2 will take questionnaires 1-5. After 12 more weeks, Cohort 2 will take questionnaires 1-4 and be done with the study.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Steven Bird, MD
- Phone Number: 508-421-1422
- Email: steven.bird@umassmemorial.org
Study Locations
-
-
Massachusetts
-
Worcester, Massachusetts, United States, 01655-0002
- UMassMemorial Health Care
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- physician or APP employed by the Medical Group
Exclusion Criteria:
- Not willing to receive 2 texts per week
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
The control arm will not have any intervention.
However, at the conclusion of the study, all participants from the Control group will be given the VR intervention
|
|
|
Experimental: Intervention - VR Mindfulness
The intervention group will be given the VR headset for their unrestricted use over the 12 week intervention period.
The VR headset is exceptionally easy and intuitive to use.
Each participant will have the choice of 20 "locations" in which to use the mindfulness-based program.
Each of the 20 locations/programs are different.
They range in length from 5 minutes (introductory) to 20 minutes.
|
VR-based mindfulness
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PROMIS - anxiety
Time Frame: at baseline, after 12 weeks, then after another 12 weeks. We will compare results of the intervention group at 12 and 24 weeks to their baseline.
|
PROMIS Short Form - anxiety scale.
Scores of 8-40; Higher is a worse outcome.
|
at baseline, after 12 weeks, then after another 12 weeks. We will compare results of the intervention group at 12 and 24 weeks to their baseline.
|
|
PROMIS - anxiety
Time Frame: at baseline, after 12 weeks, then after another 12 weeks. We will compare results of the control group at 12 and 24 weeks to their baseline.
|
PROMIS Short Form - anxiety scale.
Scores of 8-40; Higher is a worse outcome.
|
at baseline, after 12 weeks, then after another 12 weeks. We will compare results of the control group at 12 and 24 weeks to their baseline.
|
|
PROMIS - Depression
Time Frame: at baseline, after 12 weeks, then after another 12 weeks. We will compare results of the intervention group at 12 and 24 weeks to their baseline.
|
PROMIS Short Form - Depression scale.
Scores of 8-40; Higher is a worse outcome.
|
at baseline, after 12 weeks, then after another 12 weeks. We will compare results of the intervention group at 12 and 24 weeks to their baseline.
|
|
PROMIS - Depression
Time Frame: at baseline, after 12 weeks, then after another 12 weeks. We will compare results of the control group at 12 and 24 weeks to their baseline.
|
PROMIS Short Form - Depression scale.
Scores of 8-40; Higher is a worse outcome.
|
at baseline, after 12 weeks, then after another 12 weeks. We will compare results of the control group at 12 and 24 weeks to their baseline.
|
|
Resiliency
Time Frame: at baseline, after 12 weeks, then after another 12 weeks. We will compare results of the intervention group at 12 and 24 weeks to their baseline.
|
Connor-Davidson Resiliency Scale.
Scores of 0-40; Higher score is better.
|
at baseline, after 12 weeks, then after another 12 weeks. We will compare results of the intervention group at 12 and 24 weeks to their baseline.
|
|
Resiliency
Time Frame: at baseline, after 12 weeks, then after another 12 weeks. We will compare results of the control group at 12 and 24 weeks to their baseline.
|
Connor-Davidson Resiliency Scale.
Scores of 0-40; Higher score is better.
|
at baseline, after 12 weeks, then after another 12 weeks. We will compare results of the control group at 12 and 24 weeks to their baseline.
|
|
Stress scale
Time Frame: at baseline, after 12 weeks, then after another 12 weeks. We will compare results of the control group at 12 and 24 weeks to their baseline.
|
Perceived Stress Score.
Scores of 0-40; Higher score is worse.
|
at baseline, after 12 weeks, then after another 12 weeks. We will compare results of the control group at 12 and 24 weeks to their baseline.
|
|
Usability
Time Frame: after 12 weeks we will dertermine the usability of the VR intervention in the intervention group
|
Usability scale.
Scores of 10-50; Higher score is better.
|
after 12 weeks we will dertermine the usability of the VR intervention in the intervention group
|
|
Stress scale
Time Frame: at baseline, after 12 weeks, then after another 12 weeks. We will compare results of the intervention group at 12 and 24 weeks to their baseline.
|
Perceived Stress Score.
Scores of 0-40; Higher score is worse.
|
at baseline, after 12 weeks, then after another 12 weeks. We will compare results of the intervention group at 12 and 24 weeks to their baseline.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Steven Bird, MD, University of Massachusetts, Worcester
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00001606
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Wellness, Psychological
-
Cedars-Sinai Medical CenterNot yet recruitingMental Health Wellness 1 | Wellness, PsychologicalUnited States
-
Methodist Health SystemCompletedWellness, PsychologicalUnited States
-
Universitat Autonoma de BarcelonaNous Cims Private FoundationActive, not recruitingMental Health Wellness | Psychological Well-BeingSpain
-
CorStoneDavid and Lucile Packard FoundationActive, not recruitingMental Health Wellness 1 | Resilience, PsychologicalIndia
-
The University of Hong KongActive, not recruitingPsychological Distress | Mental Health Wellness 1Hong Kong
-
Stanford UniversityActive, not recruitingResilience, Psychological | Wearable Devices | Psychological Wellness | Personal and Professional Fulfilment | MultiomicsUnited States
-
University of BucharestRecruitingMental Health Wellness 1 | Well-Being, PsychologicalRomania
-
University of WashingtonNational Center for Advancing Translational Sciences (NCATS)CompletedParenting | Mental Health Wellness 1 | Well-Being, PsychologicalUnited States
-
University of WestminsterGencor Pacific GroupCompletedWellness, Psychological | Well-Being, PsychologicalUnited Kingdom
-
AdventHealthCompletedPsychological WellnessUnited States
Clinical Trials on VR mindfulness
-
Alexandra HospitalNot yet recruitingKidney Failure, Chronic
-
The University of Hong KongNew Life Psychiatric Rehabilitation AssociationNot yet recruitingMental WellbeingHong Kong
-
Javier Garcia CampayoCompletedMental Health Wellness 1Spain
-
Penn State UniversityNot yet recruitingDepression | Stress | AnxietyUnited States
-
Taipei Medical UniversityNational Science and Technology CouncilCompletedQuality of Life | Caregivers of People With DementiaTaiwan
-
Babes-Bolyai UniversityCluj-Napoca County Emergency Clinical Hospital, Surgery Department 2Not yet recruitingPain, Postoperative | Anxiety Preoperative
-
Inland Norway University of Applied SciencesThe Research Council of NorwayCompletedChronic Pain | RehabilitationNorway
-
Weill Medical College of Cornell UniversityBrain & Behavior Research FoundationCompletedAnxiety | Distress, EmotionalUnited States
-
Nanjing University of Traditional Chinese MedicineCompletedStress | COVID-19 Pandemic | Nurse's RoleChina
-
The University of Hong KongFood and Health Bureau, Hong Kong; Lingnan UniversityNot yet recruitingDementia | Caregiver Burden of People With Dementia