Wellness, PsychologicalNCT06246539
Impact of a Virtual Reality-based Mindfulness Program on Clinician Wellness
A study testing VR mindfulness in people with Wellness, Psychological, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
Burnout shares symptoms with anxiety and depression. While there is no single intervention for burnout, there are validated interventions (which are amenable to virtual reality (VR)) for anxiety and depression. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Wellness, Psychological
- What is being tested?
- VR mindfulness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- physician or APP employed by the Medical Group
Who cannot join
- Not willing to receive 2 texts per week
Trial locations and contacts
1 site in 1 country.
United States1 site
UMassMemorial Health Care
Worcester, Massachusetts, 01655-0002
About this study
Burnout shares symptoms with anxiety and depression. While there is no single intervention for burnout, there are validated interventions (which are amenable to virtual reality (VR)) for anxiety and depression. UMassMemorial data from the Professional Well-Being Academic Consortium show that MD burnout and distress has increased since 2020. The investigators believe providing clinicians with a unique tool (VR) will be a feasible and efficacious way to tackle distress. It is known that only 1% of our MDs have done mindfulness training but nearly 50% are interested in doing so. Therefore, a self-administrable, interactive mindfulness program delivered over VR has great potential to reach clinicians who want to practice a more active form of mindfulness at a time convenient to them. The results of the study will provide preliminary evidence to determine if a take-home VR mindfulness program decreases clinician stress.
Read the 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.
- Conditions
- Wellness, Psychological
- Being tested
- VR mindfulness
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR mindfulnessBehavioural
VR-based mindfulness
| Study group | Role | What they receive |
|---|---|---|
| Intervention - VR Mindfulness | Experimental | 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. Receives: Behavioral: VR mindfulness |
| Control | No intervention | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PROMIS - anxiety
PROMIS Short Form - anxiety scale. Scores of 8-40; Higher is a worse outcome.
Measured: 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
PROMIS Short Form - anxiety scale. Scores of 8-40; Higher is a worse outcome.
Measured: 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
PROMIS Short Form - Depression scale. Scores of 8-40; Higher is a worse outcome.
Measured: 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
PROMIS Short Form - Depression scale. Scores of 8-40; Higher is a worse outcome.
Measured: 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
Connor-Davidson Resiliency Scale. Scores of 0-40; Higher score is better.
Measured: 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
Connor-Davidson Resiliency Scale. Scores of 0-40; Higher score is better.
Measured: 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
Perceived Stress Score. Scores of 0-40; Higher score is worse.
Measured: 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.
Stress scale
Perceived Stress Score. Scores of 0-40; Higher score is worse.
Measured: 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
Usability scale. Scores of 10-50; Higher score is better.
Measured: after 12 weeks we will dertermine the usability of the VR intervention in the intervention group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start1 Oct 2026
- Primary completion1 Jan 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wellness, PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven Bird, University of Massachusetts, Worcester
- Investigators
- Steven Bird, MD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06246539
- Sponsor's protocol ID
- 00001606
- Status last verified
- Oct 2026
- First submitted
- 30 Jan 2024
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Virtual Reality-based Mindfulness Program on Clinician Wellness
- ClinicalTrials.gov ID
- NCT06246539
- Acronym / sponsor ID
- 00001606
- Conditions
- Wellness, Psychological
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Study start
- 1 Oct 2026 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 7 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Burnout shares symptoms with anxiety and depression. While there is no single intervention for burnout, there are validated interventions (which are amenable to virtual reality (VR)) for anxiety and depression. UMassMemorial data from the Professional Well-Being Academic Consortium show that MD burnout and distress has increased since 2020. The investigators believe providing clinicians with a unique tool (VR) will be a feasible and efficacious way to tackle distress. It is known that only 1% of our MDs have done mindfulness training but nearly 50% are interested in doing so. Therefore, a self-administrable, interactive mindfulness program delivered over VR has great potential to reach clinicians who want to practice a more active form of mindfulness at a time convenient to them. The results of the study will provide preliminary evidence to determine if a take-home VR mindfulness program decreases clinician stress.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention - VR Mindfulness | Experimental | Behavioral: VR mindfulnessThe 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. |
| Control | No intervention | –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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- physician or APP employed by the Medical Group
Key exclusion criteria (1 listed)
- Not willing to receive 2 texts per week
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR mindfulnessVR-based mindfulness | Behavioural | Intervention - VR Mindfulness |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Bird, MD principal investigator
University of Massachusetts, Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR mindfulness in people with Wellness, Psychological, run by University of Massachusetts, Worcester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.