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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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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
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

Other trials in United States

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:

  1. PROMIS - Short Form Anxiety (8 questions)
  2. PROMIS - Short Form Depression (8 questions)
  3. Perceived Stress Scale (10 questions)
  4. Connor-Davidson Brief Resilience Scale (10 questions)
  5. 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.

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 groups in NCT06246539
Study groupRoleWhat they receive
Intervention - VR MindfulnessExperimentalThe 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
ControlNo interventionThe 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.

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  1. First posted7 Feb 2024
  2. Study start1 Oct 2026
  3. Primary completion1 Jan 2028 (estimated)
  4. Study completion31 Jul 2028 (estimated)

Resources

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)
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

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.

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