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OpenTrials
Completed

NCT Number: NCT06970652

Virtual Reality (VR) for Stress Management

This is a randomized pilot trial that aims to examine the impact of smartphone-based Virtual Reality (VR) intervention, MindCo Relief, in reducing stress levels and perceived anxiety, depression, and quality of life among young adults.

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Key information

Age range

18 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CUNY SPH

New York, 10025, United States

About this study

Research has shown that young adults are more likely to experience high stress levels due to the combined pressures of academic achievement, career development, financial strain, and navigating interpersonal relationships. High stress levels may contribute to sleep disturbances, anxiety, and depressive symptoms. While cognitive-behavioral therapy (CBT) and mindfulness-based stress reduction (MBSR) have shown effectiveness, traditional interventions are not always accessible or appealing to young adults due to barriers such as stigma, availability, or personal preference.

This study aims to assess the feasibility and preliminary efficacy of MindCo Relief, a mobile virtual reality (VR)-based stress management program. The study will recruit 70 young adults aged 18-29 residing in New York City who report moderate to high perceived stress based on the Perceived Stress Scale (PSS-10). Participants must own a smartphone (iOS or Android), be able to operate the study app, and not be enrolled in other stress reduction programs or have photosensitive epilepsy. After online eligibility screening and signed the informed consent, participants will visit the City University of New York Graduate School of Public Health and Health Policy (CUNY SPH) for baseline assessments, hair sample collection, and equipment setup. Participants will be randomized to either the intervention or a control group (no active treatment). All participants will be asked to wear a Fitbit Inspire 3 throughout the 8-week study to track physical activity and sleep.

The intervention group will receive access to the MindCo Relief mobile application and a VR headset. The program combining immersive VR mindfulness exercises, cognitive-behavioral education, and self-reflective journaling. Participants may also access up to three optional coaching sessions delivered by trained behavioral health professionals. The control group will complete the same assessments on the same schedule but will not receive any intervention during the study.

Primary and secondary outcomes will be assessed at baseline and 8 weeks post-intervention. The primary outcome is perceived stress (PSS-10). Secondary outcomes include resilience (CD-RISC2), anxiety (GAD-7), depression (PHQ-9), quality of life (GWS), and sleep quality. Hair cortisol will be used to evaluate biological stress response. All survey-based outcomes will be collected online using REDCap.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Young adults ages 18-29
  • Self-reporting moderate or high perceived stress (PSS-10 score 14 or above)
  • able to participate in the trial within 2 weeks after signing informed consent
  • have access to a smartphone
  • accept to have a hair fragments table for hair cortisol level measurements

Exclusion criteria

  • Participating in other stress reduction programs
  • With photosensitive epilepsy for safety reasons.

Treatment and study plan

Virtual reality

Device

Participants in the intervention group received access to the MR smartphone application and a smartphone-compatible VR headset, both developed by MindCo Health.32 The application contained a stress reduction program that comprised a structured sequence of 77 modules designed to be completed over the course of 8 weeks. Each module was designed to be completed in approximately 7 minutes, and each module needed to be completed before progressing to the next module. Forty modules used VR, and for these modules, participants placed their personal smartphones running the MR application in the VR headset, and the smartphone provided all audiovisual content. All other modules used smartphones without the VR headset.

Primary outcomes

  1. Perceived Stress

    Time frame: From enrollment to the end of treatment at 8 weeks

    Measured by the perceived stress scale 10 Scoring ranges from 0 - 40, and a higher score represents a higher perceived stress. Cutoffs are 0-13 low stress, 14-26 moderate stress, 27-40 high stress

Secondary outcomes

  1. Resilience

    Time frame: From enrollment to the end of treatment at 8 weeks

    Measured by Connor-Davidson Resilience Scale 2 items Scoring ranges from 0 - 8, a higher score represents higher resilience.

  2. Anxiety

    Time frame: From enrollment to the end of treatment at 8 weeks

    General Anxiety Disorder 7 Scoring ranges from 0 - 21, and a higher score represents more severe anxiety. Cutoffs are 0-4 minimal anxiety, 5-9 mild anxiety, 10-14 moderate anxiety, 15-21 severe anxiety.

  3. Depressive symptom

    Time frame: From enrollment to the end of treatment at 8 weeks

    Patient Health Questionnaire - 9

    The scoring ranges from 0 -27, a higher score represents a more severe depressive symptom. Cutoffs are listed below:

    0-4 none-minimal 5-9 mild 10-14 moderate 15-19 moderately severe 20-27 severe

  4. Quality of Life

    Time frame: From enrollment to the end of treatment at 8 weeks

    Measured by general well-being schedule The total score ranges from 0 - 110, with a lower score indicating more severe distress. Cutoffs are 0-60 severe distress, 61-72 moderate distress, 73-110 positive well-being.

  5. Physical activity

    Time frame: From enrollment to the end of treatment at 8 weeks

    Measured by number of steps using Fitbit Inspire 3

  6. Sleep

    Time frame: From enrollment to the end of treatment at 8 weeks

    Sleep data measured by Fitbit Inspire 3

  7. Objective stress

    Time frame: First collection at baseline, second collection at 2 weeks after follow-up assessment was completed

    Measured by hair sample cortisol level

Sponsors and collaborators

Lead sponsor

City University of New York, School of Public Health

Other

Collaborators

  • MindCo Health

Registry information

Official study title

Virtual Reality Intervention for Stress Reduction Among Young Adults

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 14, 2025
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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