Virtual Reality (VR) for Stress Management

Not Applicable

Completed

• Conditions: Stress; Resilience; Quality of Life; Depressive Symptoms; Sleep; Anxiety; Physical Activity

• Registration Number: NCT06970652
• Lead Sponsor: City University of New York, School of Public Health

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2023-10-12
• Primary Completion: 2024-05-21
• Study Completion: 2024-05-21
• Status Verified: 2025-04
• Study First Submitted: 2025-05-06
• Study First Submitted QC: 2025-05-06
• Study First Posted: 2025-05-14
• Last Update Submitted: 2025-06-09
• Last Update Posted: 2025-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Perceived Stress	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 Outcome Measures

Name	Time	Method
Resilience	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.
Anxiety	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.
Depressive symptom	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
Quality of Life	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.
Physical activity	From enrollment to the end of treatment at 8 weeks	Measured by number of steps using Fitbit Inspire 3
Sleep	From enrollment to the end of treatment at 8 weeks	Sleep data measured by Fitbit Inspire 3
Objective stress	First collection at baseline, second collection at 2 weeks after follow-up assessment was completed	Measured by hair sample cortisol level

Trial Locations

Locations (1)

CUNY SPH; 🇺🇸 New York, New York, United States