Clinical trial NCT06970652: Virtual Reality (VR) for Stress Management
Official title: Virtual Reality Intervention for Stress Reduction Among Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Resilience
Quality of Life
Depressive Symptoms
Anxiety
Sleep
Physical Activity
Keywords: virtual reality
young adults
stress
stress management
Lead sponsor: City University of New York, School of Public Health
Sponsor class: OTHER
Collaborators: name: MindCo Health
First posted: 2025-05-14
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Perceived Stress
timeFrame: From enrollment to the end of treatment at 8 weeks
Secondary outcomes:
measure: Resilience
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Anxiety
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Depressive symptom
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Quality of Life
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Physical activity
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Sleep
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Objective stress
timeFrame: First collection at baseline, second collection at 2 weeks after follow-up assessment was completed
Other outcomes:
Locations:
city: New York
country: United States
facility: CUNY SPH
state: New York
Study officials:
References: