StressNCT06970652
Virtual Reality (VR) for Stress Management
A study testing virtual reality in people with Stress and Resilience, run by City University of New York, School of Public Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Resilience, Quality of Life
- What is being tested?
- virtual reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2023to 21 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Participating in other stress reduction programs
- With photosensitive epilepsy for safety reasons.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Virtual Reality Intervention for Stress Reduction Among Young Adults
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.
Read the 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.
- Conditions
- Stress, Resilience, Quality of Life, Depressive Symptoms, Anxiety, Sleep
- Being tested
- virtual reality
- Keywords
- virtual reality, young adults, stress, stress management
- Medical subject headings
- Depression, Anxiety Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual realityDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Intervention | Experimental | MindCo Relief, a mobile VR-based stress management application Receives: Device: virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress
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
Measured: From enrollment to the end of treatment at 8 weeks
Secondary outcomes (7)
Resilience
Measured by Connor-Davidson Resilience Scale 2 items Scoring ranges from 0 - 8, a higher score represents higher resilience.
Measured: From enrollment to the end of treatment at 8 weeks
Anxiety
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.
Measured: From enrollment to the end of treatment at 8 weeks
Depressive symptom
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
Measured: From enrollment to the end of treatment at 8 weeks
Quality of Life
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.
Measured: From enrollment to the end of treatment at 8 weeks
Physical activity
Measured by number of steps using Fitbit Inspire 3
Measured: From enrollment to the end of treatment at 8 weeks
Sleep
Sleep data measured by Fitbit Inspire 3
Measured: From enrollment to the end of treatment at 8 weeks
Objective stress
Measured by hair sample cortisol level
Measured: First collection at baseline, second collection at 2 weeks after follow-up assessment was completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start12 Oct 2023
- Primary completion21 May 2024
- Study completion21 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StressStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- City University of New York, School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- MindCo Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06970652
- Sponsor's protocol ID
- 2023-0338-PHHP
- Status last verified
- Apr 2025
- First submitted
- 6 May 2025
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be available upon reasonable request.
Publications
Hong H, Lootens MR, Bachman R, Olivera Leon LD, Dunlap AF, Goldenhersch E, Rosencovich N, Waitman C, Wyka KE, Huang TT. A Mobile Virtual Reality-Based Intervention for Stress Reduction Among Young Adults: Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2026 Aug 21;14:e83438. doi: 10.2196/83438.
PubMed 42628030
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Intervention for Stress Reduction Among Young Adults
- ClinicalTrials.gov ID
- NCT06970652
- Acronym / sponsor ID
- 2023-0338-PHHP
- Conditions
- Stress, Resilience, Quality of Life, Depressive Symptoms, Anxiety, Sleep
- Keywords
- virtual reality, young adults, stress, stress management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- City University of New York, School of Public HealthUniversity, hospital or other
- Collaborators
- MindCo Health
- Study start
- 12 Oct 2023 (actual)
- Primary completion
- 21 May 2024 (actual)
- Study completion
- 21 May 2024 (actual)
- First posted
- 14 May 2025 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Intervention | Experimental | Device: virtual realityMindCo Relief, a mobile VR-based stress management application |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Participating in other stress reduction programs
- With photosensitive epilepsy for safety reasons.
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 |
|---|---|---|
| virtual realityParticipants 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. | Device | Intervention |
Primary outcome
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
7 secondary outcomes
Resilience
Time frame: From enrollment to the end of treatment at 8 weeks
Anxiety
Time frame: From enrollment to the end of treatment at 8 weeks
Depressive symptom
Time frame: From enrollment to the end of treatment at 8 weeks
Quality of Life
Time frame: From enrollment to the end of treatment at 8 weeks
Physical activity
Time frame: From enrollment to the end of treatment at 8 weeks
Sleep
Time frame: From enrollment to the end of treatment at 8 weeks
Objective stress
Time frame: First collection at baseline, second collection at 2 weeks after follow-up assessment was completed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Derived from this study: PubMed 42628030Hong H, Lootens MR, Bachman R, Olivera Leon LD, Dunlap AF, Goldenhersch E, Rosencovich N, Waitman C, Wyka KE, Huang TT. A Mobile Virtual Reality-Based Intervention for Stress Reduction Among Young Adults: Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2026 Aug 21;14:e83438. doi: 10.2196/83438.
- Individual participant dataSharing planned: Yes. All data will be available upon reasonable request.
Related trials for Stress
Recruiting
Stress Modulation and Dynamic Balance
Stress
Recruiting
A Clinical Trial to Evaluate the Effects of Adrenal Adapt on Sleep Quality, Daytime Energy, Stress Resilience, and Cognitive Performance.
Improves Daytime Energy Levels, Reduces Afternoon Energy Crashes and Midday Fatigue
RecruitingPhase 1
Rehabilitation Through Virtual Immersion & Integrated Exposure for Mild Traumatic Brain Injury (ReVIVE for mTBI)
Traumatic Brain Injuries, TBI (Traumatic Brain Injury)
RecruitingPhase 1
Study of Preoperative Radiation Therapy in Participants With Resectable Recurrent Abdominal Adrenocortical Carcinoma
Adrenocortical Carcinoma (ACC), Recurrent Adrenocortical Carcinoma (ACC)
Recruiting
Randomized Trial of Tele Vs. Clinic TF-CBT in Puerto Rico
Post-Traumatic Stress Disorder
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing virtual reality in people with Stress and Resilience, run by City University of New York, School of Public Health 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 5 inclusion and 2 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: finished, as of the sponsor's last update on 12 Jun 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Perceived Stress (time frame: From enrollment to the end of treatment at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06970652, which also lists 1 linked publication.
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 12 Jun 2025.