NCT06970652

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 12, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 21, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 21, 2024

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 14, 2025

Completed
Last Updated

June 12, 2025

Status Verified

April 1, 2025

Enrollment Period

7 months

First QC Date

May 6, 2025

Last Update Submit

June 9, 2025

Conditions

Keywords

virtual realityyoung adultsstressstress management

Outcome Measures

Primary Outcomes (1)

  • 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

    From enrollment to the end of treatment at 8 weeks

Secondary Outcomes (7)

  • Resilience

    From enrollment to the end of treatment at 8 weeks

  • Anxiety

    From enrollment to the end of treatment at 8 weeks

  • Depressive symptom

    From enrollment to the end of treatment at 8 weeks

  • Quality of Life

    From enrollment to the end of treatment at 8 weeks

  • Physical activity

    From enrollment to the end of treatment at 8 weeks

  • +2 more secondary outcomes

Study Arms (2)

Control

NO INTERVENTION

Intervention

EXPERIMENTAL

MindCo Relief, a mobile VR-based stress management application

Device: virtual reality

Interventions

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.

Intervention

Eligibility Criteria

Age18 Years - 29 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CUNY SPH

New York, New York, 10025, United States

Location

MeSH Terms

Conditions

DepressionAnxiety DisordersMotor Activity

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2025

First Posted

May 14, 2025

Study Start

October 12, 2023

Primary Completion

May 21, 2024

Study Completion

May 21, 2024

Last Updated

June 12, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

All data will be available upon reasonable request.

Locations