COVID Feel Good-An Easy Self-Help Virtual Reality Protocol to Overcome the Psychological Burden of Coronavirus

Not Applicable

Completed

• Conditions: COVID-19 Pandemic Psychological Impact; Stress; Anxiety Disorders; Depression; Social Isolation

• Registration Number: NCT06850376
• Lead Sponsor: Istituto Auxologico Italiano

Brief Summary

This pragmatic trial aims to evaluate whether a weekly self-help virtual reality protocol can help overcome the psychological burden of the COVID-19 pandemic. The protocol is based on 'The Secret Garden' 360° VR video available online (www.covidfeelgood.com) which simulates a natural environment to promote relaxation and self-reflection. The VR experience is combined with daily cognitive and social exercises designed to facilitate critical examination of personal identity, relationships, and coping strategies. The study assesses whether this intervention can reduce anxiety, depression, perceived stress, and hopelessness while improving well-being and social connectedness during pandemic-related restrictions.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-01
• Primary Completion: 2021-10-01
• Study Completion: 2021-12-31
• Status Verified: 2025-02
• Study First Submitted: 2025-02-26
• Study First Submitted QC: 2025-02-26
• Last Update Submitted: 2025-02-26
• Study First Posted: 2025-02-27
• Last Update Posted: 2025-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Adult participants (≥18 years)
• Native speakers of the country where they will be enrolled
• Have experienced at least two months of quarantine or isolation related to the coronavirus pandemic
• Provide full, written, informed consent
• Have the availability of a smartphone and a cardboard VR headset
• Availability and agreement of a partner for conducting the self-help component of the treatment

Exclusion Criteria

• Visual or hearing impairments that can limit the participation in the protocol
• Participants reporting vestibular and/or balance disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in depression, anxiety, and stress levels as measured by Depression Anxiety Stress Scale (DASS-21)	Baseline (Day -7 and Day 0), Post-intervention (Day 7), and 2-week Follow-up (Day 21)	The Depression Anxiety Stress Scale (DASS-21) is a self-report questionnaire consisting of 21 items divided into three subscales that measure depression, anxiety, and perceived stress. Each subscale can be computed individually or added together into a score for general distress. Higher scores indicate greater symptoms of depression, anxiety, and stress. The scale will be used to assess changes in psychological distress associated with the COVID-19 pandemic before and after the VR self-help intervention.
Perceived Stress Scale (PSS-10)	Baseline (Day -7 and Day 0), Post-intervention (Day 7), and Follow-up (Day 21)	A scale measuring subjective perception of stress during the past week
Change in hopelessness levels	Baseline (Day -7 and Day 0), Post-intervention (Day 7), and Follow-up (Day 21)	A scale measuring pessimistic attitudes toward the future

Secondary Outcome Measures

Name	Time	Method
Change in social connectedness	Baseline (Day -7 and Day 0), Post-intervention (Day 7), and 2-week Follow-up (Day 21)	A scale measuring sense of connection to others and to the social context
Change in fear of coronavirus	Baseline (Day -7 and Day 0), Post-intervention (Day 7), and Follow-up (Day 21)	A scale measuring level of fear related to the COVID-19 pandemic
Change in relaxation levels during intervention	Daily during intervention (Days 1-7)	A scale measuring relaxation and perceived stress during the intervention
Change in subjective distress during intervention	Daily during intervention (Days 1-7)	A scale measuring level of perceived distress

Trial Locations

Locations (1)

IRCCS Istituto Auxologico Italiano; 🇮🇹 Milano, Lombardia, Italy