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

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.

Study Overview

• Status: Completed
• Conditions: Depression; Anxiety Disorders; Stress; Social Isolation; COVID-19 Pandemic Psychological Impact
• Intervention / Treatment: Behavioral: COVID Feel Good VR Self-Help Protocol; Other: Waiting Period

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Lombardia
    • Milano, Lombardia, Italy, 20145
      • IRCCS Istituto Auxologico Italiano

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VR Self-Help Protocol; Participants in this arm receive the 7-day COVID Feel Good self-help protocol immediately upon enrollment. The intervention consists of daily exposure to the 'Secret Garden' 360° VR video combined with specific daily cognitive and social exercises. Participants use a VR headset compatible with the Cardboard format to experience the 10-minute VR video once per day for 7 consecutive days, followed by completing the daily exercise with a partner.	Behavioral: COVID Feel Good VR Self-Help Protocol; The intervention consists of a 7-day self-help protocol based on daily exposure to 'The Secret Garden' 360° VR video (10 minutes per day) available at www.covidfeelgood.com, combined with different daily cognitive and social exercises. Participants use a smartphone with VR headset compatible with the Cardboard format. Each day's exercise addresses different psychological aspects: fighting rumination, awakening self-esteem, autobiographical memory, sense of community, goals and dreams, empathy, and planning for change. Exercises are designed to be performed individually and then discussed with a partner.
Other: Waiting List Control; Participants in this arm are placed on a waiting list for 7 days before receiving the intervention. During this waiting period, they complete the same baseline assessments as the experimental group but do not receive any specific intervention. After the 7-day waiting period, these participants then receive the same 7-day VR self-help protocol.	Other: Waiting Period; Participants in the control group initially undergo a 7-day waiting period before receiving the VR self-help protocol. During this period, they complete the same baseline assessments as the experimental group but do not receive any specific intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in depression, anxiety, and stress levels as measured by Depression Anxiety Stress Scale (DASS-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.	Baseline (Day -7 and Day 0), Post-intervention (Day 7), and 2-week Follow-up (Day 21)
Perceived Stress Scale (PSS-10)	A scale measuring subjective perception of stress during the past week	Baseline (Day -7 and Day 0), Post-intervention (Day 7), and Follow-up (Day 21)
Change in hopelessness levels	A scale measuring pessimistic attitudes toward the future	Baseline (Day -7 and Day 0), Post-intervention (Day 7), and Follow-up (Day 21)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Istituto Auxologico Italiano
• Collaborators: University of Bergen; Catholic University of the Sacred Heart; University of Liege; University of Barcelona; University of Tsukuba; Konkuk University; Clemson University (Virtual Reality and Nature Lab)

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Actual): October 1, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: February 26, 2025
• First Submitted That Met QC Criteria: February 26, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 26, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Relaxation; Virtual Reality; Simulation; Nature; Social Connectedness; Self-help Mental Health; Pandemic Coping
• Additional Relevant MeSH Terms: Mental Disorders; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19; Anxiety Disorders
• Other Study ID Numbers: 39C001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No