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

NCT06850376 | Completed

• 1 other identifier: 39C001
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Virtual Reality; Self-help Mental Health; Relaxation; Social Connectedness; Pandemic Coping; Nature; Simulation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Change in social connectedness

  Baseline (Day -7 and Day 0), Post-intervention (Day 7), and 2-week Follow-up (Day 21)

• Change in fear of coronavirus

  Baseline (Day -7 and Day 0), Post-intervention (Day 7), and Follow-up (Day 21)

• Change in relaxation levels during intervention

  Daily during intervention (Days 1-7)

• Change in subjective distress during intervention

  Daily during intervention (Days 1-7)

Study Arms (2)

VR Self-Help Protocol

EXPERIMENTAL

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

Waiting List Control

OTHER

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

Interventions

COVID Feel Good VR Self-Help Protocol BEHAVIORAL

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.

VR Self-Help Protocol

Waiting Period OTHER

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.

Waiting List Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

IRCCS Istituto Auxologico Italiano

Milan, Lombardy, 20145, Italy

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression; Social Isolation

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Social Behavior

Study Design

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

Model Details: Participants are randomly assigned to either an experimental group receiving the 7-day VR self-help protocol immediately, or a waiting-list control group that receives the intervention after the initial waiting period.

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: February 27, 2025
• Study Start: April 1, 2020
• Primary Completion: October 1, 2021
• Study Completion: December 31, 2021
• Last Updated: February 27, 2025

Record last verified: 2025-02

Locations

IT (1)