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Completed

NCT Number: NCT06850376

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.

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Key information

Conditions

COVID-19 Pandemic Psychological Impact Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Social Behavior Social Isolation Stress

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Istituto Auxologico Italiano

Milan, Lombardy, 20145, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in depression, anxiety, and stress levels as measured by Depression Anxiety Stress Scale (DASS-21)

    Time frame: 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.

  2. Perceived Stress Scale (PSS-10)

    Time frame: 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

  3. Change in hopelessness levels

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

    A scale measuring pessimistic attitudes toward the future

Secondary outcomes

  1. Change in social connectedness

    Time frame: 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

  2. Change in fear of coronavirus

    Time frame: 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

  3. Change in relaxation levels during intervention

    Time frame: Daily during intervention (Days 1-7)

    A scale measuring relaxation and perceived stress during the intervention

  4. Change in subjective distress during intervention

    Time frame: Daily during intervention (Days 1-7)

    A scale measuring level of perceived distress

Sponsors and collaborators

Lead sponsor

Istituto Auxologico Italiano

Other

Collaborators

  • Catholic University of the Sacred Heart
  • Clemson University (Virtual Reality and Nature Lab)
  • Konkuk University
  • University of Barcelona
  • University of Bergen
  • University of Liege
  • University of Tsukuba

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 27, 2025
Registry last updated
Feb 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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