Clinical trial NCT06850376: COVID Feel Good-An Easy Self-Help Virtual Reality Protocol to Overcome the Psychological Burden of Coronavirus
Official title: COVID Feel Good-An Easy Self-Help Virtual Reality Protocol to Overcome the Psychological Burden of Coronavirus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
Collaborators: name: Clemson University (Virtual Reality and Nature Lab)
name: University of Barcelona
name: University of Tsukuba
name: Konkuk University
name: University of Bergen
name: University of Liege
name: Catholic University of the Sacred Heart
First posted: 2025-02-27
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in depression, anxiety, and stress levels as measured by Depression Anxiety Stress Scale (DASS-21)
timeFrame: Baseline (Day -7 and Day 0), Post-intervention (Day 7), and 2-week Follow-up (Day 21)
measure: Perceived Stress Scale (PSS-10)
timeFrame: Baseline (Day -7 and Day 0), Post-intervention (Day 7), and Follow-up (Day 21)
measure: Change in hopelessness levels
timeFrame: Baseline (Day -7 and Day 0), Post-intervention (Day 7), and Follow-up (Day 21)
Secondary outcomes:
measure: Change in social connectedness
timeFrame: Baseline (Day -7 and Day 0), Post-intervention (Day 7), and 2-week Follow-up (Day 21)
measure: Change in fear of coronavirus
timeFrame: Baseline (Day -7 and Day 0), Post-intervention (Day 7), and Follow-up (Day 21)
measure: Change in relaxation levels during intervention
timeFrame: Daily during intervention (Days 1-7)
measure: Change in subjective distress during intervention
timeFrame: Daily during intervention (Days 1-7)
Other outcomes:
Locations:
city: Milano
country: Italy
facility: IRCCS Istituto Auxologico Italiano
state: Lombardia
Study officials:
References: