COVID-19 Pandemic Psychological Impact, Stress, Anxiety Disorders, Depression, Social Isolation
Conditions
Keywords
Virtual Reality, Self-help Mental Health, Relaxation, Social Connectedness, Pandemic Coping, Nature, Simulation
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.
Interventions
BEHAVIORALCOVID 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.
OTHERWaiting 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.
Sponsors
Clemson University (Virtual Reality and Nature Lab)
University of Barcelona
University of Tsukuba
Konkuk University
University of Bergen
University of Liege
Catholic University of the Sacred Heart
Istituto Auxologico Italiano
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 subjective distress during intervention | Daily during intervention (Days 1-7) | A scale measuring level of perceived distress |
| 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 |
Countries
Italy
Outcome results
None listed