COVID Feel Good-An Easy Self-Help Virtual Reality Protocol to Overcome the Psychological Burden of Coronavirus
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Istituto Auxologico Italiano
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Change in hopelessness levels
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
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.
Intervention: COVID Feel Good VR Self-Help Protocol (Behavioral)
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.
Intervention: Waiting Period (Other)
Outcomes
Primary Outcomes
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
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.
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
Secondary Outcomes
- 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))