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| Name | Class |
|---|---|
| Clemson University (Virtual Reality and Nature Lab) | UNKNOWN |
| University of Barcelona | OTHER |
| University of Tsukuba | OTHER |
| Konkuk University |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in social connectedness | A scale measuring sense of connection to others and to the social context | Baseline (Day -7 and Day 0), Post-intervention (Day 7), and 2-week Follow-up (Day 21) |
| Change in fear of coronavirus |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Istituto Auxologico Italiano | Milan | Lombardy | 20145 | Italy |
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| OTHER |
| University of Bergen | OTHER |
| University of Liege | OTHER |
| Catholic University of the Sacred Heart | OTHER |
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.
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| 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. |
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A scale measuring level of fear related to the COVID-19 pandemic
| Baseline (Day -7 and Day 0), Post-intervention (Day 7), and Follow-up (Day 21) |
| Change in relaxation levels during intervention | A scale measuring relaxation and perceived stress during the intervention | Daily during intervention (Days 1-7) |
| Change in subjective distress during intervention | A scale measuring level of perceived distress | Daily during intervention (Days 1-7) |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| D012934 | Social Isolation |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D012919 | Social Behavior |
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