COVID-19 Pandemic Psychological ImpactNCT06850376
COVID Feel Good-An Easy Self-Help Virtual Reality Protocol to Overcome the Psychological Burden of Coronavirus
A study testing COVID Feel Good VR Self-Help Protocol and Waiting Period in people with COVID-19 Pandemic Psychological Impact and Stress, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Pandemic Psychological Impact, Stress, Anxiety Disorders
- What is being tested?
- COVID Feel Good VR Self-Help Protocol and Waiting Period
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2020to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Visual or hearing impairments that can limit the participation in the protocol
- Participants reporting vestibular and/or balance disorders
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- COVID-19 Pandemic Psychological Impact, Stress, Anxiety Disorders, Depression, Social Isolation
- Being tested
- COVID Feel Good VR Self-Help Protocol, Waiting Period
- Keywords
- Virtual Reality, Self-help Mental Health, Relaxation, Social Connectedness, Pandemic Coping, Nature, Simulation
- Medical subject headings
- Anxiety Disorders, Depression, Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID Feel Good VR Self-Help ProtocolBehavioural
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 PeriodOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: COVID Feel Good VR Self-Help Protocol |
| 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. Receives: Other: Waiting Period |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: Baseline (Day -7 and Day 0), Post-intervention (Day 7), and Follow-up (Day 21)
Secondary outcomes (4)
Change in social connectedness
A scale measuring sense of connection to others and to the social context
Measured: Baseline (Day -7 and Day 0), Post-intervention (Day 7), and 2-week Follow-up (Day 21)
Change in fear of coronavirus
A scale measuring level of fear related to the COVID-19 pandemic
Measured: 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
Measured: Daily during intervention (Days 1-7)
Change in subjective distress during intervention
A scale measuring level of perceived distress
Measured: Daily during intervention (Days 1-7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start1 Apr 2020
- Primary completion1 Oct 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 Pandemic Psychological ImpactStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06850376
- Sponsor's protocol ID
- 39C001
- Status last verified
- Feb 2025
- First submitted
- 26 Feb 2025
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID Feel Good-An Easy Self-Help Virtual Reality Protocol to Overcome the Psychological Burden of Coronavirus
- ClinicalTrials.gov ID
- NCT06850376
- Acronym / sponsor ID
- 39C001
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Collaborators
- 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
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 27 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| VR Self-Help Protocol | Experimental | Behavioral: COVID Feel Good VR Self-Help ProtocolParticipants 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. |
| Waiting List Control | Other | Other: Waiting PeriodParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Visual or hearing impairments that can limit the participation in the protocol
- Participants reporting vestibular and/or balance disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID Feel Good VR Self-Help ProtocolThe 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. | Behavioural | VR Self-Help Protocol |
| Waiting PeriodParticipants 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. | Other | Waiting List Control |
Primary outcome
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
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
4 secondary outcomes
Change in social connectedness
Time frame: Baseline (Day -7 and Day 0), Post-intervention (Day 7), and 2-week Follow-up (Day 21)
Change in fear of coronavirus
Time frame: Baseline (Day -7 and Day 0), Post-intervention (Day 7), and Follow-up (Day 21)
Change in relaxation levels during intervention
Time frame: Daily during intervention (Days 1-7)
Change in subjective distress during intervention
Time frame: Daily during intervention (Days 1-7)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COVID Feel Good VR Self-Help Protocol and Waiting Period in people with COVID-19 Pandemic Psychological Impact and Stress, run by Istituto Auxologico Italiano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.