Depression and Suicide IdeationNCT06426342
Development and Feasibility of a Metaverse-based Blended Online Intervention to Prevent Employees' Depression
A study testing metaverse-based blended online intervention in people with Depression and Suicide Ideation, run by Ewha Womans University at 1 site in South Korea.
Trial summary
The goal of this feasibility study is to develop a new metaverse-based blended online intervention using an online program and coaching via metaverse to prevent depression among Generation MZ Employees in South Korea. Read more about this study
- Who is it for?
- Ages 20 to 42 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression and Suicide Ideation
- What is being tested?
- metaverse-based blended online intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Jan 2025to 7 Apr 2025
- 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 20 to 42 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Generation MZ Employees of South Korea who are aged between 20 and 42; Millennials were born between 1981 to 1996, and Generation Zs were born between 1997 to 2004
Who cannot join
- 1) being unemployed or having less than 1 year job experience,
- 2) having mental disorders such as schizophrenia or substance abuse (as this is a preventive intervention) and currently attending other mental health therapy to avoid mixing effects.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Feasibility of a Metaverse-based Blended Online Intervention to Prevent Employees' Depression: Applying Intervention Mapping
The goal of this feasibility study is to develop a new metaverse-based blended online intervention using an online program and coaching via metaverse to prevent depression among Generation MZ Employees in South Korea. In addition, this study primarily explores reach and acceptability and secondarily evaluates the preliminary effectiveness of this preventive intervention on Korea's Gen MZ Employees.
- Conditions
- Depression and Suicide Ideation
- Being tested
- metaverse-based blended online intervention
- Keywords
- depression, Employee, Preventive Health Program, Digital Health, Suicide
- Medical subject headings
- Depression, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metaverse-based blended online interventionBehavioural
A new metaverse-based blended online intervention was developed using an online program and coaching via metaverse to prevent depression among Generation MZ Employees in South Korea.
| Study group | Role | What they receive |
|---|---|---|
| Mindguide_employee | Experimental | Not described Receives: Behavioral: metaverse-based blended online intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
Recruitment will be assessed by the number of potentially eligible participants enrolled.
Measured: baseline
The retention rate
The retention rate will be calculated as the percentage of completion rates for the entire intervention and questionnaires until the completion of a 5 weeks after intervention.
Measured: Baseline, at 5 weeks after intervention.
Acceptability
Acceptability refers to how participants perceive and feel about the intervention and its components. A 13- item questionnaire was developed based on the Client Satisfaction Questionnaire to measure acceptability with three subcategories: helpfulness (three items), suitability (seven items), and satisfaction (three items). Participants responded on a 5- point Likert scale ranging from 1 (not at all) to 5 (very).
Measured: at 5 weeks after intervention.
Secondary outcomes (5)
Depression scale
The Center for Epidemiological Studies Depression Scale with 20- item will be used to measure depressive symptoms using a 4- point Likert scale. The total score ranges from 0 to 60, with higher scores indicating higher levels of depressive symptoms.
Measured: Baseline, at 5 weeks after intervention.
Positive and Negative Affect Schedule
Positive and Negative Affect Schedule will used to measure positive and negative affect using a 5- point Likert scale. The total score ranges from 10 to 50, with higher scores indicating a greater perception of positive affect or negative affect.
Measured: Baseline, at 5 weeks after intervention.
Satisfaction with Life Scale
the Satisfaction with Life Scale with 5- items will be used to assess life satisfaction using a 7- point Likert scale. The total score ranges from 5 to 35, with higher scores indicating greater life satisfaction.
Measured: Baseline, at 5 weeks after intervention.
Sleep Quality scale
Pittsburgh Sleep Quality Index with 19 items will be used to evaluate overall sleep quality. 19 self-reported items includes seven subcategories: subjective sleep quality, sleep latency, sleep duration, habitual sleep effi ciency, sleep disturbances, use of sleeping medication, and daytime dysfunction.
The total score ranges from 0 to 21, with higher scores indicating worse sleep quality.
Measured: Baseline, at 5 weeks after intervention.
Burnout assessment tool
Burnout assessment tool with 23 items will be used to measure burnout including four core burnout symptoms: Exhaustion, Mental Distance, Emotional Impairment, and Cognitive Impairment.
For each core scale, the average score is calculated by summing the scores of the items in that scale and dividing by the number of items in that scale.
Score Interpretation:
1.0 to 1.9: Very low or no burnout symptoms. 2.0 to 2.9: Mild burnout symptoms. 3.0 to 3.9: Moderate burnout symptoms. 4.0 to 5.0: Severe burnout symptoms
Measured: Baseline, at 5 weeks after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2024
- Study start5 Jan 2025
- Primary completion7 Apr 2025
- Study completion7 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression and Suicide IdeationStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ewha Womans University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suk-Sun Kim, PhD. MSN. RN, Ewha Womans University
- Investigators
- Suk-Sun Kim, PhD, Principal investigator, Ewha Womans Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06426342
- Sponsor's protocol ID
- Mindguide_Employee
- Status last verified
- Feb 2025
- First submitted
- 14 May 2024
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Feasibility of a Metaverse-based Blended Online Intervention to Prevent Employees' Depression: Applying Intervention Mapping
- ClinicalTrials.gov ID
- NCT06426342
- Acronym / sponsor ID
- Mindguide_Employee
- Conditions
- Depression and Suicide Ideation
- Keywords
- depression, Employee, Preventive Health Program, Digital Health, Suicide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Ewha Womans UniversityUniversity, hospital or other
- Study start
- 5 Jan 2025 (actual)
- Primary completion
- 7 Apr 2025 (actual)
- Study completion
- 7 Apr 2025 (actual)
- First posted
- 23 May 2024 (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.
The goal of this feasibility study is to develop a new metaverse-based blended online intervention using an online program and coaching via metaverse to prevent depression among Generation MZ Employees in South Korea. In addition, this study primarily explores reach and acceptability and secondarily evaluates the preliminary effectiveness of this preventive intervention on Korea's Gen MZ Employees.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mindguide_employee | Experimental | Behavioral: metaverse-based blended online intervention |
Who may qualify
- Ages
- 20 to 42 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Generation MZ Employees of South Korea who are aged between 20 and 42; Millennials were born between 1981 to 1996, and Generation Zs were born between 1997 to 2004
Key exclusion criteria (2 listed)
- 1) being unemployed or having less than 1 year job experience,
- 2) having mental disorders such as schizophrenia or substance abuse (as this is a preventive intervention) and currently attending other mental health therapy to avoid mixing effects.
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 |
|---|---|---|
| metaverse-based blended online interventionA new metaverse-based blended online intervention was developed using an online program and coaching via metaverse to prevent depression among Generation MZ Employees in South Korea. | Behavioural | Mindguide_employee |
Primary outcome
Recruitment
Time frame: baseline
Recruitment will be assessed by the number of potentially eligible participants enrolled.
The retention rate
Time frame: Baseline, at 5 weeks after intervention.
The retention rate will be calculated as the percentage of completion rates for the entire intervention and questionnaires until the completion of a 5 weeks after intervention.
Acceptability
Time frame: at 5 weeks after intervention.
Acceptability refers to how participants perceive and feel about the intervention and its components. A 13- item questionnaire was developed based on the Client Satisfaction Questionnaire to measure acceptability with three subcategories: helpfulness (three items), suitability (seven items), and satisfaction (three items). Participants responded on a 5- point Likert scale ranging from 1 (not at all) to 5 (very).
5 secondary outcomes
Depression scale
Time frame: Baseline, at 5 weeks after intervention.
Positive and Negative Affect Schedule
Time frame: Baseline, at 5 weeks after intervention.
Satisfaction with Life Scale
Time frame: Baseline, at 5 weeks after intervention.
Sleep Quality scale
Time frame: Baseline, at 5 weeks after intervention.
Burnout assessment tool
Time frame: Baseline, at 5 weeks after intervention.
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 8 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Suk-Sun Kim, PhD principal investigator
Ewha Womans Univeristy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing metaverse-based blended online intervention in people with Depression and Suicide Ideation, run by Ewha Womans University at 1 site in South Korea.
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 1 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 8 Aug 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 South Korea. 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?
Recruitment (time frame: baseline). 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 8 Aug 2025.