- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06426342
Development and Feasibility of a Metaverse-based Blended Online Intervention to Prevent Employees' Depression
Development and Feasibility of a Metaverse-based Blended Online Intervention to Prevent Employees' Depression: Applying Intervention Mapping
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Seoul, Korea, Republic of, 03760
- Ewha Womans University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Mindguide_employee
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Recruitment
Time Frame: baseline
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Recruitment will be assessed by the number of potentially eligible participants enrolled.
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baseline
|
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The retention rate
Time Frame: Baseline, at 5 weeks after intervention.
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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.
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Baseline, at 5 weeks after intervention.
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Acceptability
Time Frame: at 5 weeks after intervention.
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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).
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at 5 weeks after intervention.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Depression scale
Time Frame: Baseline, at 5 weeks after intervention.
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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.
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Baseline, at 5 weeks after intervention.
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Positive and Negative Affect Schedule
Time Frame: Baseline, at 5 weeks after intervention.
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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.
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Baseline, at 5 weeks after intervention.
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Satisfaction with Life Scale
Time Frame: Baseline, at 5 weeks after intervention.
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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.
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Baseline, at 5 weeks after intervention.
|
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Sleep Quality scale
Time Frame: Baseline, at 5 weeks after intervention.
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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. |
Baseline, at 5 weeks after intervention.
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Burnout assessment tool
Time Frame: Baseline, at 5 weeks after intervention.
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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 |
Baseline, at 5 weeks after intervention.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Suk-Sun Kim, PhD, Ewha Womans Univeristy
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Mindguide_Employee
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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