Development and Feasibility of a Metaverse-based Blended Online Intervention to Prevent Employees' Depression

Depression and Suicide Clinical Trial

Official title:

Development and Feasibility of a Metaverse-based Blended Online Intervention to Prevent Employees' Depression: Applying Intervention Mapping

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06426342
• Other study ID #: Mindguide_Employee
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 30, 2024
• Est. completion date: February 28, 2025

Study information

• Verified date: May 2024
• Source: Ewha Womans University
• Contact: Suk-Sun Kim, PhD
• Phone: +82-2-3277-2885
• Email: suksunkim[@]ewha.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: February 28, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 42 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depression and Suicide
• Depressive Disorder
• Suicide

Intervention

Behavioral:
• metaverse-based blended online intervention
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ewha Womans University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment	Recruitment will be assessed by the number of potentially eligible participants enrolled.	Initial (before intervention)
Primary	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.	Initial(before intervention), at 5 weeks after intervention.
Primary	Acceptability	Acceptability refers to how participants perceive and feel about the intervention and its components (Ayala & Elder, 2011; Sekhon et al., 2017). A 13- item questionnaire was developed based on the Client Satisfaction Questionnaire (CSQ) (Larsen et al., 1979; Sveen et al., 2021) 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).	at 5 weeks after intervention.
Secondary	Depression scale	The Center for Epidemiological Studies Depression Scale (CES-D; Radloff, 1977; Chon et al., 2001) 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.	Initial(before intervention), at 5 weeks after intervention.
Secondary	Positive and Negative Affect Schedule	Positive and Negative Affect Schedule (PANAS; Watson et al., 1988; Park & Lee, 2016) 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.	Initial(before intervention), at 5 weeks after intervention.
Secondary	Satisfaction with Life Scale	the Satisfaction with Life Scale (SWLS; Diener et al., 1985; Lim et al., 2010) 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.	Initial(before intervention), at 5 weeks after intervention.
Secondary	Burnout assessment tool	Burnout assessment tool (BAT; Schaufeli et al., 2020; Cho, 2020) with 23 items will be used to measure burnout including four core burnout symptoms: Exhaustion, Mental Distance, Emotional Impairment, and Cognitive Impairment. Exhaustion is the loss of physical and mental energy. Mental distance refers to psychological distancing from work or people at work. Emotional impairment is emotional reactions, such as frustration and irritability, brought on by burnout; and Cognitive impairmentthe is memory problems, attention and concentration deficits and poor cognitive performance.	Initial(before intervention), at 5 weeks after intervention.
Secondary	Sleep Quality scale	Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 1989; Sohn, 2012) 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	Initial(before intervention), at 5 weeks after intervention.