## Protocol Section
### Identification Module
**NCT ID:** NCT06426342

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

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

#### Organization Study ID Info
**ID:** Mindguide_Employee
#### Organization
**Class:** OTHER
**Full Name:** Ewha Womans University
### Status Module
#### Completion Date
**Date:** 2025-02-28

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-20

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-07-30

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Ewha Womans University

#### Responsible Party

**Investigator Affiliation:** Ewha Womans University

**Investigator Full Name:** Suk-Sun Kim, PhD. MSN. RN

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief 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.

### Conditions Module

**Conditions:**

- Depression and Suicide

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 140

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Behavioral: metaverse-based blended online intervention

**Label:** Mindguide_employee

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Mindguide_employee

**Description:** 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.

**Name:** metaverse-based blended online intervention

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** Recruitment will be assessed by the number of potentially eligible participants enrolled.

**Measure:** Recruitment

**Time Frame:** Initial (before intervention)

**Description:** 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.

**Measure:** The retention rate

**Time Frame:** Initial(before intervention), at 5 weeks after intervention.

**Description:** 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).

**Measure:** Acceptability

**Time Frame:** at 5 weeks after intervention.

#### Secondary Outcomes

**Description:** 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.

**Measure:** Depression scale

**Time Frame:** Initial(before intervention), at 5 weeks after intervention.

**Description:** 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.

**Measure:** Positive and Negative Affect Schedule

**Time Frame:** Initial(before intervention), at 5 weeks after intervention.

**Description:** 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.

**Measure:** Satisfaction with Life Scale

**Time Frame:** Initial(before intervention), at 5 weeks after intervention.

**Description:** 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.

**Measure:** Burnout assessment tool

**Time Frame:** Initial(before intervention), at 5 weeks after intervention.

**Description:** 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

**Measure:** Sleep Quality scale

**Time Frame:** Initial(before intervention), at 5 weeks after intervention.

### Eligibility Module

**Eligibility Criteria:** 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.

**Healthy Volunteers:** True

**Maximum Age:** 42 Years

**Minimum Age:** 20 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** suksunkim@ewha.ac.kr

**Name:** Suk-Sun Kim, PhD

**Phone:** +82-2-3277-2885

**Role:** CONTACT

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001526

- Term: Behavioral Symptoms

- ID: D000019964

- Term: Mood Disorders

- ID: D000001523

- Term: Mental Disorders

- ID: D000016728

- Term: Self-Injurious Behavior

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M7058

- Name: Depression

- Relevance: HIGH

- As Found: Depression

- ID: M7061

- Name: Depressive Disorder

- Relevance: HIGH

- As Found: Depression

- ID: M16191

- Name: Suicide

- Relevance: HIGH

- As Found: Suicide

- ID: M4818

- Name: Behavioral Symptoms

- Relevance: LOW

- As Found: Unknown

- ID: M21835

- Name: Mood Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M19089

- Name: Self-Injurious Behavior

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003863

- Term: Depression

- ID: D000003866

- Term: Depressive Disorder

- ID: D000013405

- Term: Suicide

### Misc Info Module

- Version Holder: 2024-05-31
