Digital Therapeutic Workplace Technology as a Employee Management Tool and Employee's Mental Health Care

How Social Ventures Boost Performance and Sustain Businesses With Digital Therapeutic Workplace Technology (Smartphone App 'Maro') Designed to Support Individual Employee's Mental Health

The purpose of the study is to determine whether a digital healthcare app for employee's mental health can effectively improve the mental health of Hisbeans's employees and the managerial performance of Hisbeans, which is represented as a 'social enterprise'.

Study Overview

• Status: Not yet recruiting
• Conditions: Depression; Mental Health Issue
• Intervention / Treatment: Other: application MARO; Other: Sham application

Detailed Description

Hisbeans is a social enterprise where employees are consist of individual with mental disabilities.

'Hisbeans' employees(N = 150 subjects) will be randomly assigned to Group 1 (maro intervention), or Group 2 (control app intervention) by cluster randomization depending on the branch of the company.

• MARO intervention group: MARO (mental health digital application) use
• Control group: sham app use

The intervention period will be 8weeks.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yong Hyuk Choi, MD; Phone Number: +82-31-219-5182; Email: brainist.cho@gmail.com
• Study Contact Backup: Name: Anna You; Phone Number: +82-31-219-4696; Email: uanna@ajou.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. HISBEANS store employees
2. Age: 18 years old or older
3. possessing a smartphone with internet connection
4. subjects agree to participate in the study

Exclusion Criteria:

1. Those who have symptoms of psychotic disorder are acutely active or advanced, making clinical intervention difficult
2. Those who has been started or changed their antidepressant medication within the last 1 month or cannot be maintained stably during the intervention period
3. Those who are non-literate
4. Those who have used the Maro app previously
5. Those who couldn't use Maro app in their own smartphone
6. Those who participate in another intervention study
7. Those who have a serious medical condition that prevents them from participating in the intervention and efficacy evaluation
8. Those who is unable to participate fully and cooperatively by the judgment of the researcher

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: mental health treated with digital intervention app 'Maro'; Intervention group will use 'Maro app' which was developed to improve mental health for 8weeks. Through 8weeks intervention group will record their status more than once a day and utilize specific functions in the app. They will also have meetings once a week in the online chat in order to share their own experience about Maro application use with other employees in the same branch.	Other: application MARO; It is a mental healthcare application aim to improve mental health.
Sham Comparator: Digital Sham App; Control group will use Sham app for 8weeks.	Other: Sham application; It is a sham application in order to control spill over bias.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in network on the Standard Name Generator Approach scale	Description: A validated self-reported list of names assessing the subject's network scores; minimum and maximum values: from no name to the maximum available subject employees in the focal company that subject employees work for; score meaning: an individual subject generating more names means he or she has more connected people in the company	4weeks, 8weeks after starting treatment
Change in depression symptoms severity on the Patient Health Questionnaire-9	Description: Validated self-reported questionnaire assessing the severity of depression symptom; minimum and maximum values: 9-item scale with total scores between 0 and 27; score meaning: higher scores indicate greater symptoms severity	4weeks, 8weeks after starting treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in social capital on the Social Capital Scale	Description: Based on the validated self-reported name assessing the person's network scores, researchers calculate the inverse degree to which individuals hold less constraints in the network landscape; minimum and maximum values: a scale between 0 and 1 multiplied by the number of subjects individuals; score meaning: higher scores indicate greater social capital	4weeks, 8weeks after starting treatment
Change in perceived workload on the Perceived Workload Scale	Description: Validated self-reported questionnaire assessing the complexity of jobs and the work-related stress; minimum and maximum values: a 4-item scale with total scores between 0 and 28; score meaning: higher scores indicate greater perceived workload	4weeks, 8weeks after starting treatment
Change in job self-efficacy on the Job Self-Efficacy Scale	Description: Validated self-reported questionnaire assessing the efficacy of one's job and tasks; minimum and maximum values: a 11-item scale with total scores between 0 and 77; score meaning: higher scores indicate greater job self-efficacy	4weeks, 8weeks after starting treatment
Change in sense of meaningfulness for job on the Sense of Meaningfulness for Job Scale	Description: Validated self-reported questionnaire assessing the sense of meaningfulness toward one's job; minimum and maximum values: a 6-item scale with total scores between 0 and 42; score meaning: higher scores indicate greater sense of meaningfulness for job	4weeks, 8weeks after starting treatment
Change in work orientation toward his or her job on the Work Orientation Scale	Description: Validated self-reported questionnaire assessing one's work orientation toward his or her job; minimum and maximum values: categorical values among 'economic-value group', 'achievement group', and 'calling group'; score meaning: one sorting into a certain categorical value means one such	4weeks, 8weeks after starting treatment
Change in sense of psychological safety on the Perception of Psychological Safety Scale of Company Employees	Description: Validated self-reported questionnaire assessing one's perception of psychological safety within the company; minimum and maximum values: a 7-item scale with average scores between 0 and 7; score meaning: higher scores indicate greater sense of psychological safety	4weeks, 8weeks after starting treatment
Change in firm performance on the Company weekly sales records	Description: Validated objective measure of firm's performance assessing the department's weekly revenue; minimum and maximum values: a monetary scale between 0 and possibly generatable revenue during firm's operation time; score meaning: higher sales indicate greater firm performance	4weeks, 8weeks after starting treatment
Change in amsenteeism/leaves on the absenteeism/leave scales for employees with severe mental disabilities	Description: Validated numeric, objective measure assessing the individual employees' absenteeism or turnover cases, among which we also measure the employees with severe mental disabilities.; minimum and maximum values: the number of individuals scale between 0 and the maximum possible employees working for the firm.; score meaning: higher number indicates greater amsenteeism/leaves	4weeks, 8weeks after starting treatment
Change in stress regulation skill on the Emotional/Cognitive/Behavioral State Questionnaire	Description: self-reported questionnaire assessing stress regulation skill; minimum and maximum values: 3-item scale with total scores between 3 and 30; score meaning: higher scores indicate greater stress regulation skill	4weeks, 8weeks after starting treatment
Change in anxiety symptoms severity on the General Anxiety Disorder-7items scale	Description: Validated self-reported questionnaire assessing the severity of anxiety symptom; minimum and maximum values: 7-item scale with total scores between 0 and 21; score meaning: higher scores indicate greater symptoms severity	4weeks, 8weeks after starting treatment
Change in perceived stress level on the Perceived Stress Scale	Description: Validated self-reported questionnaire assessing perceived stress; minimum and maximum values: 10 scale with total scores between 0 and 40; score meaning: higher scores indicate greater perceived stress	4weeks, 8weeks after starting treatment
Change in social functioning on Social Adaptation Self Rating Scale	Description: Validated self-reported questionnaire assessing social motivation and behavior; minimum and maximum values: 21-item scale with total scores between 21 and 84; score meaning: higher scores indicate greater social functioning	4weeks, 8weeks after starting treatment
Change in positive psychological capital on Korean version of Positive Psychological Capital Scale	Description: Validated self-reported questionnaire assessing positive psychological capital, which consist of self-efficacy, hope, optimism, and resilience; minimum and maximum values: 18-item scale with total scores between 18 and 90; score meaning: higher scores indicate greater Positive Psychological Capital	4weeks, 8weeks after starting treatment
Change in Organizational Companionship on Organizational Culture Inventory	Description: Validated self-reported questionnaire assessing Organizational Companionship; minimum and maximum values: 28-item scale with total scores between 28 and 196; score meaning: higher scores indicate a higher degress of organizational companionship	4weeks, 8weeks after starting treatment
Change in individual's social network on Lubben Social Network Scale-18	Description: Validated self-reported questionnaire assessing an individual's social network of relatives, friends, and neighbors.; minimum and maximum values: 18-item scale with total scores between 0 and 90; score meaning: higher scores indicate a larger social network	4weeks, 8weeks after starting treatment

Collaborators and Investigators

• Sponsor: Ajou University School of Medicine
• Investigators: Principal Investigator: Chang Hyung Hong, Ph.D, Ajou Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: February 16, 2024
• First Submitted That Met QC Criteria: March 3, 2024
• First Posted (Actual): March 6, 2024

Study Record Updates

• Last Update Posted (Actual): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 3, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: AJOUIRB-IV-2024-097

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No