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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06295185
• Other study ID #: AJOUIRB-IV-2024-097
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: July 1, 2024

Study information

• Verified date: March 2024
• Source: Ajou University School of Medicine
• Contact: Yong Hyuk Choi, MD
• Phone: +82-31-219-5182
• Email: brainist.cho[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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'.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: July 1, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Mental Health Issue

Intervention

Other:
• application MARO
It is a mental healthcare application aim to improve mental health.
• Sham application
It is a sham application in order to control spill over bias.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ajou University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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