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Completed

NCT Number: NCT06295185

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

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'.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Mental Health Issue

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ajou Medical University

Suwon, 16499, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • HISBEANS store employees
  • Age: 18 years old or older
  • possessing a smartphone with internet connection
  • subjects agree to participate in the study

Exclusion criteria

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

Treatment and study plan

application MARO

Other

It is a mental healthcare application aim to improve mental health.

Sham application

Other

It is a sham application in order to control spill over bias.

Primary outcomes

  1. Change in network on the Standard Name Generator Approach scale

    Time frame: 4weeks, 8weeks after starting treatment

    • 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

  2. Change in depression symptoms severity on the Patient Health Questionnaire-9

    Time frame: 4weeks, 8weeks after starting treatment

    • 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

Secondary outcomes

  1. Change in social capital on the Social Capital Scale

    Time frame: 4weeks, 8weeks after starting treatment

    • 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

  2. Change in perceived workload on the Perceived Workload Scale

    Time frame: 4weeks, 8weeks after starting treatment

    • 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

  3. Change in job self-efficacy on the Job Self-Efficacy Scale

    Time frame: 4weeks, 8weeks after starting treatment

    • 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

  4. Change in sense of meaningfulness for job on the Sense of Meaningfulness for Job Scale

    Time frame: 4weeks, 8weeks after starting treatment

    • 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

  5. Change in work orientation toward his or her job on the Work Orientation Scale

    Time frame: 4weeks, 8weeks after starting treatment

    • 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

  6. Change in sense of psychological safety on the Perception of Psychological Safety Scale of Company Employees

    Time frame: 4weeks, 8weeks after starting treatment

    • 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

  7. Change in firm performance on the Company weekly sales records

    Time frame: 4weeks, 8weeks after starting treatment

    • 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

  8. Change in amsenteeism/leaves on the absenteeism/leave scales for employees with severe mental disabilities

    Time frame: 4weeks, 8weeks after starting treatment

    • 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

  9. Change in stress regulation skill on the Emotional/Cognitive/Behavioral State Questionnaire

    Time frame: 4weeks, 8weeks after starting treatment

    • 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

  10. Change in anxiety symptoms severity on the General Anxiety Disorder-7items scale

    Time frame: 4weeks, 8weeks after starting treatment

    • 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

  11. Change in perceived stress level on the Perceived Stress Scale

    Time frame: 4weeks, 8weeks after starting treatment

    • 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

  12. Change in social functioning on Social Adaptation Self Rating Scale

    Time frame: 4weeks, 8weeks after starting treatment

    • 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

  13. Change in positive psychological capital on Korean version of Positive Psychological Capital Scale

    Time frame: 4weeks, 8weeks after starting treatment

    • 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

  14. Change in Organizational Companionship on Organizational Culture Inventory

    Time frame: 4weeks, 8weeks after starting treatment

    • 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

  15. Change in individual's social network on Lubben Social Network Scale-18

    Time frame: 4weeks, 8weeks after starting treatment

    • 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

Sponsors and collaborators

Lead sponsor

Ajou University School of Medicine

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 6, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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