Clinical trial NCT06295185: Digital Therapeutic Workplace Technology as a Employee Management Tool and Employee's Mental Health Care
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Mental Health Issue
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2024-03-06
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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'.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in network on the Standard Name Generator Approach scale
timeFrame: 4weeks, 8weeks after starting treatment
measure: Change in depression symptoms severity on the Patient Health Questionnaire-9
timeFrame: 4weeks, 8weeks after starting treatment
Secondary outcomes:
measure: Change in social capital on the Social Capital Scale
timeFrame: 4weeks, 8weeks after starting treatment
measure: Change in perceived workload on the Perceived Workload Scale
timeFrame: 4weeks, 8weeks after starting treatment
measure: Change in job self-efficacy on the Job Self-Efficacy Scale
timeFrame: 4weeks, 8weeks after starting treatment
measure: Change in sense of meaningfulness for job on the Sense of Meaningfulness for Job Scale
timeFrame: 4weeks, 8weeks after starting treatment
measure: Change in work orientation toward his or her job on the Work Orientation Scale
timeFrame: 4weeks, 8weeks after starting treatment
measure: Change in sense of psychological safety on the Perception of Psychological Safety Scale of Company Employees
timeFrame: 4weeks, 8weeks after starting treatment
measure: Change in firm performance on the Company weekly sales records
timeFrame: 4weeks, 8weeks after starting treatment
measure: Change in amsenteeism/leaves on the absenteeism/leave scales for employees with severe mental disabilities
timeFrame: 4weeks, 8weeks after starting treatment
measure: Change in stress regulation skill on the Emotional/Cognitive/Behavioral State Questionnaire
timeFrame: 4weeks, 8weeks after starting treatment
measure: Change in anxiety symptoms severity on the General Anxiety Disorder-7items scale
timeFrame: 4weeks, 8weeks after starting treatment
measure: Change in perceived stress level on the Perceived Stress Scale
timeFrame: 4weeks, 8weeks after starting treatment
measure: Change in social functioning on Social Adaptation Self Rating Scale
timeFrame: 4weeks, 8weeks after starting treatment
measure: Change in positive psychological capital on Korean version of Positive Psychological Capital Scale
timeFrame: 4weeks, 8weeks after starting treatment
measure: Change in Organizational Companionship on Organizational Culture Inventory
timeFrame: 4weeks, 8weeks after starting treatment
measure: Change in individual's social network on Lubben Social Network Scale-18
timeFrame: 4weeks, 8weeks after starting treatment
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou Medical University
Study officials:
affiliation: Ajou Medical Center
name: Chang Hyung Hong, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: