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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06295185
Other study ID # AJOUIRB-IV-2024-097
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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