DepressionNCT06295185
Digital Therapeutic Workplace Technology as a Employee Management Tool and Employee's Mental Health Care
A study testing application MARO in people with Depression and Mental Health Issue, run by Ajou University School of Medicine at 1 site in South Korea.
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'. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Mental Health Issue
- What is being tested?
- application MARO
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 165 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 May 2024to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HISBEANS store employees
- Age: 18 years old or older
- possessing a smartphone with internet connection
- subjects agree to participate in the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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'.
Read the 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.
- Conditions
- Depression, Mental Health Issue
- Being tested
- application MARO, Sham application
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
application MAROOther
It is a mental healthcare application aim to improve mental health.
Sham applicationOther
It is a sham application in order to control spill over bias.
| Study group | Role | What they receive |
|---|---|---|
| mental health treated with digital intervention app 'Maro' | Experimental | 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. Receives: Other: application MARO |
| Digital Sham App | Sham comparator | Control group will use Sham app for 8weeks. Receives: Other: Sham application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 4weeks, 8weeks after starting treatment
Secondary outcomes (15)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 4weeks, 8weeks after starting treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start20 May 2024
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang Hyung Hong, Ajou University School of Medicine
- Investigators
- Chang Hyung Hong, Ph.D, Principal investigator, Ajou Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06295185
- Sponsor's protocol ID
- AJOUIRB-IV-2024-097
- Status last verified
- Sep 2024
- First submitted
- 16 Feb 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06295185
- Acronym / sponsor ID
- AJOUIRB-IV-2024-097
- Conditions
- Depression, Mental Health Issue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- 20 May 2024 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 6 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mental health treated with digital intervention app 'Maro' | Experimental | Other: application MAROIntervention 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. |
| Digital Sham App | Sham comparator | Other: Sham applicationControl group will use Sham app for 8weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- HISBEANS store employees
- Age: 18 years old or older
- possessing a smartphone with internet connection
- subjects agree to participate in the study
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| application MAROIt is a mental healthcare application aim to improve mental health. | Other | mental health treated with digital intervention app 'Maro' |
| Sham applicationIt is a sham application in order to control spill over bias. | Other | Digital Sham App |
Primary outcome
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
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
15 secondary outcomes
Change in social capital on the Social Capital Scale
Time frame: 4weeks, 8weeks after starting treatment
Change in perceived workload on the Perceived Workload Scale
Time frame: 4weeks, 8weeks after starting treatment
Change in job self-efficacy on the Job Self-Efficacy Scale
Time frame: 4weeks, 8weeks after starting treatment
Change in sense of meaningfulness for job on the Sense of Meaningfulness for Job Scale
Time frame: 4weeks, 8weeks after starting treatment
Change in work orientation toward his or her job on the Work Orientation Scale
Time frame: 4weeks, 8weeks after starting treatment
Change in sense of psychological safety on the Perception of Psychological Safety Scale of Company Employees
Time frame: 4weeks, 8weeks after starting treatment
Change in firm performance on the Company weekly sales records
Time frame: 4weeks, 8weeks after starting treatment
Change in amsenteeism/leaves on the absenteeism/leave scales for employees with severe mental disabilities
Time frame: 4weeks, 8weeks after starting treatment
Change in stress regulation skill on the Emotional/Cognitive/Behavioral State Questionnaire
Time frame: 4weeks, 8weeks after starting treatment
Change in anxiety symptoms severity on the General Anxiety Disorder-7items scale
Time frame: 4weeks, 8weeks after starting treatment
Change in perceived stress level on the Perceived Stress Scale
Time frame: 4weeks, 8weeks after starting treatment
Change in social functioning on Social Adaptation Self Rating Scale
Time frame: 4weeks, 8weeks after starting treatment
Change in positive psychological capital on Korean version of Positive Psychological Capital Scale
Time frame: 4weeks, 8weeks after starting treatment
Change in Organizational Companionship on Organizational Culture Inventory
Time frame: 4weeks, 8weeks after starting treatment
Change in individual's social network on Lubben Social Network Scale-18
Time frame: 4weeks, 8weeks after starting treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chang Hyung Hong, Ph.D principal investigator
Ajou Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing application MARO in people with Depression and Mental Health Issue, run by Ajou University School of Medicine at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in network on the Standard Name Generator Approach scale (time frame: 4weeks, 8weeks after starting treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.