NCT06295185

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'.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 6, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

May 20, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

2 months

First QC Date

February 16, 2024

Last Update Submit

September 9, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (15)

  • Change in social capital on the Social Capital Scale

    4weeks, 8weeks after starting treatment

  • Change in perceived workload on the Perceived Workload Scale

    4weeks, 8weeks after starting treatment

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

    4weeks, 8weeks after starting treatment

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

    4weeks, 8weeks after starting treatment

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

    4weeks, 8weeks after starting treatment

  • +10 more secondary outcomes

Study Arms (2)

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.

Other: application MARO

Digital Sham App

SHAM COMPARATOR

Control group will use Sham app for 8weeks.

Other: Sham application

Interventions

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

mental health treated with digital intervention app 'Maro'

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

Digital Sham App

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ajou Medical University

Suwon, 16499, South Korea

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Chang Hyung Hong, Ph.D

    Ajou Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 16, 2024

First Posted

March 6, 2024

Study Start

May 20, 2024

Primary Completion

July 31, 2024

Study Completion

July 31, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations