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Smartphone-based Stress Management Intervention for Employees

Primary Purpose

Stress, Psychological

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Stress guide
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stress, Psychological

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Any employee from three corporations (the Korea Gas Corporation (KOGAS), the Korea District Heating Corporation (KDHC), and the Korea Expressway Corporation (KEC)); any individual who visited the health promotion center for a health checkup at Seoul National University Bundang Hospital

Exclusion Criteria:

  • None

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

treatment arm

Arm Description

All individual is instructed to use the application we developed for 4 weeks

Outcomes

Primary Outcome Measures

Change from baseline Center for Epidemiologic Studies Depression Scale (CES-D) score at 4 weeks
Change from baseline Center for Epidemiologic Studies Depression Scale (CES-D) score at 4 weeks
Change from baseline Brief encounter psychosocial instrument (BEPSI-K) score at 4 weeks
Change from baseline Brief encounter psychosocial instrument (BEPSI-K) score at 4 weeks

Secondary Outcome Measures

Full Information

First Posted
July 12, 2017
Last Updated
July 17, 2017
Sponsor
Seoul National University Hospital
Collaborators
KT Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03222479
Brief Title
Smartphone-based Stress Management Intervention for Employees
Official Title
Development of Stress Guide for Employees: Smartphone-based Stress Management Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
January 1, 2013 (Actual)
Primary Completion Date
December 31, 2014 (Actual)
Study Completion Date
December 31, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital
Collaborators
KT Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Participants were able to use the application the investigators developed for four weeks. With the application, the participants were able to monitor their stress level and life style patterns. The participants were also provided personalized stress management techniques including psychoeducation and cognitive behavioral technique. In 2014, additional relaxation techniques-abdominal breathing, progressive muscular relaxation, and meditation-were incorporated. Participants' mental health status and life style patterns were evaluated at baseline and at 4 weeks. Pre- and post-intervention statuses were compared after adjusting for degrees of life stress factors. Brief encounter psychosocial instrument (BEPSI-K) score and Center for Epidemiologic Studies Depression Scale (CES-D) score were used as primary outcome measures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Healthy individuals recruited through advertisement
Masking
None (Open Label)
Allocation
N/A
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
treatment arm
Arm Type
Experimental
Arm Description
All individual is instructed to use the application we developed for 4 weeks
Intervention Type
Behavioral
Intervention Name(s)
Stress guide
Intervention Description
smartphone-based application that can evaluate stress level and teach how to manage their stress
Primary Outcome Measure Information:
Title
Change from baseline Center for Epidemiologic Studies Depression Scale (CES-D) score at 4 weeks
Description
Change from baseline Center for Epidemiologic Studies Depression Scale (CES-D) score at 4 weeks
Time Frame
Baseline and after the intervention for 4 weeks
Title
Change from baseline Brief encounter psychosocial instrument (BEPSI-K) score at 4 weeks
Description
Change from baseline Brief encounter psychosocial instrument (BEPSI-K) score at 4 weeks
Time Frame
Baseline and after the intervention for 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Any employee from three corporations (the Korea Gas Corporation (KOGAS), the Korea District Heating Corporation (KDHC), and the Korea Expressway Corporation (KEC)); any individual who visited the health promotion center for a health checkup at Seoul National University Bundang Hospital Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeong Hyun Kim, MD, Ph.D
Organizational Affiliation
Seoul National Univerysity Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi-do
ZIP/Postal Code
13605
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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Smartphone-based Stress Management Intervention for Employees

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