- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03222479
Smartphone-based Stress Management Intervention for Employees
July 17, 2017 updated by: Seoul National University Hospital
Development of Stress Guide for Employees: Smartphone-based Stress Management Intervention
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
68
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gyeonggi-do
-
Seongnam, Gyeonggi-do, Korea, Republic of, 13605
- Seoul National University Bundang Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: treatment arm
All individual is instructed to use the application we developed for 4 weeks
|
smartphone-based application that can evaluate stress level and teach how to manage their stress
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Change from baseline Center for Epidemiologic Studies Depression Scale (CES-D) score at 4 weeks
|
Baseline and after the intervention for 4 weeks
|
|
Change from baseline Brief encounter psychosocial instrument (BEPSI-K) score at 4 weeks
Time Frame: Baseline and after the intervention for 4 weeks
|
Change from baseline Brief encounter psychosocial instrument (BEPSI-K) score at 4 weeks
|
Baseline and after the intervention for 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Jeong Hyun Kim, MD, Ph.D, Seoul National Univerysity Bundang Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2013
Primary Completion (Actual)
December 31, 2014
Study Completion (Actual)
December 31, 2014
Study Registration Dates
First Submitted
July 12, 2017
First Submitted That Met QC Criteria
July 17, 2017
First Posted (Actual)
July 19, 2017
Study Record Updates
Last Update Posted (Actual)
July 19, 2017
Last Update Submitted That Met QC Criteria
July 17, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B-1206/158-112
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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