NCT03222479

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable

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

Study Start

First participant enrolled

January 1, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2014

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

July 12, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 19, 2017

Completed
Last Updated

July 19, 2017

Status Verified

July 1, 2017

Enrollment Period

2 years

First QC Date

July 12, 2017

Last Update Submit

July 17, 2017

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

    Baseline and after the intervention for 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

    Baseline and after the intervention for 4 weeks

Study Arms (1)

treatment arm

EXPERIMENTAL

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

Behavioral: Stress guide

Interventions

Stress guideBEHAVIORAL

smartphone-based application that can evaluate stress level and teach how to manage their stress

treatment arm

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13605, South Korea

Location

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Jeong Hyun Kim, MD, Ph.D

    Seoul National Univerysity Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Healthy individuals recruited through advertisement
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2017

First Posted

July 19, 2017

Study Start

January 1, 2013

Primary Completion

December 31, 2014

Study Completion

December 31, 2014

Last Updated

July 19, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations