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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03222479
Other study ID # B-1206/158-112
Secondary ID
Status Completed
Phase N/A
First received July 12, 2017
Last updated July 17, 2017
Start date January 1, 2013
Est. completion date December 31, 2014

Study information

Verified date July 2017
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 68
Est. completion date December 31, 2014
Est. primary completion date December 31, 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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:

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Stress guide
smartphone-based application that can evaluate stress level and teach how to manage their stress

Locations

Country Name City State
Korea, Republic of Seoul National University Bundang Hospital Seongnam Gyeonggi-do

Sponsors (2)

Lead Sponsor Collaborator
Seoul National University Hospital KT Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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