NCT03256682

Brief Summary

The purpose of this study is to verify the effectiveness of mobile video counseling for workers. Subjects who can participate in the screening evaluation are assigned to one of face-to-face counseling group, mobile counseling group, and self-treatment group. The mobile counseling group and the face-to-face counseling group counseld with a total of 4 times, 50 minutes at a time, once a week, and the self-treatment group provides self-education by providing the stress education kit.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2017

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

August 2, 2017

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

August 18, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 22, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 3, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 3, 2018

Completed
Last Updated

April 5, 2019

Status Verified

July 1, 2017

Enrollment Period

11 months

First QC Date

August 18, 2017

Last Update Submit

April 4, 2019

Conditions

Keywords

ResilienceMobile video counselingEmotiona labor

Outcome Measures

Primary Outcomes (1)

  • Change from baseline Perceived Stress Scale (PSS) score at 4, 8 weeks

    14-item scale developed by Cohen et al. (1983) that emphasizes subjective perception of stress. Measures the degree of perceived unforeseeable, uncontrollable, and overwhelming experience of stress in the past month.

    Baseline and after 4, 8 weeks later

Secondary Outcomes (9)

  • Change from baseline Korean Emotional Labor Assessment Tool score at 4, 8 weeks

    Baseline and after 4, 8 weeks later

  • Change from baseline Korean abbreviation of Occupational Stress Scale (KOSS) score at 4, 8 weeks

    Baseline and after 4, 8 weeks later

  • Change from baseline Patient Health Questionnaire 9 (PHQ-9) score at 4, 8 weeks

    Baseline and after 4, 8 weeks later

  • Change from baseline Brief resilience scale (BRS) score at 4, 8 weeks

    Baseline and after 4, 8 weeks later

  • Change from baseline Athens Insomnia Scale (AIS) score at 4, 8 weeks

    Baseline and after 4, 8 weeks later

  • +4 more secondary outcomes

Other Outcomes (2)

  • Counseling Satisfaction Scale

    After 4 weeks intervention

  • Change from baseline Working Memory score at 4, 8 weeks

    Baseline and after 4, 8 weeks later

Study Arms (3)

Mobile Video Counseling

EXPERIMENTAL

Utilize mobile imaging equipment, receive a total of 4 stress management consultations every 50 minutes at a time, once a week.

Behavioral: Stress management counseling

Offline Counseling

ACTIVE COMPARATOR

Receive a total of 4 stress management counseling, once a week for 50 minutes each session.

Behavioral: Stress management counseling

Selfcare

NO INTERVENTION

Use stress management materials to manage yourself.

Interventions

stress management counseling based on CBT and relaxation

Mobile Video CounselingOffline Counseling

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Workers over the age of 19 and under 65
  • In the Perceived Stress Scale 14 points or more
  • If you are currently taking medication due to psychiatric illnesses such as depression, anxiety disorder, insomnia, etc., if the stabilizer is expected to have no change in drug dose during the clinical trial
  • If you understand the protocol and voluntarily agree to participate
  • If you have an Android phone

You may not qualify if:

  • Age under 19, adult over 65
  • If you have dementia, intellectual disability, or other cognitive impairment
  • If you have convulsive disorder, stroke, or other neurological disorder
  • If you have psychosis such as schizophrenia or bipolar disorder or you have a history
  • If you have a disease that can affect the reliability of HRV test, such as heart disease or lung disease.
  • Has received non-pharmacological psychiatric or counseling treatment within the current or last 6 months.

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

Related Publications (2)

  • Kunzler AM, Helmreich I, Chmitorz A, Konig J, Binder H, Wessa M, Lieb K. Psychological interventions to foster resilience in healthcare professionals. Cochrane Database Syst Rev. 2020 Jul 5;7(7):CD012527. doi: 10.1002/14651858.CD012527.pub2.

  • Kim JI, Yun JY, Park H, Park SY, Ahn Y, Lee H, Kim TK, Yoon S, Lee YJ, Oh S, Denninger JW, Kim BN, Kim JH. A Mobile Videoconference-Based Intervention on Stress Reduction and Resilience Enhancement in Employees: Randomized Controlled Trial. J Med Internet Res. 2018 Oct 22;20(10):e10760. doi: 10.2196/10760.

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
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Healthy individuals recruited through advertisement
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2017

First Posted

August 22, 2017

Study Start

August 2, 2017

Primary Completion

July 3, 2018

Study Completion

July 3, 2018

Last Updated

April 5, 2019

Record last verified: 2017-07

Locations