The Efficacy of Mobile Video Counseling for Employees With Emotional Labor

April 4, 2019 updated by: Seoul National University Hospital

The Efficacy of a Mobile Video Counseling Targeted for Stress Reduction and Resilience Enhancement in Employees With Emotional Labor

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

After screening, Pre-evaluation is conducted on the subjects who agreed to participate in the study. Pre-assessment includes questionnaires related to stress, emotional labor, resilience, sleep, etc., and includes stress-related physiological measures using HRV, 2 lead EEG. After the pre-evaluation, the test group will conduct a counseling program with a psychologist for 50 minutes at a time, once a week, for a total of 4 sessions (one month for a period). The place should be placed in a quiet place where the subject thinks comfortably and is designated as the same place to exclude the influence by the place, but the subject does not have to visit the hospital. In the offline counseling group, four counseling sessions are held with the psychologist off-line for a total of 4 counseling sessions, 50 minutes at a time, once a week after the same pre-evaluation. As a self-care control, counseling is not provided and self-learning materials are provided once a week.

Mobile counseling group and offline counseling group visit the hospital within one week after termination and within 4 to 5 weeks after pre-evaluation in self-care control group. Also, to see if the effect of mobile counseling is continued even after counseling is completed, visit the counseling clinic one month after counseling is over and conduct the same test. The data obtained from this study showed that the mobile counseling program measured the change in the clinical scale and heart rate variability and EEG such as the stress and resilience of the subjects, and the self-care group using the offline counseling group and stress data and stress related psychological and physiological And compare the effects on the improvement of the indicator.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
53

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Korea, Republic of
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Mobile Video Counseling
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
stress management counseling based on CBT and relaxation
Active Comparator: Offline Counseling
Receive a total of 4 stress management counseling, once a week for 50 minutes each session.
Behavioral: Stress management counseling
stress management counseling based on CBT and relaxation
No Intervention: Selfcare
Use stress management materials to manage yourself.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline Perceived Stress Scale (PSS) score at 4, 8 weeks
Time Frame: Baseline and after 4, 8 weeks later
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline Korean Emotional Labor Assessment Tool score at 4, 8 weeks
Time Frame: Baseline and after 4, 8 weeks later
The total of 26 items were Emotional expression and control 5 items, organizational monitoring and management system 4 items, forced customer response 4 items, emotional damage 6 items, organizational protection system 7 items, and organizational protection system is reverse coding and summed up. 4 point Likert scale (1 = not at all, 5 = very much), and the possible total score ranges from 26 to 130 points. The higher the score, the more emotional labor means.
Baseline and after 4, 8 weeks later
Change from baseline Korean abbreviation of Occupational Stress Scale (KOSS) score at 4, 8 weeks
Time Frame: Baseline and after 4, 8 weeks later
total of 24 items were used, and each item was not at all (from 1 point) to very much (5 points). The higher the score, the more the job stress means. Job demand, Insufficient job control, job insecurity, interpersonal conflict, Organizational system, Lack of reward and Occupational climate.
Baseline and after 4, 8 weeks later
Change from baseline Patient Health Questionnaire 9 (PHQ-9) score at 4, 8 weeks
Time Frame: Baseline and after 4, 8 weeks later
The total score is 0 to 27, and the higher the total score, the more severe the depressive symptoms. Cutpoints of 5, 10, 15 and 20 represent the thresholds for mild, moderate, moderate severe, and severe depression, respectively.
Baseline and after 4, 8 weeks later
Change from baseline Brief resilience scale (BRS) score at 4, 8 weeks
Time Frame: Baseline and after 4, 8 weeks later
It is composed of 6 questions and is evaluated on the 5-point scale (1: not at all, 5: very much)
Baseline and after 4, 8 weeks later
Change from baseline Athens Insomnia Scale (AIS) score at 4, 8 weeks
Time Frame: Baseline and after 4, 8 weeks later
total score of 6 points was used as a breakpoint, this Using the quality index of Pittsburgh Sleep, which is widely used to evaluate the quality of sleep
Baseline and after 4, 8 weeks later
Change from baseline Depression, Anxiety, Stress Scale (DASS) score at 4, 8 weeks
Time Frame: Baseline and after 4, 8 weeks later
A total of 21 questions, depression, anxiety, and stress were assessed on a 4-point scale (0: not at all, 3: very or almost always). In this study, only 7 items relating to anxiety were extracted. The lowest score is from 0 to the maximum score of 21, and the higher the score, the more severe anxiety. Anxiety scores above 8 indicate significant anxiety symptoms
Baseline and after 4, 8 weeks later
Change from baseline Connor-Davidson Resilience Scale (CD-RISC) score at 4, 8 weeks
Time Frame: Baseline and after 4, 8 weeks later
A total of 25 items were assessed as a 5-point Likert scale (0: not at all, 4: very much). A score of 0-100 means higher resilience
Baseline and after 4, 8 weeks later
Change from baseline Maslach Burnout Inventory-General Survey (MBI-GS) score at 4, 8 weeks
Time Frame: Baseline and after 4, 8 weeks later
Evaluate on a total of 16 questions on a 7 point scale (1 point = not at all, 7 points = very much). The higher the total score, the greater the degree of job exhaustion.
Baseline and after 4, 8 weeks later
Change from baseline Heart rate variability (HRV) and Change from baseline Eletroencephalogram (EEG) score at 4, 8 weeks
Time Frame: Baseline and after 4, 8 weeks later
The instrument measures the EEG from the headset forehead sensor (EEG measurement of the prefrontal lobe, 2 channel EEG) and measures the pulse at the earlobe (measure the pulse rate in the earlobe vessel using a light sensor). The results of EEG and heart rate variability were calculated by measuring for 5 minutes.
Baseline and after 4, 8 weeks later

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Counseling Satisfaction Scale
Time Frame: After 4 weeks intervention
Evaluate within 7 days of closing psychological counseling. Twelve questions to evaluate the quality of psychological counseling, content, psychological counselor 's attitude, procedures, and six questions to measure accessibility and a written description question for the proposal. The mobile group further includes questions such as system speed, image quality, sound and so on. Evaluating from not at all (1 point) very much (5 points), which means that the higher the score is, the higher the degree of satisfaction is.
After 4 weeks intervention
Change from baseline Working Memory score at 4, 8 weeks
Time Frame: Baseline and after 4, 8 weeks later
Measure short-term memory, work function known to be sensitive to stress. It consists of forward, backward, sequencing, scored 0 - 14 points, and means that the higher the score, the better the function.
Baseline and after 4, 8 weeks later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seoul National University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ministry of Trade, Industry & Energy, Republic of Korea

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jeong Hyun Kim, MD, Ph.D, Seoul National Univerysity Bundang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 2, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 3, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 3, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 18, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 22, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 5, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B-1707-408-305

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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