<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03256682</url>
  </required_header>
  <id_info>
    <org_study_id>B-1707-408-305</org_study_id>
    <nct_id>NCT03256682</nct_id>
  </id_info>
  <brief_title>The Efficacy of Mobile Video Counseling for Employees With Emotional Labor</brief_title>
  <official_title>The Efficacy of a Mobile Video Counseling Targeted for Stress Reduction and Resilience Enhancement in Employees With Emotional Labor</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Trade, Industry &amp; Energy, Republic of Korea</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to verify the effectiveness of mobile video counseling for&#xD;
      workers. Subjects who can participate in the screening evaluation are assigned to one of&#xD;
      face-to-face counseling group, mobile counseling group, and self-treatment group. The mobile&#xD;
      counseling group and the face-to-face counseling group counseld with a total of 4 times, 50&#xD;
      minutes at a time, once a week, and the self-treatment group provides self-education by&#xD;
      providing the stress education kit.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After screening, Pre-evaluation is conducted on the subjects who agreed to participate in the&#xD;
      study. Pre-assessment includes questionnaires related to stress, emotional labor, resilience,&#xD;
      sleep, etc., and includes stress-related physiological measures using HRV, 2 lead EEG. After&#xD;
      the pre-evaluation, the test group will conduct a counseling program with a psychologist for&#xD;
      50 minutes at a time, once a week, for a total of 4 sessions (one month for a period). The&#xD;
      place should be placed in a quiet place where the subject thinks comfortably and is&#xD;
      designated as the same place to exclude the influence by the place, but the subject does not&#xD;
      have to visit the hospital. In the offline counseling group, four counseling sessions are&#xD;
      held with the psychologist off-line for a total of 4 counseling sessions, 50 minutes at a&#xD;
      time, once a week after the same pre-evaluation. As a self-care control, counseling is not&#xD;
      provided and self-learning materials are provided once a week.&#xD;
&#xD;
      Mobile counseling group and offline counseling group visit the hospital within one week after&#xD;
      termination and within 4 to 5 weeks after pre-evaluation in self-care control group. Also, to&#xD;
      see if the effect of mobile counseling is continued even after counseling is completed, visit&#xD;
      the counseling clinic one month after counseling is over and conduct the same test. The data&#xD;
      obtained from this study showed that the mobile counseling program measured the change in the&#xD;
      clinical scale and heart rate variability and EEG such as the stress and resilience of the&#xD;
      subjects, and the self-care group using the offline counseling group and stress data and&#xD;
      stress related psychological and physiological And compare the effects on the improvement of&#xD;
      the indicator.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2, 2017</start_date>
  <completion_date type="Actual">July 3, 2018</completion_date>
  <primary_completion_date type="Actual">July 3, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Healthy individuals recruited through advertisement</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline Perceived Stress Scale (PSS) score at 4, 8 weeks</measure>
    <time_frame>Baseline and after 4, 8 weeks later</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline Korean Emotional Labor Assessment Tool score at 4, 8 weeks</measure>
    <time_frame>Baseline and after 4, 8 weeks later</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline Korean abbreviation of Occupational Stress Scale (KOSS) score at 4, 8 weeks</measure>
    <time_frame>Baseline and after 4, 8 weeks later</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline Patient Health Questionnaire 9 (PHQ-9) score at 4, 8 weeks</measure>
    <time_frame>Baseline and after 4, 8 weeks later</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline Brief resilience scale (BRS) score at 4, 8 weeks</measure>
    <time_frame>Baseline and after 4, 8 weeks later</time_frame>
    <description>It is composed of 6 questions and is evaluated on the 5-point scale (1: not at all, 5: very much)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline Athens Insomnia Scale (AIS) score at 4, 8 weeks</measure>
    <time_frame>Baseline and after 4, 8 weeks later</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline Depression, Anxiety, Stress Scale (DASS) score at 4, 8 weeks</measure>
    <time_frame>Baseline and after 4, 8 weeks later</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline Connor-Davidson Resilience Scale (CD-RISC) score at 4, 8 weeks</measure>
    <time_frame>Baseline and after 4, 8 weeks later</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline Maslach Burnout Inventory-General Survey (MBI-GS) score at 4, 8 weeks</measure>
    <time_frame>Baseline and after 4, 8 weeks later</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline Heart rate variability (HRV) and Change from baseline Eletroencephalogram (EEG) score at 4, 8 weeks</measure>
    <time_frame>Baseline and after 4, 8 weeks later</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Counseling Satisfaction Scale</measure>
    <time_frame>After 4 weeks intervention</time_frame>
    <description>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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline Working Memory score at 4, 8 weeks</measure>
    <time_frame>Baseline and after 4, 8 weeks later</time_frame>
    <description>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.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">53</enrollment>
  <condition>Stress, Psychological</condition>
  <arm_group>
    <arm_group_label>Mobile Video Counseling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Utilize mobile imaging equipment, receive a total of 4 stress management consultations every 50 minutes at a time, once a week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Offline Counseling</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Receive a total of 4 stress management counseling, once a week for 50 minutes each session.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Selfcare</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Use stress management materials to manage yourself.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Stress management counseling</intervention_name>
    <description>stress management counseling based on CBT and relaxation</description>
    <arm_group_label>Mobile Video Counseling</arm_group_label>
    <arm_group_label>Offline Counseling</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Workers over the age of 19 and under 65&#xD;
&#xD;
          -  In the Perceived Stress Scale 14 points or more&#xD;
&#xD;
          -  If you are currently taking medication due to psychiatric illnesses such as&#xD;
             depression, anxiety disorder, insomnia, etc., if the stabilizer is expected to have no&#xD;
             change in drug dose during the clinical trial&#xD;
&#xD;
          -  If you understand the protocol and voluntarily agree to participate&#xD;
&#xD;
          -  If you have an Android phone&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age under 19, adult over 65&#xD;
&#xD;
          -  If you have dementia, intellectual disability, or other cognitive impairment&#xD;
&#xD;
          -  If you have convulsive disorder, stroke, or other neurological disorder&#xD;
&#xD;
          -  If you have psychosis such as schizophrenia or bipolar disorder or you have a history&#xD;
&#xD;
          -  If you have a disease that can affect the reliability of HRV test, such as heart&#xD;
             disease or lung disease.&#xD;
&#xD;
          -  Has received non-pharmacological psychiatric or counseling treatment within the&#xD;
             current or last 6 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeong Hyun Kim, MD, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National Univerysity Bundang Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam</city>
        <state>Gyeonggi-do</state>
        <zip>13605</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>August 18, 2017</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>April 4, 2019</last_update_submitted>
  <last_update_submitted_qc>April 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Resilience</keyword>
  <keyword>Mobile video counseling</keyword>
  <keyword>Emotiona labor</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress, Psychological</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03256682
org study id: B-1707-408-305
nct id: NCT03256682
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Healthy individuals recruited through advertisement
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change from baseline Perceived Stress Scale (PSS) score at 4, 8 weeks
time frame: Baseline and after 4, 8 weeks later
description: 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.
measure: Change from baseline Korean Emotional Labor Assessment Tool score at 4, 8 weeks
time frame: Baseline and after 4, 8 weeks later
description: 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.
measure: Change from baseline Korean abbreviation of Occupational Stress Scale (KOSS) score at 4, 8 weeks
time frame: Baseline and after 4, 8 weeks later
description: 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.
measure: Change from baseline Patient Health Questionnaire 9 (PHQ-9) score at 4, 8 weeks
time frame: Baseline and after 4, 8 weeks later
description: 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.
measure: Change from baseline Brief resilience scale (BRS) score at 4, 8 weeks
time frame: Baseline and after 4, 8 weeks later
description: It is composed of 6 questions and is evaluated on the 5-point scale (1: not at all, 5: very much)
measure: Change from baseline Athens Insomnia Scale (AIS) score at 4, 8 weeks
time frame: Baseline and after 4, 8 weeks later
description: 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
measure: Change from baseline Depression, Anxiety, Stress Scale (DASS) score at 4, 8 weeks
time frame: Baseline and after 4, 8 weeks later
description: 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
measure: Change from baseline Connor-Davidson Resilience Scale (CD-RISC) score at 4, 8 weeks
time frame: Baseline and after 4, 8 weeks later
description: 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
measure: Change from baseline Maslach Burnout Inventory-General Survey (MBI-GS) score at 4, 8 weeks
time frame: Baseline and after 4, 8 weeks later
description: 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.
measure: 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
description: 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.
measure: Counseling Satisfaction Scale
time frame: After 4 weeks intervention
description: 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.
measure: Change from baseline Working Memory score at 4, 8 weeks
time frame: Baseline and after 4, 8 weeks later
description: 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.
arm group label: Mobile Video Counseling
arm group type: Experimental
description: Utilize mobile imaging equipment, receive a total of 4 stress management consultations every 50 minutes at a time, once a week.
arm group label: Offline Counseling
arm group type: Active Comparator
description: Receive a total of 4 stress management counseling, once a week for 50 minutes each session.
arm group label: Selfcare
arm group type: No Intervention
description: Use stress management materials to manage yourself.
intervention type: Behavioral
intervention name: Stress management counseling
description: stress management counseling based on CBT and relaxation
arm group label: Mobile Video Counseling
arm group label: Offline Counseling
criteria: 
gender: All
minimum age: 19 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jeong Hyun Kim, MD, Ph.D
role: Principal Investigator
affiliation: Seoul National Univerysity Bundang Hospital
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Stress, Psychological
sharing ipd: Undecided