<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/NCT03787407</url>
  </required_header>
  <id_info>
    <org_study_id>B-1807/483-303</org_study_id>
    <nct_id>NCT03787407</nct_id>
  </id_info>
  <brief_title>The Effect of Neurofeedback-assisted Mindfulness Training in Employees With Emotional Labor</brief_title>
  <official_title>The Effect of Neurofeedback-assisted Mindfulness Training on Stress Reduction 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 effect of neurofeedback-assisted mindfulness&#xD;
      training for workers. Subjects who can participate in the screening are assigned to one&#xD;
      neurofeedback-assisted mindfulness training group, mindfulness only training group, and&#xD;
      self-treatment group. The neurofeedback-assisted mindfulness group and the mindfulness group&#xD;
      meet with psychologist and have education for the mindfulness training with or without&#xD;
      neurofeedback respectively, a total of 4 times, once a week. On the other hand, the&#xD;
      self-treatment group provides self-education by 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 neurofeedback-assisted mindfulness and mindfulness training group&#xD;
      will have education sessions with a psychologist for 30 minutes at a time, once a week, for a&#xD;
      total of 4 sessions (one month for a period). The education includes the instruction of the&#xD;
      application including mindfulness training, with or without neurofeedback, and the review for&#xD;
      the accomplishment of the training. Participants should follow the instruction and the&#xD;
      training schedule which is arranged in advance. On the other hand, for a self-care control,&#xD;
      the education sessions are not provided and self-learning materials are provided once a week.&#xD;
      The purpose of the study is to find the effectiveness of mindfulness training on reduction of&#xD;
      stress and severity of emotional labor. Especially, mindfulness training group with&#xD;
      neurofeedback might be expected to show the highest improvement in various clinical scales&#xD;
      and biomarkers including EEG and HRV.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 7, 2018</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 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>The full name: Perceived Stress Scale - 10 item form 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. Although the 14-item PSS tend to exhibit good reliability, four of the items tend to perform poorly when evaluated using exploratory factor analysis (Cohen et al., 1988). As a result, the PSS is commonly implemented using the 10-item form. The questions are rated on 5-point Likert scale; 0 (never), 1 (almost never), 2 (sometimes), 3 (fairly often), 4 (very often). Higher scores represent worse outcomes. The scores of each scale sum into the total score. Thus the total score ranges from 0 to 40.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline Korean Emotional Labor Assessment Tool score</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</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</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</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</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>Korean Mindful Attention Awareness Scale; K-MAAS</measure>
    <time_frame>Baseline and after 4, 8 weeks later</time_frame>
    <description>Modified from the Mindful Attention Awareness Scale, developed by Brown and Ryan (2003). 15-item scale designed to assess a core characteristic of dispositional mindfulness, namely, open or receptive awareness of and attention to what is taking place in the present.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroop test</measure>
    <time_frame>Baseline and after 4, 8 weeks later</time_frame>
    <description>assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart Rate Variability (HRV)</measure>
    <time_frame>Baseline and after 4, 8 weeks later</time_frame>
    <description>HRV is recorded with a device (neuroNicle FX2, Laxtha) which include EEG and HRV recording system. HRV is calculated from pulse rate signal recorded at earlobe.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantitative electroencephalography (QEEG)</measure>
    <time_frame>Baseline and after 4, 8 weeks later</time_frame>
    <description>EEG is recorded with a device (neuroNicle FX2, Laxtha) which include EEG and HRV recording system. EEG signal is acquired at the prefrontal area, two channels (FP1, FP2) on forehead.&#xD;
Power spectrum analysis of the EEG data will be performed using Fourier analysis. And absolute power, relative power, of each frequency band, symmetry are included.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">96</enrollment>
  <condition>Stress, Psychological</condition>
  <arm_group>
    <arm_group_label>Mindfulness training with neurofeedback</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>mindfulness training with neurofeedback using mobile application instruction and review of the application will be provided</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mindfulness training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>mindfulness training using mobile application instruction and review of the application will be provided</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Self-care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>stress management and meditation</intervention_name>
    <description>mindfulness training using mobile application</description>
    <arm_group_label>Mindfulness training</arm_group_label>
    <arm_group_label>Mindfulness training with neurofeedback</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., the dose must be stabilized for last 6&#xD;
             months, is expected to have no 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>December 2018</verification_date>
  <study_first_submitted>December 23, 2018</study_first_submitted>
  <study_first_submitted_qc>December 23, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>January 9, 2019</last_update_submitted>
  <last_update_submitted_qc>January 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>resilience</keyword>
  <keyword>emotional labor</keyword>
  <keyword>mindfulness</keyword>
  <keyword>neurofeedback</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress, Psychological</mesh_term>
  </condition_browse>
  <!-- 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/NCT03787407
org study id: B-1807/483-303
nct id: NCT03787407
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 effect of neurofeedback-assisted mindfulness
      training for workers. Subjects who can participate in the screening are assigned to one
      neurofeedback-assisted mindfulness training group, mindfulness only training group, and
      self-treatment group. The neurofeedback-assisted mindfulness group and the mindfulness group
      meet with psychologist and have education for the mindfulness training with or without
      neurofeedback respectively, a total of 4 times, once a week. On the other hand, 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 neurofeedback-assisted mindfulness and mindfulness training group
      will have education sessions with a psychologist for 30 minutes at a time, once a week, for a
      total of 4 sessions (one month for a period). The education includes the instruction of the
      application including mindfulness training, with or without neurofeedback, and the review for
      the accomplishment of the training. Participants should follow the instruction and the
      training schedule which is arranged in advance. On the other hand, for a self-care control,
      the education sessions are not provided and self-learning materials are provided once a week.
      The purpose of the study is to find the effectiveness of mindfulness training on reduction of
      stress and severity of emotional labor. Especially, mindfulness training group with
      neurofeedback might be expected to show the highest improvement in various clinical scales
      and biomarkers including EEG and HRV.
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: The full name: Perceived Stress Scale - 10 item form 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. Although the 14-item PSS tend to exhibit good reliability, four of the items tend to perform poorly when evaluated using exploratory factor analysis (Cohen et al., 1988). As a result, the PSS is commonly implemented using the 10-item form. The questions are rated on 5-point Likert scale; 0 (never), 1 (almost never), 2 (sometimes), 3 (fairly often), 4 (very often). Higher scores represent worse outcomes. The scores of each scale sum into the total score. Thus the total score ranges from 0 to 40.
measure: Change from baseline Korean Emotional Labor Assessment Tool score
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
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
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
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
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: Korean Mindful Attention Awareness Scale; K-MAAS
time frame: Baseline and after 4, 8 weeks later
description: Modified from the Mindful Attention Awareness Scale, developed by Brown and Ryan (2003). 15-item scale designed to assess a core characteristic of dispositional mindfulness, namely, open or receptive awareness of and attention to what is taking place in the present.
measure: Stroop test
time frame: Baseline and after 4, 8 weeks later
description: assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute
measure: Heart Rate Variability (HRV)
time frame: Baseline and after 4, 8 weeks later
description: HRV is recorded with a device (neuroNicle FX2, Laxtha) which include EEG and HRV recording system. HRV is calculated from pulse rate signal recorded at earlobe.
measure: Quantitative electroencephalography (QEEG)
time frame: Baseline and after 4, 8 weeks later
description: EEG is recorded with a device (neuroNicle FX2, Laxtha) which include EEG and HRV recording system. EEG signal is acquired at the prefrontal area, two channels (FP1, FP2) on forehead.
Power spectrum analysis of the EEG data will be performed using Fourier analysis. And absolute power, relative power, of each frequency band, symmetry are included.
arm group label: Mindfulness training with neurofeedback
arm group type: Experimental
description: mindfulness training with neurofeedback using mobile application instruction and review of the application will be provided
arm group label: Mindfulness training
arm group type: Active Comparator
description: mindfulness training using mobile application instruction and review of the application will be provided
arm group label: Self-care
arm group type: No Intervention
intervention type: Behavioral
intervention name: stress management and meditation
description: mindfulness training using mobile application
arm group label: Mindfulness training
arm group label: Mindfulness training with neurofeedback
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