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The Effect of Neurofeedback-assisted Mindfulness Training in Employees With Emotional Labor

Primary Purpose

Stress, Psychological

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
stress management and meditation
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stress, Psychological focused on measuring resilience, emotional labor, mindfulness, neurofeedback

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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., the dose must be stabilized for last 6 months, 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.

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Mindfulness training with neurofeedback

Mindfulness training

Self-care

Arm Description

mindfulness training with neurofeedback using mobile application instruction and review of the application will be provided

mindfulness training using mobile application instruction and review of the application will be provided

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from baseline Korean Emotional Labor Assessment Tool score
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.
Change from baseline Korean abbreviation of Occupational Stress Scale (KOSS) score
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.
Change from baseline Patient Health Questionnaire 9 (PHQ-9) score
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.
Change from baseline Brief resilience scale (BRS) score
It is composed of 6 questions and is evaluated on the 5-point scale (1: not at all, 5: very much)
Change from baseline Athens Insomnia Scale (AIS) score
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
Korean Mindful Attention Awareness Scale; K-MAAS
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.
Stroop test
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
Heart Rate Variability (HRV)
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.
Quantitative electroencephalography (QEEG)
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.

Full Information

First Posted
December 23, 2018
Last Updated
January 9, 2019
Sponsor
Seoul National University Hospital
Collaborators
Ministry of Trade, Industry & Energy, Republic of Korea
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1. Study Identification

Unique Protocol Identification Number
NCT03787407
Brief Title
The Effect of Neurofeedback-assisted Mindfulness Training in Employees With Emotional Labor
Official Title
The Effect of Neurofeedback-assisted Mindfulness Training on Stress Reduction in Employees With Emotional Labor
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
August 7, 2018 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital
Collaborators
Ministry of Trade, Industry & Energy, Republic of Korea

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological
Keywords
resilience, emotional labor, mindfulness, neurofeedback

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Healthy individuals recruited through advertisement
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness training with neurofeedback
Arm Type
Experimental
Arm Description
mindfulness training with neurofeedback using mobile application instruction and review of the application will be provided
Arm Title
Mindfulness training
Arm Type
Active Comparator
Arm Description
mindfulness training using mobile application instruction and review of the application will be provided
Arm Title
Self-care
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
stress management and meditation
Intervention Description
mindfulness training using mobile application
Primary Outcome Measure Information:
Title
Change from baseline Perceived Stress Scale (PSS) score at 4, 8 weeks
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.
Time Frame
Baseline and after 4, 8 weeks later
Secondary Outcome Measure Information:
Title
Change from baseline Korean Emotional Labor Assessment Tool score
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.
Time Frame
Baseline and after 4, 8 weeks later
Title
Change from baseline Korean abbreviation of Occupational Stress Scale (KOSS) score
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.
Time Frame
Baseline and after 4, 8 weeks later
Title
Change from baseline Patient Health Questionnaire 9 (PHQ-9) score
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.
Time Frame
Baseline and after 4, 8 weeks later
Title
Change from baseline Brief resilience scale (BRS) score
Description
It is composed of 6 questions and is evaluated on the 5-point scale (1: not at all, 5: very much)
Time Frame
Baseline and after 4, 8 weeks later
Title
Change from baseline Athens Insomnia Scale (AIS) score
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
Time Frame
Baseline and after 4, 8 weeks later
Title
Korean Mindful Attention Awareness Scale; K-MAAS
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.
Time Frame
Baseline and after 4, 8 weeks later
Title
Stroop test
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
Time Frame
Baseline and after 4, 8 weeks later
Title
Heart Rate Variability (HRV)
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.
Time Frame
Baseline and after 4, 8 weeks later
Title
Quantitative electroencephalography (QEEG)
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.
Time Frame
Baseline and after 4, 8 weeks later

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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., the dose must be stabilized for last 6 months, 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeong Hyun Kim, MD, Ph.D
Organizational Affiliation
Seoul National Univerysity Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi-do
ZIP/Postal Code
13605
Country
Korea, Republic of

12. IPD Sharing Statement

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The Effect of Neurofeedback-assisted Mindfulness Training in Employees With Emotional Labor

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