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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03787407
Recruitment Status : Completed
First Posted : December 25, 2018
Last Update Posted : January 11, 2019
Sponsor:
Collaborator:
Ministry of Trade, Industry & Energy, Republic of Korea
Information provided by (Responsible Party):
Seoul National University Hospital

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.

Condition or disease Intervention/treatment Phase
Stress, Psychological Behavioral: stress management and meditation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Healthy individuals recruited through advertisement
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Effect of Neurofeedback-assisted Mindfulness Training on Stress Reduction in Employees With Emotional Labor
Actual Study Start Date : August 7, 2018
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stress

Arm Intervention/treatment
Experimental: Mindfulness training with neurofeedback
mindfulness training with neurofeedback using mobile application instruction and review of the application will be provided
Behavioral: stress management and meditation
mindfulness training using mobile application

Active Comparator: Mindfulness training
mindfulness training using mobile application instruction and review of the application will be provided
Behavioral: stress management and meditation
mindfulness training using mobile application

No Intervention: Self-care



Primary Outcome Measures :
  1. Change from baseline Perceived Stress Scale (PSS) score at 4, 8 weeks [ Time Frame: Baseline and after 4, 8 weeks later ]
    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 :
  1. Change from baseline Korean Emotional Labor Assessment Tool score [ 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.

  2. Change from baseline Korean abbreviation of Occupational Stress Scale (KOSS) score [ 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.

  3. Change from baseline Patient Health Questionnaire 9 (PHQ-9) score [ 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.

  4. Change from baseline Brief resilience scale (BRS) score [ 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)

  5. Change from baseline Athens Insomnia Scale (AIS) score [ 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

  6. Korean Mindful Attention Awareness Scale; K-MAAS [ Time Frame: Baseline and after 4, 8 weeks later ]
    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.

  7. Stroop test [ Time Frame: Baseline and after 4, 8 weeks later ]
    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

  8. Heart Rate Variability (HRV) [ Time Frame: Baseline and after 4, 8 weeks later ]
    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.

  9. Quantitative electroencephalography (QEEG) [ Time Frame: Baseline and after 4, 8 weeks later ]

    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.




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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03787407


Locations
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Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Gyeonggi-do, Korea, Republic of, 13605
Sponsors and Collaborators
Seoul National University Hospital
Ministry of Trade, Industry & Energy, Republic of Korea
Investigators
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Principal Investigator: Jeong Hyun Kim, MD, Ph.D Seoul National Univerysity Bundang Hospital

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Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03787407     History of Changes
Other Study ID Numbers: B-1807/483-303
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Seoul National University Hospital:
resilience
emotional labor
mindfulness
neurofeedback

Additional relevant MeSH terms:
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Stress, Psychological
Behavioral Symptoms