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

Stress, Psychological Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03787407
• Other study ID #: B-1807/483-303
• Status: Completed
• Phase: N/A
• Start date: August 7, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: December 2018
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stress, Psychological

Intervention

Behavioral:
• stress management and meditation
mindfulness training using mobile application

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Ministry of Trade, Industry & Energy, Republic of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and after 4, 8 weeks later
Secondary	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.	Baseline and after 4, 8 weeks later
Secondary	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.	Baseline and after 4, 8 weeks later
Secondary	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.	Baseline and after 4, 8 weeks later
Secondary	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)	Baseline and after 4, 8 weeks later
Secondary	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	Baseline and after 4, 8 weeks later
Secondary	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.	Baseline and after 4, 8 weeks later
Secondary	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	Baseline and after 4, 8 weeks later
Secondary	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.	Baseline and after 4, 8 weeks later
Secondary	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.	Baseline and after 4, 8 weeks later