An interventional study of stress management and meditation in Stress, Psychological, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-11.
Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Supportive care
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.
783 studies on the registry are indexed under Stress, Psychological; 128 are open to participants now.
This study's enrollment of 96 is above the median of 86 across 630 interventional studies indexed under Stress, Psychological.
Browse Stress, Psychological studies →Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
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Exclusion Criteria:
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 instruction and review of the application will be provided
Behavioral: stress management and meditation
mindfulness training using mobile application
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.
Time frame: Baseline and after 4, 8 weeks later
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.
Time frame: Baseline and after 4, 8 weeks later
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.
Time frame: Baseline and after 4, 8 weeks later
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.
Time frame: Baseline and after 4, 8 weeks later
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)
Time frame: Baseline and after 4, 8 weeks later
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
Time frame: Baseline and after 4, 8 weeks later
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.
Time frame: Baseline and after 4, 8 weeks later
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
Time frame: Baseline and after 4, 8 weeks later
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.
Time frame: Baseline and after 4, 8 weeks later
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.
Time frame: Baseline and after 4, 8 weeks later
This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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Seoul National University Hospital