Clinical trial NCT03787407: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Psychological
Keywords: resilience
emotional labor
mindfulness
neurofeedback
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Trade, Industry & Energy, Republic of Korea
First posted: 2018-12-26
Enrollment: 96
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Healthy individuals recruited through advertisement
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Change from baseline Perceived Stress Scale (PSS) score at 4, 8 weeks
timeFrame: Baseline and after 4, 8 weeks later
Secondary outcomes:
measure: Change from baseline Korean Emotional Labor Assessment Tool score
timeFrame: Baseline and after 4, 8 weeks later
measure: Change from baseline Korean abbreviation of Occupational Stress Scale (KOSS) score
timeFrame: Baseline and after 4, 8 weeks later
measure: Change from baseline Patient Health Questionnaire 9 (PHQ-9) score
timeFrame: Baseline and after 4, 8 weeks later
measure: Change from baseline Brief resilience scale (BRS) score
timeFrame: Baseline and after 4, 8 weeks later
measure: Change from baseline Athens Insomnia Scale (AIS) score
timeFrame: Baseline and after 4, 8 weeks later
measure: Korean Mindful Attention Awareness Scale; K-MAAS
timeFrame: Baseline and after 4, 8 weeks later
measure: Stroop test
timeFrame: Baseline and after 4, 8 weeks later
measure: Heart Rate Variability (HRV)
timeFrame: Baseline and after 4, 8 weeks later
measure: Quantitative electroencephalography (QEEG)
timeFrame: Baseline and after 4, 8 weeks later
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National Univerysity Bundang Hospital
name: Jeong Hyun Kim, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: