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

NCT ID: NCT03787407

Last Updated: 2019-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-07
• Study Completion Date: 2018-12-31

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.

Conditions

Stress, Psychological

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Mindfulness training with neurofeedback

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

Group Type: EXPERIMENTAL

stress management and meditation

Intervention Type: BEHAVIORAL

mindfulness training using mobile application

Mindfulness training

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

Group Type: ACTIVE_COMPARATOR

stress management and meditation

Intervention Type: BEHAVIORAL

mindfulness training using mobile application

Self-care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

stress management and meditation

mindfulness training using mobile application

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ministry of Trade, Industry & Energy, Republic of Korea

OTHER_GOV

Sponsor Role: collaborator

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeong Hyun Kim, MD, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Seoul National Univerysity Bundang Hospital

Locations

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Countries

South Korea

References

Min B, Park H, Kim JI, Lee S, Back S, Lee E, Oh S, Yun JY, Kim BN, Kim Y, Hwang J, Lee S, Kim JH. The Effectiveness of a Neurofeedback-Assisted Mindfulness Training Program Using a Mobile App on Stress Reduction in Employees: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2023 Oct 3;11:e42851. doi: 10.2196/42851.

Reference Type: DERIVED

PMID: 37788060 (View on PubMed)

Other Identifiers

B-1807/483-303

Identifier Type: -

Identifier Source: org_study_id