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

NCT03787407 | Completed

• 1 other identifier: B-1807/483-303
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress, Psychological

Keywords

resilience; emotional labor; mindfulness; neurofeedback

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Change from baseline Korean Emotional Labor Assessment Tool score

  Baseline and after 4, 8 weeks later

• Change from baseline Korean abbreviation of Occupational Stress Scale (KOSS) score

  Baseline and after 4, 8 weeks later

• Change from baseline Patient Health Questionnaire 9 (PHQ-9) score

  Baseline and after 4, 8 weeks later

• Change from baseline Brief resilience scale (BRS) score

  Baseline and after 4, 8 weeks later

• Change from baseline Athens Insomnia Scale (AIS) score

  Baseline and after 4, 8 weeks later

Study Arms (3)

Mindfulness training with neurofeedback

EXPERIMENTAL

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

Behavioral: stress management and meditation

Mindfulness training

ACTIVE COMPARATOR

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

Behavioral: stress management and meditation

Self-care

NO INTERVENTION

Interventions

stress management and meditation BEHAVIORAL

mindfulness training using mobile application

Mindfulness training; Mindfulness training with neurofeedback

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Ministry of Trade, Industry & Energy, Republic of Korea: collaborator

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13605, South Korea

Location

Related Publications (1)

• 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.

  PMID: 37788060 DERIVED

MeSH Terms

Conditions

Stress, Psychological

Interventions

Meditation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Jeong Hyun Kim, MD, Ph.D

  Seoul National Univerysity Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Healthy individuals recruited through advertisement

Study Record Dates

• First Submitted: December 23, 2018
• First Posted: December 26, 2018
• Study Start: August 7, 2018
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: January 11, 2019

Record last verified: 2018-12

Locations

KR (1)