Stress, PsychologicalNCT03787407
The Effect of Neurofeedback-assisted Mindfulness Training in Employees With Emotional Labor
A study testing stress management and meditation in people with Stress, Psychological, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological
- What is being tested?
- stress management and meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Aug 2018to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13605
About this study
Official title: The Effect of Neurofeedback-assisted Mindfulness Training on Stress Reduction in Employees With Emotional Labor
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.
Read the 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
- Being tested
- stress management and meditation
- Keywords
- resilience, emotional labor, mindfulness, neurofeedback
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stress management and meditationBehavioural
mindfulness training using mobile application
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness training with neurofeedback | Experimental | mindfulness training with neurofeedback using mobile application instruction and review of the application will be provided Receives: Behavioral: stress management and meditation |
| Mindfulness training | Active comparator | mindfulness training using mobile application instruction and review of the application will be provided Receives: Behavioral: stress management and meditation |
| Self-care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and after 4, 8 weeks later
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Baseline and after 4, 8 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2018
- Study start7 Aug 2018
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Healthy individuals recruited through advertisement
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Trade, Industry & Energy, Republic of Korea
- Responsible party
- Sponsor
- Investigators
- Jeong Hyun Kim, MD, Ph.D, Principal investigator, Seoul National Univerysity Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03787407
- Sponsor's protocol ID
- B-1807/483-303
- Status last verified
- Dec 2018
- First submitted
- 23 Dec 2018
- Last updated
- 11 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37788060
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Neurofeedback-assisted Mindfulness Training on Stress Reduction in Employees With Emotional Labor
- ClinicalTrials.gov ID
- NCT03787407
- Acronym / sponsor ID
- B-1807/483-303
- Conditions
- Stress, Psychological
- Keywords
- resilience, emotional labor, mindfulness, neurofeedback
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Trade, Industry & Energy, Republic of Korea
- Study start
- 7 Aug 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 26 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Healthy individuals recruited through advertisement
| Arm | Type | Receives |
|---|---|---|
| Mindfulness training with neurofeedback | Experimental | Behavioral: stress management and meditationmindfulness training with neurofeedback using mobile application instruction and review of the application will be provided |
| Mindfulness training | Active comparator | Behavioral: stress management and meditationmindfulness training using mobile application instruction and review of the application will be provided |
| Self-care | No intervention | – |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stress management and meditationmindfulness training using mobile application | Behavioural | Mindfulness training, Mindfulness training with neurofeedback |
Primary outcome
Change from baseline Perceived Stress Scale (PSS) score at 4, 8 weeks
Time frame: Baseline and after 4, 8 weeks later
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.
9 secondary outcomes
Change from baseline Korean Emotional Labor Assessment Tool score
Time frame: Baseline and after 4, 8 weeks later
Change from baseline Korean abbreviation of Occupational Stress Scale (KOSS) score
Time frame: Baseline and after 4, 8 weeks later
Change from baseline Patient Health Questionnaire 9 (PHQ-9) score
Time frame: Baseline and after 4, 8 weeks later
Change from baseline Brief resilience scale (BRS) score
Time frame: Baseline and after 4, 8 weeks later
Change from baseline Athens Insomnia Scale (AIS) score
Time frame: Baseline and after 4, 8 weeks later
Korean Mindful Attention Awareness Scale; K-MAAS
Time frame: Baseline and after 4, 8 weeks later
Stroop test
Time frame: Baseline and after 4, 8 weeks later
Heart Rate Variability (HRV)
Time frame: Baseline and after 4, 8 weeks later
Quantitative electroencephalography (QEEG)
Time frame: Baseline and after 4, 8 weeks later
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2019.
- Derived from this study: PubMed 37788060Min 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeong Hyun Kim, MD, Ph.D principal investigator
Seoul National Univerysity Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stress management and meditation in people with Stress, Psychological, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Perceived Stress Scale (PSS) score at 4, 8 weeks (time frame: Baseline and after 4, 8 weeks later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03787407, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2019.