Stress, PsychologicalNCT03256682
The Efficacy of Mobile Video Counseling for Employees With Emotional Labor
A study testing Stress management counseling 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 effectiveness of mobile video counseling for workers. Subjects who can participate in the screening evaluation are assigned to one of face-to-face counseling group, mobile counseling 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 counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Aug 2017to 3 Jul 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., if the stabilizer 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 Efficacy of a Mobile Video Counseling Targeted for Stress Reduction and Resilience Enhancement in Employees With Emotional Labor
The purpose of this study is to verify the effectiveness of mobile video counseling for workers. Subjects who can participate in the screening evaluation are assigned to one of face-to-face counseling group, mobile counseling group, and self-treatment group. The mobile counseling group and the face-to-face counseling group counseld with a total of 4 times, 50 minutes at a time, once a week, and 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 test group will conduct a counseling program with a psychologist for 50 minutes at a time, once a week, for a total of 4 sessions (one month for a period). The place should be placed in a quiet place where the subject thinks comfortably and is designated as the same place to exclude the influence by the place, but the subject does not have to visit the hospital. In the offline counseling group, four counseling sessions are held with the psychologist off-line for a total of 4 counseling sessions, 50 minutes at a time, once a week after the same pre-evaluation. As a self-care control, counseling is not provided and self-learning materials are provided once a week.
Mobile counseling group and offline counseling group visit the hospital within one week after termination and within 4 to 5 weeks after pre-evaluation in self-care control group. Also, to see if the effect of mobile counseling is continued even after counseling is completed, visit the counseling clinic one month after counseling is over and conduct the same test. The data obtained from this study showed that the mobile counseling program measured the change in the clinical scale and heart rate variability and EEG such as the stress and resilience of the subjects, and the self-care group using the offline counseling group and stress data and stress related psychological and physiological And compare the effects on the improvement of the indicator.
- Conditions
- Stress, Psychological
- Being tested
- Stress management counseling
- Keywords
- Resilience, Mobile video counseling, Emotiona labor
- 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 counselingBehavioural
stress management counseling based on CBT and relaxation
| Study group | Role | What they receive |
|---|---|---|
| Mobile Video Counseling | Experimental | Utilize mobile imaging equipment, receive a total of 4 stress management consultations every 50 minutes at a time, once a week. Receives: Behavioral: Stress management counseling |
| Offline Counseling | Active comparator | Receive a total of 4 stress management counseling, once a week for 50 minutes each session. Receives: Behavioral: Stress management counseling |
| Selfcare | No intervention | Use stress management materials to manage yourself. |
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
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.
Measured: Baseline and after 4, 8 weeks later
Secondary outcomes (9)
Change from baseline Korean Emotional Labor Assessment Tool score at 4, 8 weeks
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 at 4, 8 weeks
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 at 4, 8 weeks
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 at 4, 8 weeks
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 at 4, 8 weeks
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
Change from baseline Depression, Anxiety, Stress Scale (DASS) score at 4, 8 weeks
A total of 21 questions, depression, anxiety, and stress were assessed on a 4-point scale (0: not at all, 3: very or almost always). In this study, only 7 items relating to anxiety were extracted. The lowest score is from 0 to the maximum score of 21, and the higher the score, the more severe anxiety. Anxiety scores above 8 indicate significant anxiety symptoms
Measured: Baseline and after 4, 8 weeks later
Change from baseline Connor-Davidson Resilience Scale (CD-RISC) score at 4, 8 weeks
A total of 25 items were assessed as a 5-point Likert scale (0: not at all, 4: very much). A score of 0-100 means higher resilience
Measured: Baseline and after 4, 8 weeks later
Change from baseline Maslach Burnout Inventory-General Survey (MBI-GS) score at 4, 8 weeks
Evaluate on a total of 16 questions on a 7 point scale (1 point = not at all, 7 points = very much). The higher the total score, the greater the degree of job exhaustion.
Measured: Baseline and after 4, 8 weeks later
Change from baseline Heart rate variability (HRV) and Change from baseline Eletroencephalogram (EEG) score at 4, 8 weeks
The instrument measures the EEG from the headset forehead sensor (EEG measurement of the prefrontal lobe, 2 channel EEG) and measures the pulse at the earlobe (measure the pulse rate in the earlobe vessel using a light sensor). The results of EEG and heart rate variability were calculated by measuring for 5 minutes.
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 posted22 Aug 2017
- Study start2 Aug 2017
- Primary completion3 Jul 2018
- Study completion3 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 53 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
- NCT03256682
- Sponsor's protocol ID
- B-1707-408-305
- Status last verified
- Jul 2017
- First submitted
- 18 Aug 2017
- Last updated
- 5 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kunzler AM, Helmreich I, Chmitorz A, Konig J, Binder H, Wessa M, Lieb K. Psychological interventions to foster resilience in healthcare professionals. Cochrane Database Syst Rev. 2020 Jul 5;7(7):CD012527. doi: 10.1002/14651858.CD012527.pub2.
PubMed 32627860Kim JI, Yun JY, Park H, Park SY, Ahn Y, Lee H, Kim TK, Yoon S, Lee YJ, Oh S, Denninger JW, Kim BN, Kim JH. A Mobile Videoconference-Based Intervention on Stress Reduction and Resilience Enhancement in Employees: Randomized Controlled Trial. J Med Internet Res. 2018 Oct 22;20(10):e10760. doi: 10.2196/10760.
PubMed 30348630
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of a Mobile Video Counseling Targeted for Stress Reduction and Resilience Enhancement in Employees With Emotional Labor
- ClinicalTrials.gov ID
- NCT03256682
- Acronym / sponsor ID
- B-1707-408-305
- Conditions
- Stress, Psychological
- Keywords
- Resilience, Mobile video counseling, Emotiona labor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Trade, Industry & Energy, Republic of Korea
- Study start
- 2 Aug 2017 (actual)
- Primary completion
- 3 Jul 2018 (actual)
- Study completion
- 3 Jul 2018 (actual)
- First posted
- 22 Aug 2017 (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 effectiveness of mobile video counseling for workers. Subjects who can participate in the screening evaluation are assigned to one of face-to-face counseling group, mobile counseling group, and self-treatment group. The mobile counseling group and the face-to-face counseling group counseld with a total of 4 times, 50 minutes at a time, once a week, and 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 test group will conduct a counseling program with a psychologist for 50 minutes at a time, once a week, for a total of 4 sessions (one month for a period). The place should be placed in a quiet place where the subject thinks comfortably and is designated as the same place to exclude the influence by the place, but the subject does not have to visit the hospital. In the offline counseling group, four counseling sessions are held with the psychologist off-line for a total of 4 counseling sessions, 50 minutes at a time, once a week after the same pre-evaluation. As a self-care control, counseling is not provided and self-learning materials are provided once a week.
Mobile counseling group and offline counseling group visit the hospital within one week after termination and within 4 to 5 weeks after pre-evaluation in self-care control group. Also, to see if the effect of mobile counseling is continued even after counseling is completed, visit the counseling clinic one month after counseling is over and conduct the same test. The data obtained from this study showed that the mobile counseling program measured the change in the clinical scale and heart rate variability and EEG such as the stress and resilience of the subjects, and the self-care group using the offline counseling group and stress data and stress related psychological and physiological And compare the effects on the improvement of the indicator.
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 |
|---|---|---|
| Mobile Video Counseling | Experimental | Behavioral: Stress management counselingUtilize mobile imaging equipment, receive a total of 4 stress management consultations every 50 minutes at a time, once a week. |
| Offline Counseling | Active comparator | Behavioral: Stress management counselingReceive a total of 4 stress management counseling, once a week for 50 minutes each session. |
| Selfcare | No intervention | –Use stress management materials to manage yourself. |
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., if the stabilizer 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 counselingstress management counseling based on CBT and relaxation | Behavioural | Mobile Video Counseling, Offline Counseling |
Primary outcome
Change from baseline Perceived Stress Scale (PSS) score at 4, 8 weeks
Time frame: Baseline and after 4, 8 weeks later
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.
9 secondary outcomes
Change from baseline Korean Emotional Labor Assessment Tool score at 4, 8 weeks
Time frame: Baseline and after 4, 8 weeks later
Change from baseline Korean abbreviation of Occupational Stress Scale (KOSS) score at 4, 8 weeks
Time frame: Baseline and after 4, 8 weeks later
Change from baseline Patient Health Questionnaire 9 (PHQ-9) score at 4, 8 weeks
Time frame: Baseline and after 4, 8 weeks later
Change from baseline Brief resilience scale (BRS) score at 4, 8 weeks
Time frame: Baseline and after 4, 8 weeks later
Change from baseline Athens Insomnia Scale (AIS) score at 4, 8 weeks
Time frame: Baseline and after 4, 8 weeks later
Change from baseline Depression, Anxiety, Stress Scale (DASS) score at 4, 8 weeks
Time frame: Baseline and after 4, 8 weeks later
Change from baseline Connor-Davidson Resilience Scale (CD-RISC) score at 4, 8 weeks
Time frame: Baseline and after 4, 8 weeks later
Change from baseline Maslach Burnout Inventory-General Survey (MBI-GS) score at 4, 8 weeks
Time frame: Baseline and after 4, 8 weeks later
Change from baseline Heart rate variability (HRV) and Change from baseline Eletroencephalogram (EEG) score at 4, 8 weeks
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 5 Apr 2019.
- Derived from this study: PubMed 32627860Kunzler AM, Helmreich I, Chmitorz A, Konig J, Binder H, Wessa M, Lieb K. Psychological interventions to foster resilience in healthcare professionals. Cochrane Database Syst Rev. 2020 Jul 5;7(7):CD012527. doi: 10.1002/14651858.CD012527.pub2.
- Derived from this study: PubMed 30348630Kim JI, Yun JY, Park H, Park SY, Ahn Y, Lee H, Kim TK, Yoon S, Lee YJ, Oh S, Denninger JW, Kim BN, Kim JH. A Mobile Videoconference-Based Intervention on Stress Reduction and Resilience Enhancement in Employees: Randomized Controlled Trial. J Med Internet Res. 2018 Oct 22;20(10):e10760. doi: 10.2196/10760.
- Individual participant dataSharing planned: Undecided
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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 counseling 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 5 Apr 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 NCT03256682, which also lists 2 linked publications.
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 5 Apr 2019.