Burn Out (Psychology)NCT04857567
The Efficacy Study of the Evidence-Based Psychological Intervention for Improving Resilience and Preventing Burnout of Residents
A study testing TSC program (Three Self-Commitment program) in people with Burn Out (Psychology), run by Seoul National University Hospital.
Trial summary
There are few systematic studies on the working environment and mental health of residents who are at the forefront of Korean medical care. In particular, there is no scientific research on burnout prevention. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Burn Out (Psychology)
- What is being tested?
- TSC program (Three Self-Commitment program)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2021to 31 Jul 2022
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Surgical trainees (residents and clinical fellows) at Bundang Seoul National University Hospital, who is 20 years of age or older, regardless of sex or race.
Who cannot join
- Subjects who do not consent to the study
- Subjects with meditation experience
Trial locations and contacts
No sites are listed yet.
About this study
There are few systematic studies on the working environment and mental health of residents who are at the forefront of Korean medical care. In particular, there is no scientific research on burnout prevention. Since preventing burnout of surgical residents is directly related not only to personal well-being but the health of the patients, it is necessary to care for the individual's psychological state at a social level. This psychological intervention program that is expected to improve recovery resilience in stressful situations of residents and prevent burnout is implemented, and its effectiveness is to be verified.
- Conditions
- Burn Out (Psychology)
- Being tested
- TSC program (Three Self-Commitment program)
- Keywords
- resident, surgery, ego resilience, mindfulness
- Medical subject headings
- Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TSC program (Three Self-Commitment program)Behavioural
- Self-Competence program
- A program for residents who experience exhaustion due to the spirit of volunteerism and high expectations of therapeutic competency in the case of experiencing a decrease in personal achievement.
- Self-Care program
- A program to help individuals who experience dehumanization due to emotional suppression and develop exhaustion in the process of suppressing emotions to protect themselves from excessive feelings of compassion experienced in the medical scene
- Self-Compassion program - A program for residents who experience emotional burnout and exhaustion due to pressure of failure because medical professionals should be competent and excellent
| Study group | Role | What they receive |
|---|---|---|
| Three Self-Commitment (TSC) program | Experimental | Not described Receives: Behavioral: TSC program (Three Self-Commitment program) |
What is being measured
The primary outcome is the main question the study is designed to answer.
TCI, Temperament and Character Inventory
A test developed by Clononger, Przybeck, Svrakic and Wetzel (1994) and currently widely used in various countries such as the United States, France, and Spain.
A tool that measures personality traits such as autonomy, solidarity, and self-transcendence, along with individual traits such as stimulation seeking, risk aversion, social sensitivity, and endurance. In this study, the Korean version (Min et al., 2007) of the German version of TCI-RS, the standardized test, is adapted : Based on the test result, the individual's personality characteristics of the resident are identified and applied.
Measured: Change from baseline at right after 6 cycles of TSC program (up to 24 weeks from baseline)
MBI, Maslach Burnout Inventory
As a test developed by Maslach and Jackson (1981), MBI is a tool that measures the sub-concepts of burnout, such as emotional burnout, dehumanization, and personal sense of accomplishment.
MBI is a measurement tool used in more than 90% of empirical exhaustion research worldwide, and a test developed to measure the exhaustion of personnel providing interpersonal services including medical workers.
In this study, MBI adapted and validated by Kang Jeong-hee and Kim Cheol-woong (2012) is used. Participate in the program according to the type of burnout of the client and measure the change in the burnout level of the participants before and after.
Measured: Change from baseline at right after 6 cycles of TSC program (up to 24 weeks from baseline)
ER89, Ego Resilience Scale
A test developed by Block and Kremen (1996) that measures sub-concepts of self-elasticity such as interpersonal relationships, vitality, emotional control, curiosity, and optimism.
In this study, a scale adapted by Park Eun-hee (1997), which was verified as 76-79, is used and measures the change in the participant's ego-elasticity before and after participating in the program.
Measured: Change from baseline at right after 6 cycles of TSC program (up to 24 weeks from baseline)
DASS-21, Depression Anxiety StressScale
A test developed by Lovibond and Lovibond (1995) to measure depression, anxiety, and stress corresponding to psychological distress.
The internal agreement was verified as 0.87~0.91, 0.83~0.89, and 0.83~0.92 for depression, anxiety, and stress, respectively (Youngsun Lee et al, 2019; Jun et al, 2018).
Measured: In this study, changes in participant's psychological pain are measured at each session during the program (6 cycles of TSC program, 3-4 weeks interval, up to 24 weeks from baseline).
Subjective Well-being
A test developed by Diener E (1985) to measure subjective satisfaction with daily life.
A tool showing the internal consistency reliability of 0.87 and the test-retest reliability of 0.82.
Measured: Change from baseline at right after 6 cycles of TSC program (up to 24 weeks from baseline)
SCS, Self-Compassion Scale
Developed by Neff (2003) and validated as a Korean version by Kim et al. (2008) / 26 items / 6 sub-factors: self-kindness, self-judgment, universal humanity, isolation, mindfulness, hyper-identification on a 5-point scale (minimum 6 to maximum 30, the higher the score, the better the outcome)
Measured: Change from baseline at right after 6 cycles of TSC program at the end of Cycle 6 (each cycle is 4 weeks, up to 24 weeks from baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start1 Sep 2021 (estimated)
- Primary completion28 Feb 2022 (estimated)
- Study completion31 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burn Out (Psychology)Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Mind Works Clinical Psychologist Group
- Responsible party
- Principal investigator, Heung-Kwon Oh, Seoul National University Hospital
- Investigators
- Heung-Kwon Oh, PhD, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04857567
- Sponsor's protocol ID
- B-2007/624-304
- Status last verified
- Jul 2021
- First submitted
- 7 Apr 2021
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy Study of the Evidence-Based Psychological Intervention for Improving Resilience and Preventing Burnout of Residents
- ClinicalTrials.gov ID
- NCT04857567
- Acronym / sponsor ID
- B-2007/624-304
- Conditions
- Burn Out (Psychology)
- Keywords
- resident, surgery, ego resilience, mindfulness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Mind Works Clinical Psychologist Group
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 28 Feb 2022 (estimated)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 23 Apr 2021 (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.
There are few systematic studies on the working environment and mental health of residents who are at the forefront of Korean medical care. In particular, there is no scientific research on burnout prevention. Since preventing burnout of surgical residents is directly related not only to personal well-being but the health of the patients, it is necessary to care for the individual's psychological state at a social level. This psychological intervention program that is expected to improve recovery resilience in stressful situations of residents and prevent burnout is implemented, and its effectiveness is to be verified.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Three Self-Commitment (TSC) program | Experimental | Behavioral: TSC program (Three Self-Commitment program) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Surgical trainees (residents and clinical fellows) at Bundang Seoul National University Hospital, who is 20 years of age or older, regardless of sex or race.
Key exclusion criteria (2 listed)
- Subjects who do not consent to the study
- Subjects with meditation experience
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 |
|---|---|---|
| TSC program (Three Self-Commitment program)1. Self-Competence program - A program for residents who experience exhaustion due to the spirit of volunteerism and high expectations of therapeutic competency in the case of experiencing a decrease in personal achievement. 2. Self-Care program - A program to help individuals who experience dehumanization due to emotional suppression and develop exhaustion in the process of suppressing emotions to protect themselves from excessive feelings of compassion experienced in the medical scene 3. Self-Compassion program - A program for residents who experience emotional burnout and exhaustion due to pressure of failure because medical professionals should be competent and excellent | Behavioural | Three Self-Commitment (TSC) program |
Primary outcome
TCI, Temperament and Character Inventory
Time frame: Change from baseline at right after 6 cycles of TSC program (up to 24 weeks from baseline)
A test developed by Clononger, Przybeck, Svrakic and Wetzel (1994) and currently widely used in various countries such as the United States, France, and Spain. A tool that measures personality traits such as autonomy, solidarity, and self-transcendence, along with individual traits such as stimulation seeking, risk aversion, social sensitivity, and endurance. In this study, the Korean version (Min et al., 2007) of the German version of TCI-RS, the standardized test, is adapted : Based on the test result, the individual's personality characteristics of the resident are identified and applied.
MBI, Maslach Burnout Inventory
Time frame: Change from baseline at right after 6 cycles of TSC program (up to 24 weeks from baseline)
As a test developed by Maslach and Jackson (1981), MBI is a tool that measures the sub-concepts of burnout, such as emotional burnout, dehumanization, and personal sense of accomplishment. MBI is a measurement tool used in more than 90% of empirical exhaustion research worldwide, and a test developed to measure the exhaustion of personnel providing interpersonal services including medical workers. In this study, MBI adapted and validated by Kang Jeong-hee and Kim Cheol-woong (2012) is used. Participate in the program according to the type of burnout of the client and measure the change in the burnout level of the participants before and after.
ER89, Ego Resilience Scale
Time frame: Change from baseline at right after 6 cycles of TSC program (up to 24 weeks from baseline)
A test developed by Block and Kremen (1996) that measures sub-concepts of self-elasticity such as interpersonal relationships, vitality, emotional control, curiosity, and optimism. In this study, a scale adapted by Park Eun-hee (1997), which was verified as 76-79, is used and measures the change in the participant's ego-elasticity before and after participating in the program.
DASS-21, Depression Anxiety StressScale
Time frame: In this study, changes in participant's psychological pain are measured at each session during the program (6 cycles of TSC program, 3-4 weeks interval, up to 24 weeks from baseline).
A test developed by Lovibond and Lovibond (1995) to measure depression, anxiety, and stress corresponding to psychological distress. The internal agreement was verified as 0.87~0.91, 0.83~0.89, and 0.83~0.92 for depression, anxiety, and stress, respectively (Youngsun Lee et al, 2019; Jun et al, 2018).
Subjective Well-being
Time frame: Change from baseline at right after 6 cycles of TSC program (up to 24 weeks from baseline)
A test developed by Diener E (1985) to measure subjective satisfaction with daily life. A tool showing the internal consistency reliability of 0.87 and the test-retest reliability of 0.82.
SCS, Self-Compassion Scale
Time frame: Change from baseline at right after 6 cycles of TSC program at the end of Cycle 6 (each cycle is 4 weeks, up to 24 weeks from baseline)
Developed by Neff (2003) and validated as a Korean version by Kim et al. (2008) / 26 items / 6 sub-factors: self-kindness, self-judgment, universal humanity, isolation, mindfulness, hyper-identification on a 5-point scale (minimum 6 to maximum 30, the higher the score, the better the outcome)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Burn Out (Psychology)
Not yet recruiting
A Study of a Mental Fitness Intervention for Anesthesiology Resident Wellbeing and Self-Compassion
Wellness, Self Compassion
Not yet recruiting
The INSPIRE Study: INvestigation of Swiss Physicians Inner-life, Resilience, and Emotions
Burnout, Professional, Emotional Exhaustion
Active, not recruiting
Mindful-Med: the Evaluation of the Mindfulness-based Stress-coping and Burnout Prevention Programme for Medical Interns.
Stress (Psychology), Burnout
Recruiting
Character-Strengths Based Coaching For Work-Stress Reduction For Health Workers
Work Related Stress, Burnout, Psychological
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.
Heung-Kwon Oh, PhD principal investigator
Seoul National University Bundang Hospital
Questions about this trial
What is this clinical trial studying?
A study testing TSC program (Three Self-Commitment program) in people with Burn Out (Psychology), run by Seoul National University Hospital.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heung-Kwon Oh, PhD (+82-31-787-7105, crsohk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TCI, Temperament and Character Inventory (time frame: Change from baseline at right after 6 cycles of TSC program (up to 24 weeks from baseline)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2021.