- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04857567
The Efficacy Study of the Evidence-Based Psychological Intervention for Improving Resilience and Preventing Burnout of Residents
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Heung-Kwon Oh, PhD
- Phone Number: +82-31-787-7105
- Email: crsohk@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Subjects who do not consent to the study
- Subjects with meditation experience
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Three Self-Commitment (TSC) program
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
Change from baseline at right after 6 cycles of TSC program (up to 24 weeks from baseline)
|
|
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. |
Change from baseline at right after 6 cycles of TSC program (up to 24 weeks from baseline)
|
|
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. |
Change from baseline at right after 6 cycles of TSC program (up to 24 weeks from baseline)
|
|
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). |
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
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. |
Change from baseline at right after 6 cycles of TSC program (up to 24 weeks from baseline)
|
|
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)
|
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)
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Heung-Kwon Oh, PhD, Seoul National University Bundang Hospital
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- B-2007/624-304
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Burn Out (Psychology)
-
Chinese University of Hong KongCity University of Hong KongCompleted
-
University of North Carolina, Chapel HillCompleted
-
Cukurova UniversityCompletedMindfulness Meditation | Burn Out (Psychology) | Self CompassionTurkey
-
Services Hospital, LahoreCompletedBurn Out SyndromePakistan
-
Services Hospital, LahoreCompletedBurn Out SyndromePakistan
-
AdventHealthCompleted
-
Tulane UniversityCompleted
-
University Hospital, MontpellierCompletedSimulation | Quality of Work Life | Burn-outFrance
-
Saint-Louis Hospital, Paris, FranceCompletedPrevalence of Burn-out Among Intensive Care ProfessionalsBelgium
-
Medical University of GrazRecruitingDepressive Disorder | Sleep | Psychological Stress | Nutritional Quality | Burn-out SyndromeAustria
Clinical Trials on TSC program (Three Self-Commitment program)
-
Azienda Sanitaria Locale CN1 CuneoRecruiting
-
Radboud University Medical CenterCompleted
-
University of North Carolina, Chapel HillCenters for Disease Control and PreventionCompletedChronic DiseaseUnited States
-
Cairo UniversityCompletedSpastic Cerebral Palsy | Management | Serial Casting | Lower Limb DeformitiesEgypt
-
University of North Carolina, Chapel HillAmerican Diabetes AssociationNot yet recruitingType 2 Diabetes Mellitus (T2DM) | Diabetes (DM) | Insulin Dependent Diabetes | Type 1 Diabetes (T1D) | Diabetes Education | Diabetes Care | Diabetes (Insulin-requiring, Type 1 or Type 2)United States
-
Yuanpei University of Medical TechnologyCompletedLow Back Pain | Postural Imbalance | Pelvic MalalignmentTaiwan
-
Chang Gung Memorial HospitalCompleted
-
Assistance Publique - Hôpitaux de ParisRecruitingQuality of Life | Facial Palsy | Motor Recovery | Self-rehabilitationFrance
-
Rush University Medical CenterUniversity of Colorado, Denver; Geisinger Clinic; University of Missouri, Kansas... and other collaboratorsCompleted
-
Poznan University of Physical EducationCompleted