The Efficacy Study of the Evidence-Based Psychological Intervention for Improving Resilience and Preventing Burnout of Residents

July 21, 2021 updated by: Heung-Kwon Oh, Seoul National University Hospital
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Heung-Kwon Oh, PhD
  • Phone Number: +82-31-787-7105
  • Email: crsohk@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Three Self-Commitment (TSC) program
Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seoul National University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Mind Works Clinical Psychologist Group

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Heung-Kwon Oh, PhD, Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 7, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 23, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 28, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B-2007/624-304

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings