UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038602 |
|---|---|
| Receipt number | R000043982 |
| Scientific Title | The effects of acceptance and commitment training to medical student burnout in clinical years;An observational study. |
| Date of disclosure of the study information | 2019/11/17 |
| Last modified on | 2023/09/15 12:57:40 |
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Basic information
Public title
The effects of acceptance and commitment training to medical student burnout in clinical years;An observational study.
Acronym
The effects of acceptance and commitment training to medical student burnout in clinical years;An observational study.
Scientific Title
The effects of acceptance and commitment training to medical student burnout in clinical years;An observational study.
Scientific Title:Acronym
The effects of acceptance and commitment training to medical student burnout in clinical years;An observational study.
Region
| Japan |
Condition
Condition
burnout
Classification by specialty
| Psychiatry | Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effect of acceptance and commitment training to medical student burnout in clinical years will be examined by exploratory study design.
Basic objectives2
Others
Basic objectives -Others
1.The effect of acceptance and commitment training to medical students' depression, anxiety, psychological flexibility, and empathy between medical students and patients in clinical years will be examined by exploratory study.
2.The predictor of acceptance and commitment training to medical student burnout will be examined by cohort study design.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Each score of Maslach Burnout Inventory.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Medical students who have passed Computer Based Testing (CBT) and Objective Structured Clinical Examination (OSCE) and have participated in BSL and have attended Acceptance and Commitment Training (one 2-hour session, 3 sessions, 1-2 months in total).
Key exclusion criteria
1. The score of Patient Health Questionnaire(PHQ)-9 was above 15.
2. The score of PHQ-9 was above 10 and the item No.9 was 2 or 3.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Takafumi |
| Middle name | |
| Last name | Watanabe |
Organization
Nagoya City Univ Graduate School of Medical Sciences
Division name
Department of Psychiatry
Zip code
467-8601
Address
1, Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
TEL
+81-52-851-5511
tw28@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Takafumi |
| Middle name | |
| Last name | Watanabe |
Organization
Nagoya City Univ Graduate School of Medical Sciences
Division name
Department of Psychiatry
Zip code
467-8601
Address
1, Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
TEL
+81-52-851-5511
Homepage URL
tw28@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City Univ Graduate School of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Nagoya City Univ Graduate School of Medical Sciences
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical research management center, Nagoya City University Hospital
Address
Nagoya City Univ Graduate School of Medical Sciences
Tel
+81-52-853-8271
clinical_research@med.nagoya-cu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 11 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2019 | Year | 09 | Month | 26 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 25 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observation items
Demographic characteristics data: age, gender, and department of interest
Burnout: Maslach Burnout Inventory (MBI)
Depression: Patient Health Questionnaire (PHQ)-9
Psychological flexibility (value-aligned behavior): Valuing Questionnaire (VQ)
Psychological Flexibility (Mindfulness): the Mindful Attention Awareness Scale (MAAS)
Psychological flexibility (cognitive fusion): Cognitive Fusion Questionnaire (CFQ)
Perfectionism Cognitions: the Multidimensional Perfectionism Cognitions Inventory (MPCI)
Physician-Patient Empathy: The Jefferson Scale of Physician Empathy (JSPE)
Developmental Characteristics: Autism-Spectrum Quotinent (AQ)-10
Developmental Characteristics: Adult ADHD Self Report Scale (ASRS) Part A
Psychological flexibility (cognitive fusion): response latency measurement of congruent and incongruent enforcement by the Implicit Relational Assessment Procedure (IRAP).
Satisfaction with the program
History of psychological training, including ACT
Management information
Registered date
| 2019 | Year | 11 | Month | 16 | Day |
Last modified on
| 2023 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043982
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
