UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053029 |
|---|---|
| Receipt number | R000060493 |
| Scientific Title | Verification of the Effectiveness of a Psychological Support Program to Protect the Morals of Health Care Workers |
| Date of disclosure of the study information | 2023/12/07 |
| Last modified on | 2023/12/07 12:49:29 |
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Basic information
Public title
Verification of the Effectiveness of a Psychological Support Program to Protect the Morals of Health Care Workers
Acronym
Verification of the Effectiveness of a Psychological Support Program to Protect the Morals of Health Care Workers
Scientific Title
Verification of the Effectiveness of a Psychological Support Program to Protect the Morals of Health Care Workers
Scientific Title:Acronym
Moral Psychological Support Program Test
Region
| Japan |
Condition
Condition
Moral distress, Moral injury
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to test the effectiveness of a psychological support program to help healthcare workers to learn cognitive modification and coping behaviors to maintain their morals.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Japanese Version of the Measure of Moral Distress for Healthcare Professionals
Japanese Version of Rushton Moral Resilience Scale
Key secondary outcomes
The Kessler Psychological Distress Scale
Resilience Scale
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
1. Training
Learn about moral distress and moral injury and how to deal with it through e-learning. (90 min. lecture)
Reflect on cases with solution sheets in group work via online. (120 minutes of group work)
2. 1 month waiting period
Interventions/Control_2
Control Group
1. 1 month waiting period
2. Training
Learn about moral distress and moral injury and how to deal with it through e-learning. (90 min. lecture)
Reflect on cases with solution sheets in group work via online. (120 minutes of group work)
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthcare worker working in a hospital in Japan.
Key exclusion criteria
K6 (Kessler Psychological Distress Scale) cut-off value of 13 or more points
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Hirokazu |
| Middle name | |
| Last name | Tachikawa |
Organization
University of Tsukuba
Division name
Department of Disaster and Community Psychiatry, Institute of Medicine
Zip code
305-8575
Address
1-1-1Tennodai, Tsukuba,Ibaraki,Japan
TEL
0298533343
tachikawa@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Wataya |
Organization
University of Tsukuba Faculty of Comprehensive Human Sciences
Division name
Department of Disaster and Community Psychiatry, Institute of Medicine
Zip code
305-8575
Address
1-1-1Tennodai, Tsukuba,Ibaraki,Japan
TEL
0298533343
Homepage URL
keiko.wataya.tsukuba@gmail.com
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Institute of Medicine, University of Tsukuba
Address
1-1-1Tennodai, Tsukuba,Ibaraki,Japan
Tel
0298533022
sien.ningenss@un.tsukuba.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
| 2023 | Year | 12 | Month | 07 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 18 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 12 | Month | 07 | Day |
Last modified on
| 2023 | Year | 12 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060493
| Research Plan | |
|---|---|
| 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 |
