UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059804 |
|---|---|
| Receipt number | R000068193 |
| Scientific Title | Effects of a Workplace Psychological Safety Training Program: A Cluster Randomized Controlled Trial |
| Date of disclosure of the study information | 2025/11/18 |
| Last modified on | 2025/11/18 04:33:15 |
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Basic information
Public title
Effects of a Workplace Psychological Safety Training Program for Managers on Improving Psychological Distress Among Team Members: A Cluster Randomized Controlled Trial
Acronym
Effects of a Workplace Psychological Safety Training Program for Managers on Improving Psychological Distress Among Team Members: A Cluster Randomized Controlled Trial
Scientific Title
Effects of a Workplace Psychological Safety Training Program: A Cluster Randomized Controlled Trial
Scientific Title:Acronym
Effects of a Workplace Psychological Safety Training Program: A Cluster Randomized Controlled Trial
Region
| Japan |
Condition
Condition
N/A
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Psychological safety in the workplace is a critical factor that contributes to organizational learning and performance improvement by fostering a culture where employees feel comfortable speaking up and learning from mistakes (Edmondson, 1999). An Observational study has shown that high psychological safety is associated with better employee mental health and their higher productivity (Sasaki et al., 2022). However, the efficacy of workplace interventions to improve psychological safety remains unclear. Therefore, this study aims to assess the efficacy of a training program provided to managers, utilizing a workplace psychological safety improvement program, in improving subordinates' psychological stress responses through a cluster randomized controlled trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Kessler 6-Item Psychological Distress Scale: K6
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Managers receive weekly video deliveries (15 minutes each) for four weeks and email newsletters for two months. Employees receive basic information about psychological safety via email. The videos focus on psychological safety through case scenarios, while the newsletters offer video reviews and four-panel comics.
Interventions/Control_2
Both managers and employees receive brief mental health self-care materials (PDF files).
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cluster (Workplace) Inclusion Criteria:
1.The workplace has at least one manager/leader (supervisor position) with one or more direct reports.
Individual (Worker) Inclusion Criteria:
1. 18 years old or older
2. Able to answer a questionnaire written in Japanese
3. Has one or more direct reports, or one or more direct managers/leaders (supervisor position), and works at the same workplace as that person (job type does not matter)
Key exclusion criteria
Exclusion Criteria for Individuals (Workers):
1. Currently on leave
2. having one month or more of leave due to illness within the past 12 months
Target sample size
1320
Research contact person
Name of lead principal investigator
| 1st name | Kotaro |
| Middle name | |
| Last name | Imamura |
Organization
The University of Tokyo
Division name
Department of Digital Mental Health, Graduate School of Medicine
Zip code
1138655
Address
7-3-1, Hongo, Bunkyoku, Tokyo
TEL
03-5800-9621
kouima-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Kotaro |
| Middle name | |
| Last name | Imamura |
Organization
The University of Tokyo
Division name
Department of Digital Mental Health, Graduate School of Medicine
Zip code
1138655
Address
7-3-1, Hongo, Bunkyoku, Tokyo
TEL
03-5800-9621
Homepage URL
kouima-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Kotaro Imamura
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Research Ethics Review Board of Graduate School of Medicine/Faculty of Medicine, the University of Tokyo
Address
7-3-1, Hongo, Bunkyoku, Tokyo
Tel
03-5841-0818
ethics@m.u-tokyo.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
| 2025 | Year | 11 | Month | 18 | 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
| 2025 | Year | 11 | Month | 17 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 13 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 18 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 11 | Month | 18 | Day |
Last modified on
| 2025 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068193
