UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059327 |
|---|---|
| Receipt number | R000067862 |
| Scientific Title | Effectiveness of Supervisor Training in Reducing Stigma Toward Mental Health Problems:Randomized Controlled Trial |
| Date of disclosure of the study information | 2025/10/08 |
| Last modified on | 2025/10/08 07:36:36 |
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Basic information
Public title
Effectiveness of Supervisor Training in Reducing Stigma Toward Mental Health Problems:Randomized Controlled Trial
Acronym
Effectiveness of Supervisor Training in Reducing Stigma Toward Mental Health Problems:Randomized Controlled Trial
Scientific Title
Effectiveness of Supervisor Training in Reducing Stigma Toward Mental Health Problems:Randomized Controlled Trial
Scientific Title:Acronym
Effectiveness of Supervisor Training in Reducing Stigma Toward Mental Health Problems:Randomized Controlled Trial
Region
| Japan |
Condition
Condition
No applicable
Adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This randomized controlled trial aims to evaluate the effectiveness of Supervisor Training in reducing stigma toward mental health problems.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stigma toward mental health problems will be measured at three time points (baseline, post-intervention, and 2-month follow-up) using the Japanese version of the Link Stigma Scale (Shimotsu, 2006).
Key secondary outcomes
1. Knowledge regarding mental health problems
2. Attitudes toward mental health problems
3. Behavior toward individuals with mental health problems
4. Mental health literacy
5. Social distance
6. Psychological safety
All measures will be assessed at three time points:
- Before random allocation
- Immediately after the intervention
- Two months post-intervention
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
This study aims to reduce stigma associated with mental health problems in the workplace. A 120-minute face-to-face training session will be implemented as the intervention. The target participants are supervisors, and the program is structured to specifically address stigma related to depression. The contents of the training program are as follows:
- The role of managerial staff in Supervisor Training
- Knowledge of mental health problems such as depression
- Approaches to supporting employees experiencing mental health problems
- Viewing an interview video in which a person in remission from depression shares their recovery experience
Interventions/Control_2
Wait list control condition
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
managerial staff
Key exclusion criteria
None
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shinobu |
| Middle name | |
| Last name | Watanabe |
Organization
University of Tsukuba
Division name
Master's Program in Counseling Science, , Graduate School of Comprehensive Human Sciences
Zip code
1120012
Address
3-29-1 Otsuka, Bunkyo-ku, Tokyo, Japan
TEL
+81-3-3942-6852
s2440224@u.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Shinobu |
| Middle name | |
| Last name | Watanabe |
Organization
University of Tsukuba
Division name
Master's Program in Counseling Science, , Graduate School of Comprehensive Human Sciences
Zip code
1120012
Address
3-29-1 Otsuka, Bunkyo-ku, Tokyo, Japan
TEL
+81-3-3942-6852
Homepage URL
s2440224@u.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
None
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 of the Faculty of Human Sciences, Tokyo Branch, University of Tsukuba
Address
3-29-1 Otsuka, Bunkyo-ku, Tokyo, Japan
Tel
+81-3-3942-6919
hitorinri@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
| 2025 | Year | 10 | Month | 08 | 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
100
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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 07 | Month | 28 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 28 | Day |
Last follow-up date
| 2026 | 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 | 10 | Month | 08 | Day |
Last modified on
| 2025 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067862
