UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053571 |
|---|---|
| Receipt number | R000060792 |
| Scientific Title | Effects of the health educations to improve employees' help-seeking for mental health in small enterprises |
| Date of disclosure of the study information | 2024/02/09 |
| Last modified on | 2025/10/06 11:56:30 |
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Basic information
Public title
Effects of the health educations to improve employees' help-seeking for mental health in small enterprises
Acronym
Effects of the health educations to improve employees' help-seeking for mental health in small enterprises
Scientific Title
Effects of the health educations to improve employees' help-seeking for mental health in small enterprises
Scientific Title:Acronym
Effects of the health educations to improve employees' help-seeking for mental health in small enterprises
Region
| Japan |
Condition
Condition
Employees
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effects of the health educations to improve employees' help-seeking for mental health in small enterprises
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Help-seeking attitudes, Help-seeking intentions, Efficacy of help-seeking
Key secondary outcomes
Knowledge of mental health in workplace
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) 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
Health education video to improve help-seeking for mental health
Interventions/Control_2
Health education leaflet to improve help-seeking of mental health
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Working at small enterprise
2.Aged from 20 to 60
Key exclusion criteria
1.Being in a manager position
2.Receiving treatment for a mental health disorder
3.Have been diagnosed or treated with a mental health disorder in the past
4.Have consulted an occupational health department at workplace or professional organization outside the workplace about mental health problems in the past
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Susumu |
| Middle name | |
| Last name | Fukita |
Organization
National Institute of Public Health
Division name
Department of Health Promotion
Zip code
351-0197
Address
2-3-6 Minami, Wako-shi, Saitama
TEL
048-458-6279
fukita.s.sm@niph.go.jp
Public contact
Name of contact person
| 1st name | Susumu |
| Middle name | |
| Last name | Fukita |
Organization
National Institute of Public Health
Division name
Department of Health Promotion
Zip code
351-0197
Address
2-3-6 Minami, Wako-shi, Saitama
TEL
048-458-6279
Homepage URL
fukita.s.sm@niph.go.jp
Sponsor or person
Institute
National Institute of Public Health
Institute
Department
Personal name
Funding Source
Organization
MEXT(Japan)
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
Research Ethics Committee of the National Institute of Public Health
Address
2-3-6 Minami, Wako-shi, Saitama
Tel
048-458-6186
hagiwara.t.aa@niph.go.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
| 2024 | Year | 02 | Month | 09 | 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
308
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
Completed
Date of protocol fixation
| 2023 | Year | 11 | Month | 21 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 21 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 14 | Day |
Last follow-up date
| 2024 | 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
| 2024 | Year | 02 | Month | 07 | Day |
Last modified on
| 2025 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060792
