UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045457 |
|---|---|
| Receipt number | R000051901 |
| Scientific Title | The effect of Mental Health Promotion Program for middle managers: a cluster randomized controlled trial--preliminary study |
| Date of disclosure of the study information | 2021/09/13 |
| Last modified on | 2025/03/21 14:42:15 |
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Basic information
Public title
The effect of Mental Health Promotion Program for middle managers
Acronym
Mental Health Promotion Program
Scientific Title
The effect of Mental Health Promotion Program for middle managers: a cluster randomized controlled trial--preliminary study
Scientific Title:Acronym
Mental Health Promotion Program--preliminary study
Region
| Japan |
Condition
Condition
mental health
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Can the Mental Health Promotion Program promote the mental health of middle managers and employees?
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase III
Assessment
Primary outcomes
General Well-being Schedule score of middle managers after 6 months and a year
Key secondary outcomes
General Well-being Schedule score of employees after 6 months and a year
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
3 hours psycho-education and social skills training
Interventions/Control_2
no treatment
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
informed consented middle managers and employees
Key exclusion criteria
the score of the Center for Epidemiologic Studies Depression Scale > 31
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Amagasa |
Organization
Shizuoka graduate school of public health
Division name
Department of public health
Zip code
420-0881
Address
4-27-2 Kitaanndo Aoi-ku Shizuoka
TEL
054-295-5400
amagasa_t@s-sph.ac.jp
Public contact
Name of contact person
| 1st name | Personnel |
| Middle name | |
| Last name | Registrar |
Organization
Shizuoka graduate school of public health
Division name
Registrar
Zip code
420-0881
Address
4-27-2 Kitaanndo Aoi-ku Shizuoka
TEL
054-295-5400
Homepage URL
info@s-sph.ac.jp
Sponsor or person
Institute
Shizuoka graduate school of public health
Institute
Department
Personal name
Funding Source
Organization
Shizuoka graduate school of public health
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
IRB of Shizuoka graduate school of public health
Address
4-27-2 Kitaanndo Aoi-ku Shizuoka
Tel
054-295-5400
info@s-sph.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
| 2021 | Year | 09 | Month | 13 | 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
206
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
| 2021 | Year | 07 | Month | 06 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 06 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 06 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 06 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 25 | Day |
Date trial data considered complete
| 2024 | Year | 01 | Month | 19 | Day |
Date analysis concluded
| 2024 | Year | 08 | Month | 03 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 09 | Month | 12 | Day |
Last modified on
| 2025 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051901
