UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045473 |
|---|---|
| Receipt number | R000051903 |
| Scientific Title | Development of an effective mental health support program in small and medium-sized businesses |
| Date of disclosure of the study information | 2022/02/28 |
| Last modified on | 2024/03/22 19:51:48 |
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Basic information
Public title
Development of an effective mental health support program in small and medium-sized businesses
Acronym
Development of an effective mental health support program in small and medium-sized businesses
Scientific Title
Development of an effective mental health support program in small and medium-sized businesses
Scientific Title:Acronym
Development of an effective mental health support program in small and medium-sized businesses
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to develop a simple positive mental health promotion program and to verify its effectiveness for small businesses which have been greatly affected by the COVID-19 pandemic.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Utrecht Work Engagement Scale shortened version
Key secondary outcomes
General Health Questionnaire, stress check, sleep time and heart rate variability data, Changes in communication
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Training for positive mental health using lecture and role-play
Interventions/Control_2
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
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Employees working in workplaces where the number of workers is less than 50
Key exclusion criteria
Nothing
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yumiko |
| Middle name | |
| Last name | Matsushima |
Organization
Kobe Gakuin University
Division name
The Faculty of Psychology
Zip code
651-2180
Address
518 Arise, Ikawadani-cho, Nishi-ku, Kobe
TEL
078-974-1551
matsushima@psy.kobegakuin.ac.jp
Public contact
Name of contact person
| 1st name | Yumiko |
| Middle name | |
| Last name | Matsushima |
Organization
Kobe Gakuin University
Division name
The Faculty of Psychology
Zip code
651-2180
Address
518 Arise, Ikawadani-cho, Nishi-ku, Kobe
TEL
078-974-1551
Homepage URL
matsushima@psy.kobegakuin.ac.jp
Sponsor or person
Institute
Kobe Gakuin University
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research-KAKENHI-
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
Kobe Gakuin University
Address
518 Arise, Ikawadani-cho, Nishi-ku, Kobe
Tel
078-974-6246
shinri@j.kobegakuin.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
| 2022 | Year | 02 | Month | 28 | 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
10
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
Terminated
Date of protocol fixation
| 2021 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 27 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 28 | 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
| 2021 | Year | 09 | Month | 13 | Day |
Last modified on
| 2024 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051903
