UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046960 |
|---|---|
| Receipt number | R000053570 |
| Scientific Title | Effects of the implementation strategy of Internet-based self-guided stress management program "WellBe-LINE" in micro and small-sized enterprises |
| Date of disclosure of the study information | 2022/02/21 |
| Last modified on | 2022/08/22 14:56:41 |
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Basic information
Public title
Effects of the implementation strategy of Internet-based self-guided stress management program "WellBe-LINE" in micro and small-sized enterprises
Acronym
Effects of the implementation strategy of Internet-based self-guided stress management program "WellBe-LINE" in micro and small-sized enterprises
Scientific Title
Effects of the implementation strategy of Internet-based self-guided stress management program "WellBe-LINE" in micro and small-sized enterprises
Scientific Title:Acronym
Effects of the implementation strategy of Internet-based self-guided stress management program "WellBe-LINE" in micro and small-sized enterprises
Region
| Japan |
Condition
Condition
Psychological distress
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the implementation outcome of the Internet-based self-guided stress management program and effects on psychological distress among users in micro and small-sized enterprises.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
<Implementation outcome>
Individual-level penetration
The number of workers who actually started using the program in recruited companies (the number of recruited companies whose at least 60% of workers used the program was more than 50%).
Key secondary outcomes
<Implementation Outcome>
Individual-level acceptability
Individual-level appropriateness
Individual-level feasibility
Individual-level costs
Company-level adoption
Company-level acceptability
Company-level appropriateness
Company-level feasibility
Company-level costs
Recruiter (provider)-level adoption
Recruiter (provider)-level acceptability
Recruiter (provider)-level appropriateness
Recruiter (provider)-level feasibility
Recruiter (provider)-level costs
<Health Outcome (Effectiveness)>
Users' psychological stress response (K6)
Work performance (HPQ)
Work Engagement (UWES-3)
Job satisfaction
Good relationship with co-workers
Euthymia
<Process Outcome>
Friend block rate
How many times did you read the message?
Did you feel that the company cares about its employees?
Trust in management
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
Prevention
Type of intervention
| Other |
Interventions/Control_1
Using the Internet-based self-guided stress management program.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Organization: company having less than 50 employees.
Individual: employees who are 18 years of age or older employed at an enterprise with less than 50 employees.
Key exclusion criteria
none
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kotaro |
| Middle name | |
| Last name | Imamura |
Organization
The University of Tokyo
Division name
Graduate school of medicine, Department of mental health
Zip code
113-0033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033,
TEL
03-5841-3364
kouima-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Natsu |
| Middle name | |
| Last name | Sasaki |
Organization
The University of Tokyo
Division name
Graduate school of medicine, Department of mental health
Zip code
113-0033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033,
TEL
03-5841-3364
Homepage URL
nasasaki-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare, Japan, Industrial Disease Clinical Research Grants [Grant Number 200401-01]
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
Office for Human Research Studies, Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033,
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
| 2022 | Year | 02 | Month | 21 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 17 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 21 | Day |
Last follow-up date
| 2021 | Year | 08 | 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
| 2022 | Year | 02 | Month | 21 | Day |
Last modified on
| 2022 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053570
