UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050624 |
|---|---|
| Receipt number | R000057552 |
| Scientific Title | Effects of an Internet-based stress management intervention on psychological distress among workers in micro and small-sized enterprises: randomized controlled trial |
| Date of disclosure of the study information | 2023/03/18 |
| Last modified on | 2023/03/18 12:21:05 |
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Basic information
Public title
Effects of an Internet-based stress management intervention on psychological distress among workers in micro and small-sized enterprises: randomized controlled trial
Acronym
Effects of an Internet-based stress management intervention on psychological distress among workers in micro and small-sized enterprises
Scientific Title
Effects of an Internet-based stress management intervention on psychological distress among workers in micro and small-sized enterprises: randomized controlled trial
Scientific Title:Acronym
Effects of an Internet-based stress management intervention on psychological distress among workers in micro and small-sized enterprises
Region
| Japan |
Condition
Condition
Healthy workers
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of the Internet-based self-guided stress management program named "WellBe-LINE" for psychological distress among workers in micro and small-sized enterprises using randomized controlled trial design.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Psychological distress (K6) (8 weeks and 6-month)
Key secondary outcomes
Performance (HPQ) (8 weeks and 6-month)
Work engagement (UWES) (8 weeks and 6-month)
Well-being (NHC-SF) (8 weeks and 6-month)
Euthymia (Euthymia scale) (8 weeks and 6-month)
Sick leave days (8 weeks and 6-month)
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
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
An Internet-based self-administered stress management program ("WellBe-LINE") will be implemented for eight weeks, during which time information provided once a week on LINE app.
Interventions/Control_2
Waitlist
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
1. Adults (Over 18 years old)
2. Full-time employees who are 18 or older employed at an enterprise with less than 50 employees.
3. Those who use a LINE app and are willing to register as a friend with the account for the research.
Key exclusion criteria
none
Target sample size
1200
Research contact person
Name of lead principal investigator
| 1st name | Kotaro |
| Middle name | |
| Last name | Imamura |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Mental Health/Department of Digital Mental Health
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-5800-9621
kouima-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Kotaro |
| Middle name | |
| Last name | Imamura |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Mental Health/Department of Digital Mental Health
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-5800-9621
Homepage URL
kouima-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
The Japan Society for the Promotion of Science (JSPS)
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, Graduate School of Medicine, The University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
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
| 2023 | Year | 03 | Month | 18 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 20 | 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
| 2023 | Year | 03 | Month | 18 | Day |
Last modified on
| 2023 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057552
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
