UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033168 |
|---|---|
| Receipt number | R000037824 |
| Scientific Title | Effects of stress coping program in e-learning for dispatched workers:a randomized controlled trial |
| Date of disclosure of the study information | 2018/12/01 |
| Last modified on | 2023/12/31 09:28:46 |
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Basic information
Public title
Effects of stress coping program in e-learning for dispatched workers:a randomized controlled trial
Acronym
Effects of stress coping program in e-learning for dispatched workers: RCT
Scientific Title
Effects of stress coping program in e-learning for dispatched workers:a randomized controlled trial
Scientific Title:Acronym
Effects of stress coping program in e-learning for dispatched workers: RCT
Region
| Japan |
Condition
Condition
Job stress
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We developed e-learning program on the smartphone for improvement of stress management skills and career awareness, aiming to measure the educational effect for dispatched workers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Judge by which item of which intervention has a significant difference from pre,post(after 1 month),follow-up(after 3 months) average score on "The Brief Job Stress Questionnaire"
Key secondary outcomes
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
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Cognitive reframing training on e-learning.It which takes 30 minutes will be done during 1month once a week. Psychoeducation about stress is done before training.
Interventions/Control_2
Job crafting training on e-learning.It which takes 30 minutes will be done during 1month once a week. Psychoeducation about stress is done before training.
Interventions/Control_3
None.But after this test,the intervention which is selected by each partcipants will be done.
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
| 34 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1:worker in irregular employment
2:young worker(from 18 to 34 years old)
Key exclusion criteria
(1) I have experienced training used for intervention.
(2) I was visiting a psychiatric department within the past month or had been counseling.
(3) I was diagnosed with depression within the past month.
(4) Have been diagnosed as having bipolar disorder in some cases.
(5) Within the past 3 months, I got a holiday totaling more than 15 days due to health problems.
Target sample size
153
Research contact person
Name of lead principal investigator
| 1st name | Kotaro |
| Middle name | |
| Last name | Taneichi |
Organization
Oberlin University
Division name
Graduate school of psychology
Zip code
1940294
Address
3578,Tokiwacho,Machida City,Tokyo,194-0294,Japan
TEL
042-797-0438
tane@obirin.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Kobayashi |
Organization
Oberlin University
Division name
Graduate school of psychology
Zip code
1940294
Address
3578,Tokiwacho,Machida City,Tokyo,194-0294,Japan
TEL
042-797-0438
Homepage URL
217j4006@s.obirin.ac.jp
Sponsor or person
Institute
Others
Ethics Committee of Oberlin university
Institute
Department
Personal name
Funding Source
Organization
others
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Oberlin University
Address
3578,Tokiwacho,Machida City,Tokyo,194-0294,Japan
Tel
042-797-6704
tane@obirin.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
| 2018 | Year | 12 | Month | 01 | 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
40
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Due to time consuming data analysis.
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2019 | 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
| 2018 | Year | 06 | Month | 27 | Day |
Last modified on
| 2023 | Year | 12 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037824
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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