UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040071 |
|---|---|
| Receipt number | R000043803 |
| Scientific Title | Effect of web-based self-complexity program for young workers |
| Date of disclosure of the study information | 2020/04/06 |
| Last modified on | 2020/04/06 16:09:01 |
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Basic information
Public title
Effect of web-based self-complexity program for young workers
Acronym
Effect of web-based self-complexity program for young workers
Scientific Title
Effect of web-based self-complexity program for young workers
Scientific Title:Acronym
Effect of web-based self-complexity program for young workers
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To exam the effect of web-based self-complexity program for young workers.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Trait sorting task, The Center for Epidemiologic Studies Depression Scale, Work engagement scale, Stanford Presenteeism Scale
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
psycho educational program (5 times, once per week)
Interventions/Control_2
Take the program after the research
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
| 29 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Currently not undergoing treatment / hospitalization / medicine treatment due to psychiatric symptoms
2) Currently not taking leave or retirement
3) 20 years old or older and less than 30 years old
Key exclusion criteria
1) Currently undergoing treatment / hospitalization / medicine treatment due to psychiatric symptoms
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Junko |
| Middle name | |
| Last name | Kawahito |
Organization
Kagawa university
Division name
School of Medicine
Zip code
761-0793
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa Prefecture, Japan
TEL
087-891-5662
j-kawahito@med.kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Junko |
| Middle name | |
| Last name | Kawahito |
Organization
Kagawa university
Division name
School of Medicine
Zip code
761-0793
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa Prefecture, Japan
TEL
087-891-5662
Homepage URL
j-kawahito@med.kagawa-u.ac.jp
Sponsor or person
Institute
Kagawa university
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kagawa university
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa Prefecture, Japan
Tel
0878915662
j-kawahito@med.kagawa-u.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
| 2020 | Year | 04 | Month | 06 | 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
44
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 12 | Month | 01 | Day |
Baseline Characteristics
Participant flow
Adverse events
Not applicable
Outcome measures
Trait sorting task, The Center for Epidemiologic Studies Depression Scale, Utrecht Work Engagement Scale, Japanese Stanford Presenteeism Scale, sex, age
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 17 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 11 | Day |
Last follow-up date
| 2020 | Year | 01 | 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
| 2020 | Year | 04 | Month | 06 | Day |
Last modified on
| 2020 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043803
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
