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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000040071
Receipt No. 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

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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
Email 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
Email j-kawahito@med.kagawa-u.ac.jp

Sponsor
Institute Kagawa university
Institute
Department

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
Email 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
URL(English) https://upload.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
Registered date File name


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