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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000023151
Receipt No. R000026683
Scientific Title Effects of e-learning stress management programs on psychological distress and work engagement among workers: a randomized controlled trial
Date of disclosure of the study information 2016/07/14
Last modified on 2019/07/16

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Basic information
Public title Effects of e-learning stress management programs on psychological distress and work engagement among workers: a randomized controlled trial
Acronym Effects of e-learning stress management programs on psychological distress and work engagement among workers: a randomized controlled trial
Scientific Title Effects of e-learning stress management programs on psychological distress and work engagement among workers: a randomized controlled trial
Scientific Title:Acronym Effects of e-learning stress management programs on psychological distress and work engagement among workers: a randomized controlled trial
Region
Japan

Condition
Condition None
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of the study is to examine the effectiveness of e-learning stress management programs on improving psychological distress and work engagement among workers in a seven-arm randomized controlled trial.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1) Psychological distress measured by a relevant scale of the Brief Job Stress Questionnaire
2) Work engagement measured by Utrecht Work Engagement Scale (UWES)
Key secondary outcomes Completion of program(s)
Satisfaction with the e-learning program(s)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 7
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 e-learning stress management program about behavioral activation in about ten minutes
Interventions/Control_2 e-learning stress management program about cognitive reconstruction in about ten minutes
Interventions/Control_3 e-learning stress management program about problem-solution techniques in about ten minutes
Interventions/Control_4 e-learning stress management program about assertiveness in about ten minutes
Interventions/Control_5 e-learning stress management program about physical activity in about ten minutes
Interventions/Control_6 e-learning stress management program about job crafting in about ten minutes
Interventions/Control_7 for control, e-learning program which provides knowledge about stress in about ten minutes
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Employees
Key exclusion criteria None
Target sample size 470

Research contact person
Name of lead principal investigator
1st name Norito
Middle name
Last name Kawakami
Organization Graduate School of Medicine, University of Tokyo
Division name Mental health
Zip code 1130033
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL 03-5841-3521
Email norito@m.u-tokyo.ac.jp

Public contact
Name of contact person
1st name Asuka
Middle name
Last name Sakuraya
Organization Graduate School of Medicine, University of Tokyo
Division name Mental health
Zip code 1130033
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL 03-5841-3364
Homepage URL
Email asuka-tky@umin.ac.jp

Sponsor
Institute Department of Mental Health, Graduate School of Medicine, University of Tokyo
Institute
Department

Funding Source
Organization Infocom Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Research ethics committee, Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
Tel 03-5841-0818
Email 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
2016 Year 07 Month 14 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 No longer recruiting
Date of protocol fixation
2016 Year 07 Month 14 Day
Date of IRB
2016 Year 06 Month 09 Day
Anticipated trial start date
2016 Year 07 Month 14 Day
Last follow-up date
2017 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
2016 Year 07 Month 13 Day
Last modified on
2019 Year 07 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026683

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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