UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023151 |
|---|---|
| Receipt number | 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 | 2023/10/11 13:02:36 |
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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
Department of Digital Mental Health
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-5800-9621
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
Department of Digital Mental Health
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-5800-9621
Homepage URL
asuka-tky@umin.ac.jp
Sponsor or person
Institute
Department of Digital Mental Health, Graduate School of Medicine, The University of Tokyo
Institute
Department
Personal name
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
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
Not Applicable
Publication of results
Published
Result
URL related to results and publications
Not Applicable
Number of participants that the trial has enrolled
665
Results
The differnce between each program was significant (F=2.46, df=6, p=0.024). Especially, behavioral activation (d=-0.62) and providing knowledge about stress (d=-0.47) showed moderate effects. On the other hand, the effects of cognitive restruction, poroblem-solution techniques, assertiveness, physical activity, and job crafting were small (d=-0.29~0.01).
Results date posted
| 2023 | Year | 10 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Most participants were male, and regular employees.
Participant flow
A total of 755 employees in the service industry were invited to participate. Of these, 665 (88%) who agreed to participate and responded to the baseline survey were randomly assigned to one of seven groups.
Adverse events
Not Applicable
Outcome measures
Psychological distress (Brief job stress questionnaire)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2023 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026683
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| Registered date | File name |
| Research case data | |
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