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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000046165
Receipt No. R000052696
Scientific Title Effectiveness of stress management education intervention for high-stress individuals caused by home/remote work
Date of disclosure of the study information 2021/11/24
Last modified on 2021/11/24

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Basic information
Public title Effectiveness of stress management education intervention for high-stress individuals caused by home/remote work
Acronym Effectiveness of stress management education intervention for high stress due to home/remote work
Scientific Title Effectiveness of stress management education intervention for high-stress individuals caused by home/remote work
Scientific Title:Acronym Effectiveness of stress management education intervention for high stress due to home/remote work
Region
Japan

Condition
Condition Nothing
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In recent years, with the decrease in simple and excessive work due to the introduction of large amounts of information and machines due to modernization and the increase in the number of companies implementing telecommuting and remote work due to the epidemic of the new coronavirus infection since March 2020, a new stress load has arisen and people with mental health problems have emerged. In order to cope with this disorder, we are developing a "stress management pamphlet" and other tools aimed at helping people to recognize their own high-stress conditions and to check and manage their stress.
In this study, we will actually examine the effects on stress and the usefulness of the information by viewing the pamphlets and videos developed by the research group and through psycho-educational interventions.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes No-hirou Scale
Key secondary outcomes Changes in stress management behaviors, degree of work performance, QIDS-J, characterization, and Impact of remote work, Stomane pamphlet evaluation

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is 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
Behavior,custom
Interventions/Control_1 A intervention of Psychoeducation about stress management ,online indivisual format, 30 min per session. Custom-made pamphlets or videos of stress management videos (10 themes in total).
Interventions/Control_2 Control group
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
70 years-old >=
Gender Male and Female
Key inclusion criteria Fulfilling all of the following inclusion criteria:
1 >=20 yo <=70 yo
2 After COVIT-19 expansion, switching to home/remote work at least 3 days a week.
3 >=21 score of No-hirou Scale at baseline
4 Have internet access to participate in online format program
5 Voluntary participation and comprehension of the purpose or risks of this study
Key exclusion criteria Either:
1) Visit a psychiatrist for treatment of psychiatric disorders such as depression, schizophrenia, bipolar disorder, and dementia.
2) This study's researchers or their family members
3) Individuals whom researchers judge to inappropriate to participate in this study
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Kei
Middle name
Last name Hirai
Organization Osaka University
Division name Graduate School of human sciences
Zip code 565-0871
Address 1-2 Yamadaoka Suita-city, Osaka
TEL 0668798124
Email stressmg.mhc@gmail.com

Public contact
Name of contact person
1st name Kei
Middle name
Last name Hirai
Organization Osaka University
Division name Graduate School of human sciences
Zip code 5650871
Address 1-2 Yamadaoka Suita-city, Osaka
TEL 0668798124
Homepage URL
Email stressmg.mhc@gmail.com

Sponsor
Institute Osaka University
Institute
Department

Funding Source
Organization Japan Sciences and Technology Agency
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Osaka University Graduate School of human sciences Education
Address 1-2 Yamadaoka Suita-city, Osaka
Tel 0668798124
Email khirai@hus.osaka-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
2021 Year 11 Month 24 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 Enrolling by invitation
Date of protocol fixation
2021 Year 11 Month 01 Day
Date of IRB
2021 Year 09 Month 16 Day
Anticipated trial start date
2021 Year 11 Month 24 Day
Last follow-up date
2022 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 11 Month 24 Day
Last modified on
2021 Year 11 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052696

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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