UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046165 |
|---|---|
| Receipt number | 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 | 2022/05/31 10:46:19 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
stressmg.mhc@gmail.com
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
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
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
40
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
Completed
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
| 2022 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 11 | Month | 24 | Day |
Last modified on
| 2022 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052696
