UMIN-CTR Clinical Trial

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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052696