UMIN-CTR Clinical Trial

Basic information
Public title	The effect of the stress coping skill training for young workers using iCBT
Acronym	The effect of the stress coping skill training for young workers using iCBT
Scientific Title	The effect of the stress coping skill training for young workers using iCBT
Scientific Title:Acronym	The effect of the stress coping skill training for young workers using iCBT
Region	Japan

Condition
Condition	healthy
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In one company, a training program based on iCBT will be implemented for young workers, and single case experiment will be analyzed to clarify changes in each index before and after the program. At the same time, the comparison after the intervention is made between participants and non-participants.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The pre-post change of the indicators for stress coping behavior
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Factorial
Randomization	Non-randomized
Randomization unit
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	internet-based Cognitive Behavior Therapy(iCBT)
Interventions/Control_2	normal service of employee assistance program
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	35 years-old >=
Gender	Male and Female
Key inclusion criteria	Young employees in the first and second years of joining a new graduate
Key exclusion criteria	None
Target sample size	20

Research contact person
Name of lead principal investigator	1st name SAE Middle name Last name NAKAGAWA
Organization	ADVANTAGE Risk Management Co., Ltd.
Division name	Research Department
Zip code	153-0051
Address	17F Nakameguro GT tower 2-1-1 Kamimeguro Meguro-ku, Tokyo, Japan
TEL	03-5794-3817
Email	snakagawa@armg.jp

Public contact
Name of contact person	1st name SAE Middle name Last name NAKAGAWA
Organization	ADVANTAGE Risk Management Co., Ltd.
Division name	Research Department
Zip code	153-0051
Address	17F Nakameguro GT tower 2-1-1 Kamimeguro Meguro-ku, Tokyo, Japan
TEL	03-5794-3817
Homepage URL
Email	snakagawa@armg.jp

Sponsor
Institute	ADVANTAGE Risk Management Co., Ltd.
Institute
Department

Funding Source
Organization	ADVANTAGE Risk Management Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	ADVANTAGE Risk Management Co., Ltd.
Address	17F Nakameguro GT tower 2-1-1 Kamimeguro Meguro-ku, Tokyo, Japan
Tel	03-5794-3817
Email	snakagawa@armg.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	2020 Year 01 Month 28 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	14
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	2020 Year 01 Month 10 Day
Date of IRB	2020 Year 01 Month 27 Day
Anticipated trial start date	2020 Year 01 Month 28 Day
Last follow-up date	2020 Year 12 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	2020 Year 01 Month 28 Day
Last modified on	2021 Year 07 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044596