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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000047621
Receipt No. R000054294
Scientific Title Study on application of smartphone cognitive behavioral therapy to promote mental health and well-being in the workplace
Date of disclosure of the study information 2022/05/06
Last modified on 2022/04/30

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Basic information
Public title Study on application of smartphone cognitive behavioral therapy to promote mental health and well-being in the workplace
Acronym Study on application of smartphone cognitive behavioral therapy to promote mental health and well-being in the workplace
Scientific Title Study on application of smartphone cognitive behavioral therapy to promote mental health and well-being in the workplace
Scientific Title:Acronym Study on application of smartphone cognitive behavioral therapy to promote mental health and well-being in the workplace
Region
Japan

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

Objectives
Narrative objectives1 A smartphone cognitive-behavioral therapy app aimed at improving the mental health and well-being of working adults and a chatbot that encourages continued use of that app will be randomly assigned to two groups depending on the presence or absence of a chatbot for 150 Sony employees. Then, check the effect of the message by the chatbot.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The primary endpoint is the completion of the smartphone cognitive-behavioral therapy app, which calculates the percentage of participants who completed the problem-solving component within 8 weeks (56 days) from the day they started using the app.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Have all participants use the smartphone cognitive behavioral therapy app. The app consists of five components(self-monitoring, cognitive reconstruction, behavioral activation, assertion, problem-solving), with participants working on lessons in turn at a pace of one component per week.
Interventions/Control_2 In addition to the above interventions, Chatbots that encourage continued use of the smartphone cognitive-behavioral therapy app are randomly assigned to two groups, with and without chatbots. Chatbot users are sent daily, morning and night with messages that encourage them to use the app.
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
60 years-old >=
Gender Male and Female
Key inclusion criteria 1) Full-time employee of Sony Group Corporation or Sony Corporation
2) Living in Japan
3) Men and women between the ages of 20 and 60
4)They must have their own smartphone, either an Apple iPhone or Android device
5)They must provide electromagnetic or written informed consent to participate in this study
6)They must agree to use the smartphone cognitive behavioral therapy app
7)They must agree to the license and use of wearable device and messaging application.
Key exclusion criteria 1)Being unable to read or write Japanese sentences
2)Receiving professional treatment for mental health problems
3)PHQ-9 score of the pre-assessment meets the following two points
i)15 points or more
ii)10 points or more and 9th item (suicidal ideation item) is 2 or 3
4)Expected to retire during the participation period (retirement age or job change has been decided)

Target sample size 150

Research contact person
Name of lead principal investigator
1st name Takuya
Middle name
Last name Kishimoto
Organization Sony Group Corporation
Division name R&D Center Tokyo Laboratory 11
Zip code 113-8510
Address Sony Open Lab., Tokyo Medical and Dental University M&D Tower 20F ,1-5-45 Yushima Bunkyo-ku, Tokyo, Japan
TEL 070-7598-7140
Email Takuya.Kishimoto@sony.com

Public contact
Name of contact person
1st name Takuya
Middle name
Last name Kishimoto
Organization Sony Group Corporation
Division name R&D Center Tokyo Laboratory 11
Zip code 113-8510
Address Tokyo Medical and Dental University M&D Tower 20F ,1-5-45 Yushima Bunkyo-ku, Tokyo, Japan
TEL 070-7598-7140
Homepage URL
Email sgc-rdc-tl11-dh-epoc-office@sony.com

Sponsor
Institute Sony Group Corporation
Institute
Department

Funding Source
Organization Sony Group Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization None

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

IRB Contact (For public release)
Organization Sony Bioethics Committee
Address 1-7-1 Kounan, Minato-ku, TOKYO, JAPAN
Tel 03-6748-2111
Email info-s-rec@sony.com

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 ソニーグループ株式会社 R&Dセンター Tokyo Laboratory 11

Other administrative information
Date of disclosure of the study information
2022 Year 05 Month 06 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
2022 Year 03 Month 18 Day
Date of IRB
2022 Year 03 Month 18 Day
Anticipated trial start date
2022 Year 05 Month 09 Day
Last follow-up date
2022 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2025 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2022 Year 04 Month 28 Day
Last modified on
2022 Year 04 Month 30 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054294

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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