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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033631
Receipt No. R000038295
Official scientific title of the study Effects of Cognitive Behavioral Self-monitoring app on Reducing Problem Drinking among Japanese Adults
Date of disclosure of the study information 2018/08/06
Last modified on 2018/08/01

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Basic information
Official scientific title of the study Effects of Cognitive Behavioral Self-monitoring app on Reducing Problem Drinking among Japanese Adults
Title of the study (Brief title) Effects of Self-monitoring App on Problem Drinking
Region
Japan

Condition
Condition Alcohol use disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of this study is to reduce excessive drinking, depression and anxiety by using in a self-monitoring app for one month.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Drinking quantity
Drinking frequency
Key secondary outcomes Depression
Anxiety
Self-monitoring tendency

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Assessment only
Interventions/Control_2 App use only
Interventions/Control_3 App use plus professional's feedback
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
65 years-old >=
Gender Male and Female
Key inclusion criteria AUDIT score of 8 or higher
Key exclusion criteria AUDIT score 7 or lower
Target sample size 200

Research contact person
Name of lead principal investigator Haruhiko Shimoyama
Organization Graduate School of Education, the University of Tokyo
Division name Division of Clinical Psychology
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL 81-3-5841-3904
Email h3954s@p.u-tokyo.ac.jp

Public contact
Name of contact person Toshitaka Hamamura
Organization Graduate School of Education, the University of Tokyo
Division name Division of Clinical Psychology
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL 81-3-5841-3904
Homepage URL
Email hamamura@g.ecc.u-tokyo.ac.jp

Sponsor
Institute Graduate School of Education, the University of Tokyo
Institute
Department

Funding Source
Organization Social ICT Global Creative Leader Program, the University of Tokyo
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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

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
2018 Year 08 Month 06 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 08 Month 06 Day
Anticipated trial start date
2018 Year 08 Month 06 Day
Last follow-up date
2019 Year 08 Month 06 Day
Date of closure to data entry
2019 Year 08 Month 06 Day
Date trial data considered complete
2019 Year 08 Month 06 Day
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 08 Month 03 Day
Last modified on
2018 Year 08 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038295

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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