UMIN-CTR Clinical Trial

Basic information
Public title	Development and a pilot trial of an internet-based educational program for reducing heavy drinking
Acronym	Development and pilot trial of an ICT program for reducing heavy drinking
Scientific Title	Development and a pilot trial of an internet-based educational program for reducing heavy drinking
Scientific Title:Acronym	Development and pilot trial of an ICT program for reducing heavy drinking
Region	Japan

Condition
Condition	Alcohol use disorder
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To develop and examine effectiveness of an internet-based personalized normative feedback intervention on alcohol-related problems
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Alcohol consumption
Key secondary outcomes	AUDIT-C

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are 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	2
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	Personalized normative feedback
Interventions/Control_2	Psychoeducation on alcohol-related problems
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	65 years-old >=
Gender	Male and Female
Key inclusion criteria	AUDIT score of 8 or higher Age between 20 and 65
Key exclusion criteria	AUDIT score of 7 or lower Age lower than 20 and higher than 66
Target sample size	600

Research contact person
Name of lead principal investigator	1st name Haruhiko Middle name Last name Shimoyama
Organization	Graduate School of Education, the University of Tokyo
Division name	Division of Clinical Psychology
Zip code	113-0033
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL	81-3-5841-3949
Email	h3954s@p.u-tokyo.ac.jp

Public contact
Name of contact person	1st name Toshitaka Middle name Last name Hamamura
Organization	Graduate School of Education, the University of Tokyo
Division name	Division of Clinical Psychology
Zip code	113-0033
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL	81-3-5841-3904
Homepage URL
Email	toshitaka.hamamura@gmail.com

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 Grant-in-Aid for JSPS fellows (17J03078), Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Life Science Research Ethics and Safety
Address	7-3-1 Hongo Bunkyo-ku, Tokyo
Tel	81-3-5841-0643
Email	lifescience.adm@gs.mail.u-tokyo.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	2017 Year 12 Month 25 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	Completed
Date of protocol fixation	2017 Year 12 Month 25 Day
Date of IRB	2017 Year 11 Month 05 Day
Anticipated trial start date	2018 Year 01 Month 01 Day
Last follow-up date	2018 Year 05 Month 31 Day
Date of closure to data entry	2018 Year 08 Month 31 Day
Date trial data considered complete
Date analysis concluded	2020 Year 07 Month 31 Day

Other
Other related information

Management information
Registered date	2017 Year 12 Month 14 Day
Last modified on	2021 Year 06 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034388