UMIN-CTR Clinical Trial

Basic information
Public title	A randomized controlled trial of web-based brief intervention program (SNAPPY-DOC) for heavy drinkers
Acronym	A randomized controlled trial of web-based brief intervention program (SNAPPY-DOC) for heavy drinkers
Scientific Title	A randomized controlled trial of web-based brief intervention program (SNAPPY-DOC) for heavy drinkers
Scientific Title:Acronym	A randomized controlled trial of web-based brief intervention program (SNAPPY-DOC) for heavy drinkers
Region	Japan

Condition
Condition	Heavy drinkers
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of web-based brief intervention program (SNAPPY-DOC) for heavy drinkers
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Changes in the amount of alcohol consumption in the past 1 week measured with the TLFB method from pre- to post treatment(after 8 week, 12 week)
Key secondary outcomes	Change in AUDIT total score from pre- to post treatment (after 12 week) Presence / absence of wish to reduce drinking amount, experience receiving guidance to reduce drinking amount, self-confidence to save alcohol, changes in life caused by alcohol and changes in the amount of alcohol consumption in the past 1 week measured with the TLFB method from pre- to post treatment (after 12 week) Percentage of included potential participants who satisfy eligibility criteria Subsequent dropout rate, program completion rate

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	Recording daily alcohol consumption for a month using the web-based brief intervention program (SNAPPY-DOC)
Interventions/Control_2	Assessment only
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Participants aged 20 years or older who are on duty or undergoing a medical examination at a work area or medical institution which have consented to cooperate on the trial Participants who can periodically connect to the Internet and can send and receive e-mail Participants whose AUDIT score is more than or equal to 8
Key exclusion criteria	Those who have been judged by the research director that they are not suitable for participating in the research
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Takefumi Middle name Last name Ueno
Organization	National Hospital Organization Hizen Psychiatric Center
Division name	Clinical Research Department
Zip code	842-0192
Address	Mitsu 160 Yoshinagari-cho Kanzaki-gun Saga prefecture 842-0192
TEL	0952-52-3231
Email	uenotk@gmail.com

Public contact
Name of contact person	1st name Takashi Middle name Last name Sunami
Organization	Local incorporated administrative agency Saga-Ken Medical Centre Koseikan
Division name	Psychiatry
Zip code	840-8571
Address	400 Nakabaru, Kase-machi, Saga-shi, 840-8571
TEL	0952-24-2171
Homepage URL
Email	takashisunami2010@gmail.com

Sponsor
Institute	National Hospital Organization Hizen Psychiatric Center
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Government offices of other countries
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Local incorporated administrative agency Saga-Ken Medical Centre Koseikan Institutional Review Board
Address	400 Nakabaru, Kase-machi, Saga-shi, 840-8571
Tel	0952-24-2171
Email	rinrishinsa@koseikan.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	非公開

Other administrative information
Date of disclosure of the study information	2019 Year 08 Month 21 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://onlinelibrary.wiley.com/doi/10.1002/1348-9585.12312
Number of participants that the trial has enrolled	100
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	Main results already published
Date of protocol fixation	2019 Year 03 Month 07 Day
Date of IRB	2019 Year 07 Month 12 Day
Anticipated trial start date	2019 Year 08 Month 21 Day
Last follow-up date	2021 Year 03 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	2019 Year 08 Month 16 Day
Last modified on	2022 Year 02 Month 16 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042703