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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031836
Receipt No. R000036323
Scientific Title Messaging App intervention for gambling problems: a randomized controlled trial
Date of disclosure of the study information 2018/03/23
Last modified on 2020/10/12

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Basic information
Public title Messaging App intervention for gambling problems: a randomized controlled trial
Acronym Messaging App intervention for gambling problems: a randomized controlled trial
Scientific Title Messaging App intervention for gambling problems: a randomized controlled trial
Scientific Title:Acronym Messaging App intervention for gambling problems: a randomized controlled trial
Region
Japan

Condition
Condition Problem gambling (We will include gamblers who do not satisfy the diagnostic criteria of DSM-5 for gambling disorder)
Classification by specialty
Psychiatry Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of the message app delivered intervention for problem gambling
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II,III

Assessment
Primary outcomes Change in PGSI total score from pre- to post-treatment (day 28)
Key secondary outcomes ・GSAS (Gambling Symptom Assessment Scale)
Change through the study period (pre-treatment, day7, 14, 21, 28)
・Amount of money spent on gambling
Change from pre- to post-treatment (day 28)
・Gambling frequency
Change from pre- to post-treatment (day 28)
・Drop-out rate

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Device,equipment Behavior,custom
Interventions/Control_1 MFS (Monitoring, Feedback, Supportive message)
Personalized Normative Feedback (Message App delivered) for 28 days
Interventions/Control_2 AO (Assessment Only) (Message App delivered) through 28 days
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1) Inclusion criteria
1. Aged 18 years old or older who uses LINE app
2. Who provides informed consent
3. PGSI (Problem Gambling Severity Index) score of 3 or above at pre-treatment
Key exclusion criteria (2) Exclusion criteria
1. Who has taken some treatment for their gambling problems at specialized facilities
Target sample size 198

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Susumu Higuchi
Organization Kurihama Medical and Addiction Center
Division name Department of Clinical Research
Zip code
Address Nobi 5-3-1, Yokosuka, Kanagawa Prefecture, Japan
TEL 046-848-1550
Email gambotamed@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Susumu Higuchi
Organization Kurihama Medical and Addiction Center
Division name Department of Clinical Research
Zip code
Address Nobi 5-3-1, Yokosuka, Kanagawa Prefecture, Japan
TEL 046-848-1550
Homepage URL http://hachidori.io/hdupload/gambot/index.html
Email gambotamed@gmail.com

Sponsor
Institute Kurihama Medical and Addiction Center
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 03 Month 23 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
2018 Year 03 Month 16 Day
Date of IRB
2018 Year 03 Month 23 Day
Anticipated trial start date
2018 Year 03 Month 26 Day
Last follow-up date
2018 Year 08 Month 31 Day
Date of closure to data entry
2018 Year 09 Month 23 Day
Date trial data considered complete
2018 Year 09 Month 23 Day
Date analysis concluded
2019 Year 04 Month 04 Day

Other
Other related information

Management information
Registered date
2018 Year 03 Month 22 Day
Last modified on
2020 Year 10 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036323

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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