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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000040003
Receipt No. R000045603
Scientific Title The effectiveness of the personalized normative feedback for Japanese gamblers students: Randomized controlled trial
Date of disclosure of the study information 2020/03/31
Last modified on 2021/06/28

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Basic information
Public title The effectiveness of the personalized normative feedback for Japanese gamblers students: Randomized controlled trial
Acronym The effectiveness of the personalized normative feedback for Japanese gamblers students: Randomized controlled trial
Scientific Title The effectiveness of the personalized normative feedback for Japanese gamblers students: Randomized controlled trial
Scientific Title:Acronym The effectiveness of the personalized normative feedback for Japanese gamblers students: Randomized controlled trial
Region
Japan

Condition
Condition gambling disorder
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to test the effectiveness of personalized normative feedback for gamble symptoms among Japanese gamblers
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Gambling symptoms measured by the Japanese version of the Gambling Symptom Assessment Scale
Key secondary outcomes Gambling behaviors (frequency, amount of money)
Gambling distortion measured by Japanese version of Gambling Related Cognitions Scale
Dropout ratio
Treatment seeking behaviors
Active treatment use
Net promoter score

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 Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Personalized Normative Feedback
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 3 <= Japanese version of the Problem Gambling Severity Index
Gives full informed consent to participate in the study
Key exclusion criteria Experience using the Gambling professional tretament
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Ryuhei
Middle name
Last name So
Organization Okayama Psychiatric Medical center
Division name Department of Psychiatry
Zip code 7000915
Address 3-16, Shikatahonmachi, kita-ku,Okayama
TEL 086-225-3821
Email nexttext@gmail.com

Public contact
Name of contact person
1st name Kengo
Middle name Yokomitsu
Last name Yokomitsu
Organization Ritsumeikan University
Division name College of Comprehensive Psychology
Zip code 5678570
Address 2-150, Iwakura-cho, Ibaraki, Osaka
TEL 072-665-2490
Homepage URL
Email k-yoko@fc.ritsumei.ac.jp

Sponsor
Institute Okayama Psychiatric Medical center
Institute
Department

Funding Source
Organization Health and Labor Sciences Research Grants
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 Okayama Psychiatric Medical center
Address 3-16, Shikatahonmachi, kita-ku,Okayama
Tel 086-225-3821
Email nexttext@gmail.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

Other administrative information
Date of disclosure of the study information
2020 Year 03 Month 31 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
2020 Year 03 Month 10 Day
Date of IRB
2020 Year 03 Month 02 Day
Anticipated trial start date
2020 Year 03 Month 31 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
2021 Year 03 Month 31 Day
Date trial data considered complete
2021 Year 06 Month 28 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 03 Month 31 Day
Last modified on
2021 Year 06 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045603

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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