UMIN-CTR Clinical Trial

Basic information
Public title	Development, validity and reliability of gambling motivation scale Japanese version
Acronym	new gambling motivation scale
Scientific Title	Development, validity and reliability of gambling motivation scale Japanese version
Scientific Title:Acronym	new gambling motivation scale
Region	Japan

Condition
Condition	gambling disorder
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Development of a Japanese version of the Gambling Motivation (Desire) Scale, and evaluation of its reliability and validity Study 1: Investigation of the reliability and validity of the Japanese version of the modified Gambling Motivation Scale (MGMS) [8]. Study 2: Preparation of a new gambling motivation (desire) scale, based on the Japanese version of the MGMS (Japanese MGMS), and investigation of its reliability and validity.
Basic objectives2	Others
Basic objectives -Others	If a "desire-fulfilment method" or "lifestyle-support direction approach" , with motivation for gambling as the starting point, are used, there is a need for a comprehensive scale for evaluation of motivation. Several such scales have been developed in Europe and the USA, and research on their standardization is in progress in various countries [7], but their applicability in Japan has not been confirmed. In addition, with the scales in previous use, even if the structure of motivation can be evaluated, no consideration has been given to the consistency between the structure identified and the intervention method. Therefore, the importance of the clinical availability of a motivation scale remains unclear. The following two studies will be carried out as part of the resolution of the above issues.
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Comfirmative factor analysis by Structural Equation Modeling. RMSEA
Key secondary outcomes	Correlation between new scale and SOGS/PPAS TLI,CFI,SRMR,AIC,BIC

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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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	1. Subjects The subjects will be Internet-users recruited by a market research company. The administrative procedures relating to recruitment and selection of subjects will be optional and based on the ethical rules of the commissioned market research company. Data from the following two groups of subjects will be used: Study 1: Data used for verification of the Japanese MGMS with the English MGMS Number of subjects: 20 (10 males and 10 females) Inclusion criteria: (i) At least 20 years old and living in Greater Tokyo. (ii) Native Japanese-speakers. (iii) Experience of gambling at least once during the previous year. This includes any of the following: pachinko (a Japanese pinball-like game), slot machines, betting on horse-, bicycle- or boat-racing, and overseas casinos (unless online). Taking part in lotteries is not included. (iv) Bilingual in English, with TOEIC scores of at least 730. Study 2: Data for verification of the new gambling motivation scale with the Japanese MGMS Number of subjects: 150 Inclusion criteria: (i) At least 20 years old and living in Greater Tokyo. (ii) Native Japanese-speakers. (iii) Experience gambling at least once within the previous 6 months. This includes any of the following: pachinko, slot machines, betting on horse-, bicycle- or boat-racing, and overseas casinos (unless online).
Key exclusion criteria	reference above
Target sample size	170

Research contact person
Name of lead principal investigator	1st name yasunobu Middle name Last name komoto
Organization	yoshino hospital
Division name	psychiatry
Zip code	1940203
Address	2252 zushimachi Machida-city Tokyo
TEL	042-791-0734
Email	komoto@yoshinohp.com

Public contact
Name of contact person	1st name yasunobu Middle name Last name komoto
Organization	yoshino hospital
Division name	psychiatry
Zip code	1940203
Address	2252 zushimachi Machida-city Tokyo
TEL	042-791-0734
Homepage URL
Email	komoto@yoshinohp.com

Sponsor
Institute	yosino hospital
Institute
Department

Funding Source
Organization	segasammy holdings
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Ethics Comittee of Yoshino Hospital
Address	2252 zushimachi Machida-city Tokyo
Tel	042-791-0734
Email	ytejima@yushinohp.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	2019 Year 07 Month 17 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	Preinitiation
Date of protocol fixation	2019 Year 06 Month 17 Day
Date of IRB	2019 Year 06 Month 26 Day
Anticipated trial start date	2019 Year 08 Month 01 Day
Last follow-up date	2019 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Survey methods (a) Survey contents and procedures Study 1 The English MGMS (Document 1) and Japanese MGMS (Document 2) will each be allocated, using the Internet, to groups of 10 subjects (total: 20 subjects), these being the English-MGMS-first and Japanese-MGMS-first groups, respectively, and responses to each will be requested. Intervals of 3 to 7 days will be allowed between the survey dates with the English and Japanese MGMS. Study 2 The following three scales will be used: (i) the Japanese MGMS; (ii) the two-choice version of the Japanese MGMS, in which, for each question on the scale, the seven possible graded responses have been replaced with just "yes" or "no"; and (iii) the new gambling motivation scale (Document 3). In addition, in order to analyze the relationships of each motivation structure with severity and pathological level of ambivalence, the South Oaks Gambling Screen (SOGS.The subjects will be allocated to two groups, which will answer the surveys in different orders. One will answer the new gambling motivation scale, then the Japanese MGMS, and then the two-choice Japanese MGMS, whereas the other will answer the two-choice Japanese MGMS, then the Japanese MGMS, and then the new gambling motivation scale. Intervals of 3 to 7 days will be allowed between each survey. The fundamental background information about age, gambling frequency, etc., will be collected at the time of the first survey, whereas SOGS and PPAS will be completed at completion of the study, at the time of the third survey.

Management information
Registered date	2019 Year 07 Month 09 Day
Last modified on	2019 Year 07 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042415