UMIN-CTR Clinical Trial

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

gambling disorder

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

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

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

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

Institute

yosino hospital

Institute

Department

Personal name

Organization

segasammy holdings

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Ethics Comittee of Yoshino Hospital

Address

2252 zushimachi Machida-city Tokyo

Tel

042-791-0734

Email

ytejima@yushinohp.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2019

Year

07

Month

17

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

Registered date

2019

Year

07

Month

09

Day

Last modified on

2019

Year

07

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042415