UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043270
Receipt number R000049387
Scientific Title A randomized controlled trial of smartphone application for reducing gambling symptoms (Gamble Control) for Japanese high-risk gamblers
Date of disclosure of the study information 2021/02/09
Last modified on 2023/08/11 09:38:06

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Basic information

Public title

A randomized controlled trial of smartphone application for reducing gambling symptoms (Gamble Control) for Japanese high-risk gamblers

Acronym

A randomized controlled trial of smartphone application for reducing gambling symptoms (Gamble Control) for Japanese high-risk gamblers

Scientific Title

A randomized controlled trial of smartphone application for reducing gambling symptoms (Gamble Control) for Japanese high-risk gamblers

Scientific Title:Acronym

A randomized controlled trial of smartphone application for reducing gambling symptoms (Gamble Control) for Japanese high-risk gamblers

Region

Japan


Condition

Condition

High-risk gamblers

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 smartphone application (Gamble Control) for reducing gambling symptoms among high-risk gamblers.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

gambling symptom (measured by Gambling Symptom Assessment Scale)

Key secondary outcomes

Gabling behaviors (gambling days, amount of money)
Gambling cognitive distortion (measured by Gambling Related Cognitions Scale)
Other (perceived helpfulness, satisfaction with use, the depth of understanding)


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are 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

3

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Smartphone application (Gamble Control)

Interventions/Control_2

Assessment only

Interventions/Control_3

Smartphone application (Gamble Control)+ counselling

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

69 years-old >=

Gender

Male and Female

Key inclusion criteria

Gambling symptoms are over mild (3 <= PGSI)
Gives full informed consent to participate in the study

Key exclusion criteria

Those who participated in a gambling disorder treatment or gambling reduction support program or self-help group in the four weeks prior to screening
Those who had received other structured psychotherapy in the four weeks prior to screening
Those who do routinely use a smartphone installed with android
Those who has been judged to be not suitable for the subject of this this study by the principal investigator

Target sample size

174


Research contact person

Name of lead principal investigator

1st name Kengo
Middle name
Last name Yokomitsu

Organization

University of Human Environments

Division name

School of Psychological SciencesSchool of Psychological Sciences

Zip code

7900825

Address

9-12, dogohimata, Matsuyama, Ehime 7900825, Japan

TEL

072-665-2490

Email

yokomitsuken5@gmail.com


Public contact

Name of contact person

1st name Kengo
Middle name
Last name Yokomitsu

Organization

University of Human Environments

Division name

School of Psychological Sciences

Zip code

7900825

Address

9-12, dogohimata, Matsuyama, Ehime 7900825, Japan

TEL

08066417784

Homepage URL


Email

yokomitsuken5@gmail.com


Sponsor or person

Institute

University of Human Environments

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the promotion of science

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor

Fukui University

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ritsumeikan University

Address

2-150, Iwakura-cho, Ibaraki, Osaka 560-8570, Japan

Tel

077-561-3412

Email

b-rinri@st.ritsumei.ac.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



Other administrative information

Date of disclosure of the study information

2021 Year 02 Month 09 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

No longer recruiting

Date of protocol fixation

2021 Year 02 Month 07 Day

Date of IRB

2020 Year 03 Month 11 Day

Anticipated trial start date

2023 Year 01 Month 06 Day

Last follow-up date

2023 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

2021 Year 02 Month 07 Day

Last modified on

2023 Year 08 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049387


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name