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 | 2025/02/10 09:43:48 |
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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
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
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
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
Completed
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
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 02 | Month | 07 | Day |
Last modified on
| 2025 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049387
