UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040003 |
|---|---|
| Receipt number | 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 | 2025/02/10 09:46:00 |
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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
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
k-yoko@fc.ritsumei.ac.jp
Sponsor or person
Institute
Okayama Psychiatric Medical center
Institute
Department
Personal name
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
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
https://doi.org/10.1007/s10899-024-10364-w
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1007/s10899-024-10364-w
Number of participants that the trial has enrolled
274
Results
With data from 274 participants (GAMCHECK: n = 141; AO: n = 133), we demonstrated that GAMCHECK was more effective solely on GRCS than AO at both one-week and four-week follow-up. Furthermore, by the 12-week follow-up, GAMCHECK significantly more effective than AO on gambling symptoms measured by the GSAS, number of gambling days and amount of money spent on gambling during the prior week, GRCS, and PGI-C at 12-week follow-up. No significant effects were found for help-seeking behaviors.
Results date posted
| 2025 | Year | 02 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 12 | Month | 31 | Day |
Baseline Characteristics
Of the 274 participants, 54.46% (n = 141, mean age = 45.50 years, SD = 9.66) and 48.54% (n = 133, mean age = 45.33 years, SD = 9.61) were assigned to GAMCHECK and AO groups, respectively. Of the 141 participants allocated to the GAMCHECK group, 13 were non-responsive at the 12-week follow-up, as were 10 of the 133 participants in the AO group. Participants were recruited from online survey panels owned by a survey company in Japan (Cross Marketing, Inc.) between November 11 and 15, 2020.
Participant flow
In total, 274 participants (male = 228, female = 45, other = 1, mean age = 45.42 years, SD = 9.62) were recruited for this online study. Of the 1,681 individuals who indicated on the screening questionnaire that they would like to participate in this study, 927 met the inclusion criteria. Of these, 620 were randomly selected to receive an e-mail requesting participation, 274 of which responded to the e-mail and thus participated in this study.
Adverse events
In this study, potential harms were evaluated exclusively through measurements, with no other methods employed.
Outcome measures
there was a significant interaction between group and time for the number of days participants gambled during the prior week (t (717.1831) = 2.125, p < .05) and for the amount of money they had spent on gambling at 12-week follow-up (t (710.31638) = 2.188, p < .05).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
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
| 2024 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 03 | Month | 31 | 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=R000045603
