UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054507 |
|---|---|
| Receipt number | R000062201 |
| Scientific Title | Research and Development of an Early Identification and Intervention Support System for High-Risk Groups with Gaming Behavior Disorder |
| Date of disclosure of the study information | 2024/06/01 |
| Last modified on | 2024/05/30 04:05:53 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Research and Development of an Early Identification and Intervention Support System for High-Risk Groups with Gaming Behavior Disorder
Acronym
Research and Development of an Early Identification and Intervention Support System for High-Risk Groups with Gaming Behavior Disorder
Scientific Title
Research and Development of an Early Identification and Intervention Support System for High-Risk Groups with Gaming Behavior Disorder
Scientific Title:Acronym
Research and Development of an Early Identification and Intervention Support System for High-Risk Groups with Gaming Behavior Disorder
Region
| Japan |
Condition
Condition
Gaming Disorder, Hazardous Game Use,Habit and Impulse Disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we aim to develop a medical device program for early identification and intervention support for high-risk groups of gaming behavior disorder that can be utilized outside of specialized medical institutions. Utilizing the SBIRTS mechanism used for substance dependence, which shares the same addiction mechanisms as gaming behavior disorder, we will: 1) identify high-risk groups through screening for gaming behavior disorder, and 2) provide early intervention support to promote behavior change through psychological care utilizing AI (feedback on results, advice, goal setting, etc.). The intervention aims to approach the indifferent group who are not aware of the danger early on and connect them to early treatment by reducing risk factors, gaming time, and problem behaviors. Gaming behavior disorder has been pointed out to correlate with social issues such as hikikomori (social withdrawal) and truancy (Kato et al., 2020), and it is expected to contribute to solving these social issues as well.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1)Adjust the screening accuracy to achieve a sensitivity of 90%, with the formula: (Number of people judged to be high-risk by the screening test) / (Total number of people diagnosed with "gaming behavior disorder" or "hazardous gaming" as per ICD-11 through a doctor's interview) = 0.9.
2)Measures: IAT, DASS-21, screentime.
3)Qualitative evaluation: Usability of the AI chatbot.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
1) Screening for game behavior disorders to identify high-risk groups, and 2) Early intervention support to promote behavior change through AI-based psychological care (feedback of results, advice, goal setting, etc.).
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
Eligibility
Age-lower limit
| 12 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Those who have experience in using games and the Internet.
Those who are at least 12 years old, junior high school student or older, and under 60 years old at the time of obtaining consent.
Those who have given written consent to participate in the study.
Key exclusion criteria
Those deemed ineligible by the implementer
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Nanase |
| Middle name | |
| Last name | Kobayashi |
Organization
Tokyo Medical and Dental University
Division name
Graduate SJoint Research Department of Cyberpsychiatrychool of Medical and Dental Sciences
Zip code
113-8510
Address
1-5-45,Bunkyo-ku,Yushima,Tokyo
TEL
03-3813-6111
nanase.psyc@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Nanase |
| Middle name | |
| Last name | Kobayashi |
Organization
Tokyo Medical and Dental University
Division name
Joint Research Department of Cyberpsychiatrychool , Graduate School of Medical and Dental Sciences
Zip code
113-8510
Address
1-5-45,Bunkyo-ku,Yushima,Tokyo
TEL
03-3813-6111
Homepage URL
nanase.psyc@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Faculty of Medicine, Tokyo Medical and Dental University
Address
1-5-45,Bunkyo-ku,Yushima,Tokyo
Tel
0338136111
info.bec@tmd.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
| 2024 | Year | 06 | Month | 01 | 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
| 2024 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | 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
| 2024 | Year | 05 | Month | 30 | Day |
Last modified on
| 2024 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062201
