UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000055209 |
|---|---|
| Receipt number | R000063085 |
| Scientific Title | Assessing the Effects of Integrated Mindfulness and Cognitive Behavioral Therapy on Internet Gaming Disorder among Chinese College Students: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2024/08/09 |
| Last modified on | 2026/08/04 16:02:30 |
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Basic information
Public title
Assessing the Effects of Integrated Mindfulness and Cognitive Behavioral Therapy on Internet Gaming Disorder among Chinese College Students: A Randomized Controlled Trial
Acronym
Assessing the Effects of Integrated Mindfulness and Cognitive Behavioral Therapy on Internet Gaming Disorder among Chinese College Students
Scientific Title
Assessing the Effects of Integrated Mindfulness and Cognitive Behavioral Therapy on Internet Gaming Disorder among Chinese College Students: A Randomized Controlled Trial
Scientific Title:Acronym
Assessing the Effects of Integrated Mindfulness and Cognitive Behavioral Therapy on Internet Gaming Disorder among Chinese College Students
Region
| Asia(except Japan) |
Condition
Condition
Internet Gaming Disorder
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the prevalence of Internet Gaming Disorder (IGD) among Chinese university students and to explore various underlying factors such as gaming motivations and psychological factors. The aim is to facilitate the early detection and prevention of IGD in university students. Additionally, the study seeks to develop effective intervention programs and create a treatment manual that can be used by other therapists to promote the adaptation of university students to real-life situations.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Severity of Internet Gaming Disorder
Key secondary outcomes
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
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
A structured five-session intervention program based on cognitive-behavioral therapy
Interventions/Control_2
No treatment control1
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
| 35 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Participants who meet the cutoff score of 20 or above on the Internet Gaming Disorder Scale.
Ability to understand the purpose of the study and provide informed consent for participation.
Key exclusion criteria
University students who are receiving treatment for mental disorders.
University students with severe cognitive impairments and physiological diseases.
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Nobuaki |
| Middle name | N/A |
| Last name | Morita |
Organization
Tsukuba University
Division name
Department of Social Psychiatry and Mental Health,
Zip code
305-0006
Address
1-1-1 Tennodai, Tsukuba City, Ibaraki Prefecture, Japan Tsukuba University Comprehensive Research Building D743
TEL
81-29-853-3099
nobumori@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Ruoyu |
| Middle name | |
| Last name | Zhou |
Organization
Tsukuba University
Division name
Doctoral Program in Human Care Science, Graduate School of Comprehensive Human Sciences
Zip code
305-0006
Address
1-1-1 Tennodai, Tsukuba City, Tsukuba University, Comprehensive Research Building, Room D743
TEL
08064248612
Homepage URL
zhouruoyu86@gmail.com
Sponsor or person
Institute
Tsukuba University
Institute
Department
Personal name
Ruoyu zhou
Funding Source
Organization
Tsukuba University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tsukuba University
Address
1-1-1 Tennodai, Tsukuba City, Tsukuba University, Comprehensive Research Building, Room D743
Tel
08064248612
zhouruoyu86@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
| 2024 | Year | 08 | Month | 09 | Day |
Related information
URL releasing protocol
https://hdl.handle.net/2241/0002017410
Publication of results
Partially published
Result
URL related to results and publications
https://hdl.handle.net/2241/0002017410
Number of participants that the trial has enrolled
63
Results
Analyses included 44 completers (intervention, n=21; control, n=23). A significant group-by-time interaction was observed for IGD symptoms. The between-group difference in change favored the intervention immediately after treatment, whereas no significant between-group difference was found at the one-month follow-up. No clear group-by-time interactions were observed for the other psychological or motivational outcomes.
Results date posted
| 2026 | Year | 08 | Month | 04 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
The trial results were included in a doctoral dissertation and made publicly available through the university institutional repository. Posting the results in UMIN-CTR was delayed because additional analyses, manuscript preparation and revision, and journal submission required more time than expected. The delay was not related to concerns about the study findings or participant safety.
Date of the first journal publication of results
Baseline Characteristics
The primary analysis included 44 participants: 21 in the intervention group and 23 in the control group. Mean age was 19.66 years (SD=0.73) in the intervention group and 19.65 years (SD=1.23) in the control group. The intervention group included 10 men (47.6%) and 11 women (52.4%); the control group included 6 men (26.1%) and 17 women (73.9%). Baseline IGD scores were 25.86 (SD=5.09) and 23.74 (SD=4.75), respectively, with no significant between-group difference.
Participant flow
Sixty-five individuals were assessed for eligibility, and two were excluded because they did not meet the eligibility criteria. Sixty-three participants were randomized to the intervention group (n=31) or control group (n=32). In the intervention group, 10 participants were excluded from the primary analysis because of insufficient attendance at the scheduled intervention sessions or incomplete assessments, leaving 21 participants for analysis. In the control group, 9 participants did not complete all assessments, leaving 23 participants for analysis. The completer analysis therefore included 44 participants. Post-intervention and one-month follow-up outcome data were unavailable for the 19 participants who discontinued after randomization.
Adverse events
No serious or other reported adverse events related to the intervention were observed during the study period.
Outcome measures
The primary outcome was the IGD score. In a linear mixed effects model based on 44 completers, the overall group by time interaction was significant. The likelihood ratio chi square value was 14.03 with 2 degrees of freedom, and p was less than 0.001. From baseline to immediately after the intervention, the mean change was -2.86 points in the intervention group and 2.30 points in the control group. The between group difference in change was -5.16 points, with a 95 percent confidence interval from -7.81 to -2.51, p less than 0.001, and Hedges g of -1.03. From baseline to the one month follow up, the between group difference in change was -1.67 points, with a 95 percent confidence interval from -4.31 to 0.98 and p equal to 0.217. This difference was not statistically significant. No significant group by time interactions were observed for K6 psychological distress, self esteem, self control, or the motivational outcomes. This was a completer analysis, and a full intention to treat analysis could not be conducted.
Plan to share IPD
No plan to share individual participant data.
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2024 | Year | 02 | Month | 14 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 04 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 10 | 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 | 08 | Month | 09 | Day |
Last modified on
| 2026 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000063085
