UMIN-CTR 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 2024/08/09 16:35:23

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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

Email

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


Email

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

Email

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


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled

43

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

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

2024 Year 08 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063085