A Cognitive Behavioral Therapy Intervention for Internet Gaming Disorder
Primary Purpose
Internet Gaming Disorder
Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Cognitive behavioral therapy
Education material about IGD
Education material about CBT
Sponsored by
About this trial
This is an interventional treatment trial for Internet Gaming Disorder
Eligibility Criteria
Inclusion Criteria:
- secondary 1-4 students (grade 7-10),
- positive screening results (i.e. IGD cases) according to a validated questionnaire (the 5 DSM-5 criteria for IGD),
- students' and parental consent,
- Chinese speaking.
Exclusion Criteria:
- self-reported history of any psychiatric or neurological illness,
- current use of any psychotropic medication.
We do not include Secondary 5-6 students due to their preparation for public examinations and practical difficulty in follow-up after their graduation.
Sites / Locations
- HKMLC Queen Maud Secondary School
- Henrietta Secondary SchoolRecruiting
- Po Kok Secondary School
- Po Leung Kuk Lee Shing Pik College
- S.T.F.A. Lee Shau Kee College
- Shun Tak Fraternal Association Leung Kau Kui CollegeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CBT intervention group
Wait-list control group
Arm Description
In addition to the information about IGD of the control group, the intervention group will receive eight weekly group-based 90-minute CBT sessions.
Members will receive printed education material about IGD but not CBT during the treatment period.
Outcomes
Primary Outcome Measures
Change from baseline Internet gaming disorder (IGD) immediately after the interventions
The DSM-5 classification of IGD: The 9-item IGD checklist is a short, user-friendly, self-report measure for assessing the DSM-5 classification of IGD. Symptoms to be assessed include preoccupation, tolerance, withdrawal, unsuccessful attempts to limit gaming, deception or lies about gaming, loss of interest in other activities, use despite knowledge of harm, use for escape or relief of negative mood, and harm in the past 12 months. Response options are no (0) and yes (1). As per the DSM-5 recommendation, those with >=5 'yes' responses are considered IGD cases. The Chinese version has been validated with high internal consistency.
Change from baseline Internet gaming disorder (IGD) at 6 months
The DSM-5 classification of IGD: The 9-item IGD checklist is a short, user-friendly, self-report measure for assessing the DSM-5 classification of IGD. Symptoms to be assessed include preoccupation, tolerance, withdrawal, unsuccessful attempts to limit gaming, deception or lies about gaming, loss of interest in other activities, use despite knowledge of harm, use for escape or relief of negative mood, and harm in the past 12 months. Response options are no (0) and yes (1). As per the DSM-5 recommendation, those with >=5 'yes' responses are considered IGD cases. The Chinese version has been validated with high internal consistency.
Secondary Outcome Measures
Full Information
NCT ID
NCT04257890
First Posted
December 27, 2019
Last Updated
July 29, 2021
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT04257890
Brief Title
A Cognitive Behavioral Therapy Intervention for Internet Gaming Disorder
Official Title
A Randomized Controlled Trial for Evaluating the Efficacy of a Cognitive Behavioral Therapy Intervention in Reducing Internet Gaming Disorder Among Secondary School Students in Hong Kong
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 19, 2021 (Actual)
Primary Completion Date
November 30, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This RCT study develops a brief group-based CBT intervention. The primary objective is to evaluate the efficacy of the CBT in reducing IGD, compare to a wait-list control group.
Detailed Description
Introduction Cognitive behavioral therapy (CBT) is potentially useful as it is effective in treating mental/behavioral disorders, restructuring cognitions and cultivating positive coping. A gap exists as the only two existing clinic-based small randomized controlled trials (RCT) yielded mixed findings on CBT's treatment effect for adolescent IGD.
Objectives This RCT study develops a brief group-based CBT intervention. The primary objective is to evaluate the efficacy of the CBT in reducing IGD, compare to a wait-list control group.
Subjects and methods The study design is two-armed RCT. The participants are Secondary 1-4 students (n=226) with IGD (DSM-5 classification) identified in a school-based screening. Evaluation involves surveys at baseline, end of CBT intervention, and 6 months afterwards. In addition to information received by the wait-list control group, the intervention group receives a carefully designed brief 8-week group-based CBT. The control group will receive CBT after the 6-month follow-up. Trained social workers of a collaborating NGO that serves secondary school students will conduct the CBT.
Outcomes and measures The primary outcome is IGD (a validated DSM-5 IGD classification tool). Secondary outcomes include time spent on Internet/Internet games and the intention to reduce IGD. Measures of potential mediators (maladaptive beliefs and coping) include: Internet Gaming Cognition Scale, Generalized Problematic Internet Use Scale, Emotion Regulation Questionnaire, and Coping Scale for Children and Youth.
Data analysis Intention-to-treat analysis is performed. The primary outcome is assessed by absolute and relative risk reduction. Generalized Linear Mixed Models and Structural Equation Models are used to test secondary outcomes and mediation effects.
Implications The findings may lead to an evidence-based treatment for adolescent IGD, a newly defined disease, which has been rarely reported in literature. Understanding its mechanism contributes to theoretical development of IGD and related treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Internet Gaming Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
226 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CBT intervention group
Arm Type
Experimental
Arm Description
In addition to the information about IGD of the control group, the intervention group will receive eight weekly group-based 90-minute CBT sessions.
Arm Title
Wait-list control group
Arm Type
Active Comparator
Arm Description
Members will receive printed education material about IGD but not CBT during the treatment period.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral therapy
Intervention Description
The CBT focuses on cognitive restructuring to reduce the specific key maladaptive beliefs on Internet gaming suggested by King's model, and develop useful coping skills (self-regulation/control, emotion regulation, problem-solving coping) that are adapted from previous CBT for adolescent IGD. In addition, it provides training on relapse-prevention and maintenance techniques.
Intervention Type
Other
Intervention Name(s)
Education material about IGD
Intervention Description
Printed education material introducing IGD will be distributed.
Intervention Type
Other
Intervention Name(s)
Education material about CBT
Intervention Description
Printed education material introducing CBT will be distributed.
Primary Outcome Measure Information:
Title
Change from baseline Internet gaming disorder (IGD) immediately after the interventions
Description
The DSM-5 classification of IGD: The 9-item IGD checklist is a short, user-friendly, self-report measure for assessing the DSM-5 classification of IGD. Symptoms to be assessed include preoccupation, tolerance, withdrawal, unsuccessful attempts to limit gaming, deception or lies about gaming, loss of interest in other activities, use despite knowledge of harm, use for escape or relief of negative mood, and harm in the past 12 months. Response options are no (0) and yes (1). As per the DSM-5 recommendation, those with >=5 'yes' responses are considered IGD cases. The Chinese version has been validated with high internal consistency.
Time Frame
immediately after the interventions
Title
Change from baseline Internet gaming disorder (IGD) at 6 months
Description
The DSM-5 classification of IGD: The 9-item IGD checklist is a short, user-friendly, self-report measure for assessing the DSM-5 classification of IGD. Symptoms to be assessed include preoccupation, tolerance, withdrawal, unsuccessful attempts to limit gaming, deception or lies about gaming, loss of interest in other activities, use despite knowledge of harm, use for escape or relief of negative mood, and harm in the past 12 months. Response options are no (0) and yes (1). As per the DSM-5 recommendation, those with >=5 'yes' responses are considered IGD cases. The Chinese version has been validated with high internal consistency.
Time Frame
six months after the interventions
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
secondary 1-4 students (grade 7-10),
positive screening results (i.e. IGD cases) according to a validated questionnaire (the 5 DSM-5 criteria for IGD),
students' and parental consent,
Chinese speaking.
Exclusion Criteria:
self-reported history of any psychiatric or neurological illness,
current use of any psychotropic medication.
We do not include Secondary 5-6 students due to their preparation for public examinations and practical difficulty in follow-up after their graduation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xue Yang, PhD
Phone
+852 2252 8740
Email
sherryxueyang@cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xue Yang
Organizational Affiliation
JC School of Public Health and Primary Care, Faculty of Medicine, CUHK
Official's Role
Principal Investigator
Facility Information:
Facility Name
HKMLC Queen Maud Secondary School
City
Hong Kong
State/Province
Hong Kong
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Henrietta Secondary School
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
Phone
25701466
Facility Name
Po Kok Secondary School
City
Hong Kong
Country
Hong Kong
Individual Site Status
Active, not recruiting
Facility Name
Po Leung Kuk Lee Shing Pik College
City
Hong Kong
Country
Hong Kong
Individual Site Status
Active, not recruiting
Facility Name
S.T.F.A. Lee Shau Kee College
City
Hong Kong
Country
Hong Kong
Individual Site Status
Active, not recruiting
Facility Name
Shun Tak Fraternal Association Leung Kau Kui College
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
Phone
2458 0766
12. IPD Sharing Statement
Plan to Share IPD
No
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A Cognitive Behavioral Therapy Intervention for Internet Gaming Disorder
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