- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04257890
A Cognitive Behavioral Therapy Intervention for Internet Gaming Disorder
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 Overview
Status
Conditions
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Hong Kong
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Hong Kong, Hong Kong, China
- Active, not recruiting
- HKMLC Queen Maud Secondary School
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Hong Kong, Hong Kong
- Recruiting
- Henrietta Secondary School
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Contact:
- Phone Number: 25701466
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Hong Kong, Hong Kong
- Active, not recruiting
- Po Kok Secondary School
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Hong Kong, Hong Kong
- Active, not recruiting
- Po Leung Kuk Lee Shing Pik College
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Hong Kong, Hong Kong
- Active, not recruiting
- S.T.F.A. Lee Shau Kee College
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Hong Kong, Hong Kong
- Recruiting
- Shun Tak Fraternal Association Leung Kau Kui College
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Contact:
- Phone Number: 2458 0766
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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EXPERIMENTAL: CBT intervention group
In addition to the information about IGD of the control group, the intervention group will receive eight weekly group-based 90-minute CBT sessions.
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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.
Printed education material introducing IGD will be distributed.
Printed education material introducing CBT will be distributed.
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ACTIVE_COMPARATOR: Wait-list control group
Members will receive printed education material about IGD but not CBT during the treatment period.
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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.
Printed education material introducing IGD will be distributed.
Printed education material introducing CBT will be distributed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change from baseline Internet gaming disorder (IGD) immediately after the interventions
Time Frame: immediately after the interventions
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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.
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immediately after the interventions
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Change from baseline Internet gaming disorder (IGD) at 6 months
Time Frame: six months after the interventions
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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.
|
six months after the interventions
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14607319
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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