A Cognitive Behavioral Therapy Intervention for Internet Gaming Disorder

Internet Gaming Disorder Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04257890
• Other study ID #: 14607319
• Status: Recruiting
• Phase: N/A
• Start date: March 19, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: July 2021
• Source: Chinese University of Hong Kong
• Contact: Xue Yang, PhD
• Phone: +852 2252 8740
• Email: sherryxueyang[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 226
• Est. completion date: December 31, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Disease
• Internet Gaming Disorder

Intervention

Behavioral:
• Cognitive behavioral therapy
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.

Other:
• Education material about IGD
Printed education material introducing IGD will be distributed.
• Education material about CBT
Printed education material introducing CBT will be distributed.

Locations

Country	Name	City	State
China	HKMLC Queen Maud Secondary School	Hong Kong	Hong Kong
Hong Kong	Henrietta Secondary School	Hong Kong
Hong Kong	Po Kok Secondary School	Hong Kong
Hong Kong	Po Leung Kuk Lee Shing Pik College	Hong Kong
Hong Kong	S.T.F.A. Lee Shau Kee College	Hong Kong
Hong Kong	Shun Tak Fraternal Association Leung Kau Kui College	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Countries where clinical trial is conducted

China,  Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	immediately after the interventions
Primary	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.	six months after the interventions