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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04257890
Other study ID # 14607319
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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