跳至主要内容
临床试验/NCT04257890
NCT04257890Unknown不适用

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

Chinese University of Hong Kong6 个研究点 分布在 2 个国家目标入组 226 人开始时间: 2021年3月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
226
试验地点
6
主要终点
Change from baseline Internet gaming disorder (IGD) at 6 months

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
12 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

CBT intervention group

Experimental

In addition to the information about IGD of the control group, the intervention group will receive eight weekly group-based 90-minute CBT sessions.

干预措施: Cognitive behavioral therapy (Behavioral)

CBT intervention group

Experimental

In addition to the information about IGD of the control group, the intervention group will receive eight weekly group-based 90-minute CBT sessions.

干预措施: Education material about IGD (Other)

CBT intervention group

Experimental

In addition to the information about IGD of the control group, the intervention group will receive eight weekly group-based 90-minute CBT sessions.

干预措施: Education material about CBT (Other)

Wait-list control group

Active Comparator

Members will receive printed education material about IGD but not CBT during the treatment period.

干预措施: Cognitive behavioral therapy (Behavioral)

Wait-list control group

Active Comparator

Members will receive printed education material about IGD but not CBT during the treatment period.

干预措施: Education material about IGD (Other)

Wait-list control group

Active Comparator

Members will receive printed education material about IGD but not CBT during the treatment period.

干预措施: Education material about CBT (Other)

结局指标

主要结局

Change from baseline Internet gaming disorder (IGD) at 6 months

时间窗: six months 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) immediately after the interventions

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Xue YANG

Research Assistant Professor

Chinese University of Hong Kong

研究点 (6)

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