Clinical trial NCT04257890: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Internet Gaming Disorder
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2020-02-06
Enrollment: 226
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from baseline Internet gaming disorder (IGD) immediately after the interventions
timeFrame: immediately after the interventions
measure: Change from baseline Internet gaming disorder (IGD) at 6 months
timeFrame: six months after the interventions
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: HKMLC Queen Maud Secondary School
state: Hong Kong
city: Hong Kong
country: Hong Kong
facility: Henrietta Secondary School
city: Hong Kong
country: Hong Kong
facility: Po Kok Secondary School
city: Hong Kong
country: Hong Kong
facility: Po Leung Kuk Lee Shing Pik College
city: Hong Kong
country: Hong Kong
facility: S.T.F.A. Lee Shau Kee College
city: Hong Kong
country: Hong Kong
facility: Shun Tak Fraternal Association Leung Kau Kui College
Study officials:
affiliation: JC School of Public Health and Primary Care, Faculty of Medicine, CUHK
name: Xue Yang
role: PRINCIPAL_INVESTIGATOR
References: