A Cognitive Behavioral Therapy Intervention for Internet Gaming Disorder

NCT ID: NCT04257890

Last Updated: 2021-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

226 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-19

Study Completion Date

2022-12-31

Brief Summary

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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

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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.

Conditions

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Internet Gaming Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Cognitive behavioral therapy

Intervention Type BEHAVIORAL

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.

Education material about IGD

Intervention Type OTHER

Printed education material introducing IGD will be distributed.

Education material about CBT

Intervention Type OTHER

Printed education material introducing CBT will be distributed.

Wait-list control group

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

Group Type ACTIVE_COMPARATOR

Cognitive behavioral therapy

Intervention Type BEHAVIORAL

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.

Education material about IGD

Intervention Type OTHER

Printed education material introducing IGD will be distributed.

Education material about CBT

Intervention Type OTHER

Printed education material introducing CBT will be distributed.

Interventions

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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.

Intervention Type BEHAVIORAL

Education material about IGD

Printed education material introducing IGD will be distributed.

Intervention Type OTHER

Education material about CBT

Printed education material introducing CBT will be distributed.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Dr. Xue YANG

Research Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xue Yang

Role: PRINCIPAL_INVESTIGATOR

JC School of Public Health and Primary Care, Faculty of Medicine, CUHK

Locations

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HKMLC Queen Maud Secondary School

Hong Kong, Hong Kong, China

Site Status ACTIVE_NOT_RECRUITING

Henrietta Secondary School

Hong Kong, , Hong Kong

Site Status RECRUITING

Po Kok Secondary School

Hong Kong, , Hong Kong

Site Status ACTIVE_NOT_RECRUITING

Po Leung Kuk Lee Shing Pik College

Hong Kong, , Hong Kong

Site Status ACTIVE_NOT_RECRUITING

S.T.F.A. Lee Shau Kee College

Hong Kong, , Hong Kong

Site Status ACTIVE_NOT_RECRUITING

Shun Tak Fraternal Association Leung Kau Kui College

Hong Kong, , Hong Kong

Site Status RECRUITING

Countries

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China Hong Kong

Central Contacts

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Xue Yang, PhD

Role: CONTACT

+852 2252 8740

Facility Contacts

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Role: primary

25701466

Role: primary

2458 0766

Other Identifiers

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14607319

Identifier Type: -

Identifier Source: org_study_id

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