Internet Gaming DisorderNCT04257890
A Cognitive Behavioral Therapy Intervention for Internet Gaming Disorder
A study testing Cognitive behavioral therapy, Education material about IGD and Education material about CBT in people with Internet Gaming Disorder, run by Chinese University of Hong Kong at 6 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Internet Gaming Disorder
- What is being tested?
- Cognitive behavioral therapy, Education material about IGD and Education material about CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 19 Mar 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Hong Kong5 sites, 2 recruiting
- Recruiting
Henrietta Secondary School
Hong Kong
25701466
- Active, not recruiting
Po Kok Secondary School
Hong Kong
- Active, not recruiting
Po Leung Kuk Lee Shing Pik College
Hong Kong
- Active, not recruiting
S.T.F.A. Lee Shau Kee College
Hong Kong
- Recruiting
Shun Tak Fraternal Association Leung Kau Kui College
Hong Kong
2458 0766
China1 site
- Active, not recruiting
HKMLC Queen Maud Secondary School
Hong Kong, Hong Kong
About this study
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
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.
Read the 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.
- Conditions
- Internet Gaming Disorder
- Being tested
- Cognitive behavioral therapy, Education material about IGD, Education material about CBT
- Medical subject headings
- Internet Addiction Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapyBehavioural
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 IGDOther
Printed education material introducing IGD will be distributed.
Education material about CBTOther
Printed education material introducing CBT will be distributed.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Cognitive behavioral therapy; Other: Education material about IGD; Other: Education material about CBT |
| Wait-list control group | Active comparator | Members will receive printed education material about IGD but not CBT during the treatment period. Receives: Behavioral: Cognitive behavioral therapy; Other: Education material about IGD; Other: Education material about CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: immediately after the interventions
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.
Measured: six months after the interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start19 Mar 2021
- Primary completion30 Nov 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Internet Gaming DisorderStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 226 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Xue YANG, Chinese University of Hong Kong
- Investigators
- Xue Yang, Principal investigator, JC School of Public Health and Primary Care, Faculty of Medicine, CUHK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04257890
- Sponsor's protocol ID
- 14607319
- Status last verified
- Jul 2021
- First submitted
- 27 Dec 2019
- Last updated
- 2 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04257890
- Acronym / sponsor ID
- 14607319
- Conditions
- Internet Gaming Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 226 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 19 Mar 2021 (actual)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 6 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT intervention group | Experimental | Behavioral: Cognitive behavioral therapy, Other: Education material about IGD, Other: Education material about CBTIn addition to the information about IGD of the control group, the intervention group will receive eight weekly group-based 90-minute CBT sessions. |
| Wait-list control group | Active comparator | Behavioral: Cognitive behavioral therapy, Other: Education material about IGD, Other: Education material about CBTMembers will receive printed education material about IGD but not CBT during the treatment period. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive behavioral therapyThe 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. | Behavioural | CBT intervention group, Wait-list control group |
| Education material about IGDPrinted education material introducing IGD will be distributed. | Other | CBT intervention group, Wait-list control group |
| Education material about CBTPrinted education material introducing CBT will be distributed. | Other | CBT intervention group, Wait-list control group |
Primary outcome
Change from baseline Internet gaming disorder (IGD) immediately after the interventions
Time frame: 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.
Change from baseline Internet gaming disorder (IGD) at 6 months
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xue Yang principal investigator
JC School of Public Health and Primary Care, Faculty of Medicine, CUHK
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioral therapy, Education material about IGD and Education material about CBT in people with Internet Gaming Disorder, run by Chinese University of Hong Kong at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Hong Kong, China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xue Yang, PhD (+852 2252 8740, sherryxueyang@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Internet gaming disorder (IGD) immediately after the interventions (time frame: immediately after the interventions). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2021.