Internet Gaming DisorderNCT06821373
Chatbot Intervention to Reduce Common Digital Addictions, Sedentary Behaviors and Mental Distress Among Adolescents
A study testing Chatbot in people with Internet Gaming Disorder and Social Media Addiction, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
The goal of the study is to investigate the efficacy of a secondary low-intensity stage of change (SoC) and motivational interviewing (MI)-based Chatbot-assisted intervention in reducing digital addictions in adolescents with Internet gaming disorder (IGD) and/or social media addiction (SMA) by conducting a RCT. Read more about this study
- Who is it for?
- Ages 10 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Internet Gaming Disorder, Social Media Addiction
- What is being tested?
- Chatbot
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 330 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Sep 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 10 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Students at grades 5-6 in primary schools or grades 7-12 in secondary schools,
- Positive screening results of IGD and/or SMA) based on the validated screening tools
- Using smartphone or Internet on a daily base, 4) students' and parental consent,
- Chinese speaking.
Who cannot join
- Current use of any psychotropic medication.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
JC School of Public Health and Primary Care, The Chinese University of Hong Kong
Hong Kong
Xue Yang, Doctoral, +85256237005, sherryxueyang@cuhk.edu.hk
Xue Yang, Doctoral
About this study
Official title: Developing and Evaluating a Low-intensity Secondary Theory-based Chatbot Intervention to Reduce Common Digital Addictions, Sedentary Behaviors and Mental Distress Among Adolescents: A Randomized Controlled Trial
The goal of the study is to investigate the efficacy of a secondary low-intensity stage of change (SoC) and motivational interviewing (MI)-based Chatbot-assisted intervention in reducing digital addictions in adolescents with Internet gaming disorder (IGD) and/or social media addiction (SMA) by conducting a RCT.
Hypothesis: The intervention group will show a greater reduction in rates of IGD and/or SMA at post-treatment and 3-month follow-up than the control group.
Read more
Design and subjects: A two-armed RCT between the intervention group and psycho-educational control group for adolescents aged 10-19 with excessive screen time. Screening, baseline, post-programme, and 3-month follow-up evaluations will be conducted.
Participants will:
Be randomly assigned to online brief intervention or psycho-educational control
Complete questionnaires evaluating 1 ) Primary outcomes (IGD, SMA), 2) Secondary outcomes (sedentary lifestyle, mental distress, quality of life, eHealth literacy) and 3) Mediators/mechanisms (autonomy, competence)
- Conditions
- Internet Gaming Disorder, Social Media Addiction
- Being tested
- Chatbot, Control
- Keywords
- Internet gaming disorder, Chatbot, Social media addiction, Stage of change, motivation enhancement, Low-intensity, Sedentary lifestyle, Adolescent mental health
- Medical subject headings
- Internet Addiction Disorder, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChatbotBehavioural
The intervention includes five modules based on the five stages of Stages of change. Chatbots will build up a rapport with the participants, monitor their stage with a few simple questions based on previous Stages of Change studies, and provide stage-tailored packages of response, advice, and feedback (one of the five modules) accordingly to enhance their motivation and self-efficacy each week. For those who click 'yes' to a question assessing the first stage of change (PC), Chatbot will make a record and automatically ask questions assessing the next stage; for those who click 'no', Chatbot will automatically send them the module corresponding to their SoC via WhatsApp. Each module will take 10-15 minutes. In total, it will take 1 hour to complete all the modules.
ControlBehavioural
The intervention includes five modules based on the five stages of Stages of change. Chatbots will build up a rapport with the participants, monitor their stage with a few simple questions based on previous Stages of Change studies, and provide stage-tailored packages of response, advice, and feedback (one of the five modules) accordingly to enhance their motivation and self-efficacy each week. For those who click 'yes' to a question assessing the first stage of change (PC), Chatbot will make a record and automatically ask questions assessing the next stage; for those who click 'no', Chatbot will automatically send them the module corresponding to their SoC via WhatsApp. Each module will take 10-15 minutes. In total, it will take 1 hour to complete all the modules.
| Study group | Role | What they receive |
|---|---|---|
| Control | Sham comparator | Participants will receive educational but not SoC and MI-based materials about excessive digital use, IGD, and SMA. Such psycho-educational interventions are widely used in behavioral/mental health promotion and have been demonstrated to be effective in increasing knowledge and awareness of behavioral and mental problems. Based on a comprehensive literature review and our previous psycho-educational programs for behavioral/mental health promotion, the research team will design the psycho-educational materials. Themes include definitions, factors, and health consequences of excessive digital use, IGD, and SMA, information on healthy lifestyles, self-regulation skills, and help-seeking resources. Receives: Behavioral: Control |
| Chatbot | Experimental | The intervention includes five modules based on the five stages of Stages of change. Chatbots will build up a rapport with the participants, monitor their stage with a few simple questions based on previous Stages of Change studies, and provide stage-tailored packages of response, advice, and feedback (one of the five modules) accordingly to enhance their motivation and self-efficacy each week. For those who click 'yes' to a question assessing the first stage of change (PC), Chatbot will make a record and automatically ask questions assessing the next stage; for those who click 'no', Chatbot will automatically send them the module corresponding to their SoC via WhatsApp. Each module will take 10-15 minutes. In total, it will take 1 hour to complete all the modules. Receives: Behavioral: Chatbot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Internet gaming disorder (IGD)
IGD symptoms are assessed using the Nine-Item Internet Gaming Disorder Scale-Short Form (IGDS9-SF) consists of nine questions that assess IGD symptoms, including 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. The response options for each item include "yes=1" and "no=0". The overall score of the scale ranges from 0 to 9, with a higher score implying a higher level of IGD symptoms. Participants with score ≥ 5 will be classified as having probable IGD.
Measured: From enrollment to the end of follow-up at 3 months
Social media addiction (SMA)
SMA is defined as excessive use of social media with the addictive symptoms like mood modification, salience, tolerance, withdrawal symptoms, conflict, and relapse. The symptoms of SMA will be measured by the 6-item Bergen Social Media Addiction Scale (BSMAS) based on the six core components of addictive behaviors, including cognitive salience, tolerance, mood modification, difficulty in regulating use, withdrawal, and interference with role performance. The items are rated using a Likert type scale ranging between 1 (very rarely) and 5 (very often). A higher sum score in the BSMAS indicates a greater likelihood of being at risk of developing social media addiction. A cut-off score over 19 indicates probable SMA.
Measured: From enrollment to end of follow-up at 3 months
Composite score of IGD and SMA
Composite outcome of IGD score and SMA score: we define a simple composite as the sum of the two outcomes. Because each outcome measure uses a different scale and has different statistical properties, we will standardize the two variables (i.e., scores of IGD and SMA) first, and then combine the two standardized scores of the outcomes into a composite.
Measured: From enrollment to end of follow-up at 3 months.
Secondary outcomes (5)
Sedentary lifestyle
Sedentary behavior is defined as any waking behavior such as sitting or leaning with an energy expenditure of 1.5 metabolic equivalent task (MET) or less. Sedentary lifestyles will be measured by the 10-item sedentary lifestyles questionnaire (SLQ) which has been used in Chinese school children. Subjects will report the average daily time spent (hours) during the weekdays and weekends in the following activities: Using smartphone or tablet PC for learning/doing paper homework or reading or writing/ sedentary leisure time without time for screen leisure. Average number of daily hours will be calculated as (total sedentary weekday hours × 5 + total sedentary weekend hours × 2) ÷ 7.
Measured: From enrollment to end of 3 months follow-up
Entertainment screen time
The American Academy of Pediatrics has recommended that time allotted to Internet gaming or the total amount of entertainment screen time in general (e.g., using social media platforms/social networking sites, watching TV/videos) should be <1 to 2 hours per day for children and adolescents given the significant health consequences of excessive Internet gaming and screen time. Thus, participants who report the total amount of entertainment screen time with two or more hours per day will be classified as excessive screen time cases and positive cases in our school-based screening.
Measured: From enrollment to end of follow-up at 3 months
Health-related Quality of life
Quality of life will be measured by the EQ-5D-Y scale (Y for youth). The EQ-5D-Y uses a similar 5-dimenional descriptive system with the EQ-5D but child-friendly wording, referring to mobility ('walking about'), self-care ('looking after myself'), usual activities ('doing usual activities'), pain and discomfort ('having pain or discomfort'), and anxiety and depression ('feeling worried, sad or unhappy'). Each dimension includes one item which has three functioning levels: no problem, some problems, and a lot of problems. The EQ-5D-Y also includes an easily understandable modification of the vertical, graduated Visual Analogue Scale (VAS) of EQ-5D, where the respondent rates his or her overall health status on a scale from 0 to 100 with 0 representing the worst and 100 the best health state the individual can imagine.
Measured: From enrollment to end of follow-up at 3 months
Mental distress
Mental distress is defined as a collection of mental problems that may not fall into standard diagnostic criteria and are characterized by symptoms of sleeplessness, depression, anxiety, exhaustion, irritability, poor memory, difficulty in concentrating, and somatic complaints. The Chinese K6 questionnaire comprises six questions that ask respondents to rate how frequently they have felt 'nervous', 'hopeless', 'restless or fidgety', 'so depressed that nothing could cheer you up', 'that everything was an effort', and 'worthless' during the past 30 days. Response options included 'none of the time' (0), 'a little of the time' (1), 'some of the time' (2), 'most of the time' (3), and 'all of the time' (4). The range of score for K6 was thus from 0 to 24.
Measured: From enrollment to end of follow-up at 3 months
eHealth literacy
eHealth literacy is defined as the ability of individuals to seek, find, understand, and appraise health information from electronic sources and apply such information to addressing or solving a health problem. eHealth literacy will be assessed by the 8-item eHealth Literacy Scale (eHEAL), which was validated in Chinese student population. The sample items include 'I know how to find helpful resources on the internet' and 'I know how to use the internet to answer my questions about health'. Ratings were made on 5-point Likert scales, ranging from 1= strongly disagree to 5 = strongly agree, with higher scores indicating a higher level of eHealth literacy.
Measured: From enrollment to end of follow-up at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start1 Sep 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 330 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, Doctoral, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06821373
- Sponsor's protocol ID
- 20210481
- Status last verified
- Feb 2025
- First submitted
- 4 Feb 2025
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yang X, Wang X, Tse NK, Wang Z, Mak WWS, Mo PK, Wong SY, Zhang Q, Zhang L. Effects of low-intensity secondary theory-based Chatbot intervention for adolescents with digital addictions: protocol for a randomized controlled trial. BMC Psychiatry. 2026 Jul 27;26(1):828. doi: 10.1186/s12888-026-08375-5.
PubMed 42934631
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Evaluating a Low-intensity Secondary Theory-based Chatbot Intervention to Reduce Common Digital Addictions, Sedentary Behaviors and Mental Distress Among Adolescents: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06821373
- Acronym / sponsor ID
- 20210481
- Conditions
- Internet Gaming Disorder, Social Media Addiction
- Keywords
- Internet gaming disorder, Chatbot, Social media addiction, Stage of change, motivation enhancement, Low-intensity, Sedentary lifestyle, Adolescent mental health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 12 Feb 2025 (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.
The goal of the study is to investigate the efficacy of a secondary low-intensity stage of change (SoC) and motivational interviewing (MI)-based Chatbot-assisted intervention in reducing digital addictions in adolescents with Internet gaming disorder (IGD) and/or social media addiction (SMA) by conducting a RCT.
Hypothesis: The intervention group will show a greater reduction in rates of IGD and/or SMA at post-treatment and 3-month follow-up than the control group.
Design and subjects: A two-armed RCT between the intervention group and psycho-educational control group for adolescents aged 10-19 with excessive screen time. Screening, baseline, post-programme, and 3-month follow-up evaluations will be conducted.
Participants will:
Be randomly assigned to online brief intervention or psycho-educational control
Complete questionnaires evaluating 1 ) Primary outcomes (IGD, SMA), 2) Secondary outcomes (sedentary lifestyle, mental distress, quality of life, eHealth literacy) and 3) Mediators/mechanisms (autonomy, competence)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Sham comparator | Behavioral: ControlParticipants will receive educational but not SoC and MI-based materials about excessive digital use, IGD, and SMA. Such psycho-educational interventions are widely used in behavioral/mental health promotion and have been demonstrated to be effective in increasing knowledge and awareness of behavioral and mental problems. Based on a comprehensive literature review and our previous psycho-educational programs for behavioral/mental health promotion, the research team will design the psycho-educational materials. Themes include definitions, factors, and health consequences of excessive digital use, IGD, and SMA, information on healthy lifestyles, self-regulation skills, and help-seeking resources. |
| Chatbot | Experimental | Behavioral: ChatbotThe intervention includes five modules based on the five stages of Stages of change. Chatbots will build up a rapport with the participants, monitor their stage with a few simple questions based on previous Stages of Change studies, and provide stage-tailored packages of response, advice, and feedback (one of the five modules) accordingly to enhance their motivation and self-efficacy each week. For those who click 'yes' to a question assessing the first stage of change (PC), Chatbot will make a record and automatically ask questions assessing the next stage; for those who click 'no', Chatbot will automatically send them the module corresponding to their SoC via WhatsApp. Each module will take 10-15 minutes. In total, it will take 1 hour to complete all the modules. |
Who may qualify
- Ages
- 10 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Students at grades 5-6 in primary schools or grades 7-12 in secondary schools,
- Positive screening results of IGD and/or SMA) based on the validated screening tools
- Using smartphone or Internet on a daily base, 4) students' and parental consent,
- Chinese speaking.
Key exclusion criteria (1 listed)
- Current use of any psychotropic medication.
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 |
|---|---|---|
| ChatbotThe intervention includes five modules based on the five stages of Stages of change. Chatbots will build up a rapport with the participants, monitor their stage with a few simple questions based on previous Stages of Change studies, and provide stage-tailored packages of response, advice, and feedback (one of the five modules) accordingly to enhance their motivation and self-efficacy each week. For those who click 'yes' to a question assessing the first stage of change (PC), Chatbot will make a record and automatically ask questions assessing the next stage; for those who click 'no', Chatbot will automatically send them the module corresponding to their SoC via WhatsApp. Each module will take 10-15 minutes. In total, it will take 1 hour to complete all the modules. | Behavioural | Chatbot |
| ControlThe intervention includes five modules based on the five stages of Stages of change. Chatbots will build up a rapport with the participants, monitor their stage with a few simple questions based on previous Stages of Change studies, and provide stage-tailored packages of response, advice, and feedback (one of the five modules) accordingly to enhance their motivation and self-efficacy each week. For those who click 'yes' to a question assessing the first stage of change (PC), Chatbot will make a record and automatically ask questions assessing the next stage; for those who click 'no', Chatbot will automatically send them the module corresponding to their SoC via WhatsApp. Each module will take 10-15 minutes. In total, it will take 1 hour to complete all the modules. | Behavioural | Control |
Primary outcome
Internet gaming disorder (IGD)
Time frame: From enrollment to the end of follow-up at 3 months
IGD symptoms are assessed using the Nine-Item Internet Gaming Disorder Scale-Short Form (IGDS9-SF) consists of nine questions that assess IGD symptoms, including 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. The response options for each item include "yes=1" and "no=0". The overall score of the scale ranges from 0 to 9, with a higher score implying a higher level of IGD symptoms. Participants with score ≥ 5 will be classified as having probable IGD.
Social media addiction (SMA)
Time frame: From enrollment to end of follow-up at 3 months
SMA is defined as excessive use of social media with the addictive symptoms like mood modification, salience, tolerance, withdrawal symptoms, conflict, and relapse. The symptoms of SMA will be measured by the 6-item Bergen Social Media Addiction Scale (BSMAS) based on the six core components of addictive behaviors, including cognitive salience, tolerance, mood modification, difficulty in regulating use, withdrawal, and interference with role performance. The items are rated using a Likert type scale ranging between 1 (very rarely) and 5 (very often). A higher sum score in the BSMAS indicates a greater likelihood of being at risk of developing social media addiction. A cut-off score over 19 indicates probable SMA.
Composite score of IGD and SMA
Time frame: From enrollment to end of follow-up at 3 months.
Composite outcome of IGD score and SMA score: we define a simple composite as the sum of the two outcomes. Because each outcome measure uses a different scale and has different statistical properties, we will standardize the two variables (i.e., scores of IGD and SMA) first, and then combine the two standardized scores of the outcomes into a composite.
5 secondary outcomes
Sedentary lifestyle
Time frame: From enrollment to end of 3 months follow-up
Entertainment screen time
Time frame: From enrollment to end of follow-up at 3 months
Health-related Quality of life
Time frame: From enrollment to end of follow-up at 3 months
Mental distress
Time frame: From enrollment to end of follow-up at 3 months
eHealth literacy
Time frame: From enrollment to end of follow-up at 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Derived from this study: PubMed 42934631Yang X, Wang X, Tse NK, Wang Z, Mak WWS, Mo PK, Wong SY, Zhang Q, Zhang L. Effects of low-intensity secondary theory-based Chatbot intervention for adolescents with digital addictions: protocol for a randomized controlled trial. BMC Psychiatry. 2026 Jul 27;26(1):828. doi: 10.1186/s12888-026-08375-5.
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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.
Xue Yang, Doctoral principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chatbot in people with Internet Gaming Disorder and Social Media Addiction, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 1 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: looking for participants now, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xue Yang, Doctoral (+85256237005, sherryxueyang@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Internet gaming disorder (IGD) (time frame: From enrollment to the end of follow-up at 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06821373, which also lists 1 linked publication.
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 12 Feb 2025.