Internet Gaming DisorderNCT06582979
Effect of Computer-Based Game and HIIT Towards Symptoms, Executive Function and Neuroplasticity in Teens with IGD
A study testing Computer-Based Game Therapy and High-Intensity Interval Training in people with Internet Gaming Disorder, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
The goal of this clinical trial is to learn how effective a combined therapy of computer-based game and also high-intensity interval training (HIIT) physical exercise to improve the clinical symptoms, executive function and neuroplasticity in teenagers with Internet Gaming Disorder (IGD). Read more about this study
- Who is it for?
- Ages 13 to 15 years
- Conditions the study is for
- Internet Gaming Disorder
- What is being tested?
- Computer-Based Game Therapy and High-Intensity Interval Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteIndonesia
- Study dates
- 16 Jan 2025to 21 Jul 2025
- 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 13 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participants who have filled and agreed to the study by signing the informed assent.
- Parents of the participants have filled and agreed to the interventions by signing the informed consent.
- Participants able to follow instruction and procedure of the study
Who cannot join
- Physical disabilities
- Hearing disabilities
- Color blindness
- Respiratory or cardiovascular comorbidities that hinders exercise abilities
- Other psychiatric comorbidities
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Faculty of Medicine, Universitas Indonesia - Dr. Cipto Mangunkusumo General Hospital
Jakarta, DKI Jakarta
About this study
Official title: The Effect of Combined Intervention (Indonesian Computer-Based Game Therapy and High-Intensity Interval Training) Towards Clinical Symptoms, Executive Function and Neuroplasticity in Adolescents with Internet Gaming Disorder: Study Protocol
The goal of this clinical trial is to learn how effective a combined therapy of computer-based game and also high-intensity interval training (HIIT) physical exercise to improve the clinical symptoms, executive function and neuroplasticity in teenagers with Internet Gaming Disorder (IGD). Executive function refers to the brain's ability to manage tasks such as planning, problem-solving, and decision-making. BDNF is a protein crucial for brain health and development. Neuroplasticity is the brain's ability to change and adapt throughout life. High-intensity interval training involves short bursts of intense exercise followed by periods of rest or recovery. The main questions it aims to answer are:
- How effective are computer-based game and HIIT exercises in reducing addiction symptoms of IGD?
- Will computer-based game and HIIT exercise help teens who are addicted to video games to improve their executive function (become more able to plan ahead and meet goals, display self-control and also follow multiple-step directions)?
- Do computer-based game and HIIT exercise help brains of teens with IGD to be more able to change and adapt?
Read more
Researchers will compare the improvement before and after the therapies.
Participants will:
- Undergo both therapies (computer-based game and HIIT) every week for 7 weeks. Computer-based game will be done 3 times/week and HIIT 2 times/week
- fill out forms, interviewed and also have their blood sample taken for a total of three times (before the start of the therapy, during the 4th week of therapy and after the final therapy session on the 7th week)
Read the detailed description
This is a study protocol of a clinical study to examine the effectiveness of computer-based game and high-intensity interval training towards improvement of clinical symptoms, executive function and neuroplasticity in adolescents with Internet Gaming Disorder (IGD).
According to calculations, our study will aim for a minimum of 44 participants using purposive sampling. Participants will drop-out of the study if they missed >10% participation (>3 sessions out of 35 total sessions). Analysis of the effectiveness of both interventions (computer-based game and HIIT exercise) on improvement of clinical symptoms of Internet Gaming Disorder will be done using McNemar test. Meanwhile, analysis of the effectiveness of both interventions towards executive function and neuroplasticity will be done using paired-T tests. Significance levels will be set at 0.05 for analysis. All data will be analyzed using IBM SPSS v. 26.0.
- Conditions
- Internet Gaming Disorder
- Being tested
- Computer-Based Game Therapy, High-Intensity Interval Training
- Keywords
- Indonesia, Computer-based game, High-Intensity Interval Training, Executive Function, Neuroplasticity, Adolescents, Internet Gaming Disorder, Study protocol, Teens
- 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.
Computer-Based Game TherapyBehavioural
Computer-based game intervention will be done three times a week, every morning before school lessons begin or during break time. Researchers will give a brief explanation of the rules on how to play the game before the intervention begins. In the game, participants will act as a fruit truck delivery driver and will have to sort out fruit delivery to different houses according to the instructions of the game. For example, the instruction starts with delivering a yellow-colored banana to a house with a red-colored roof, or delivering a purple-colored grape to a house with a blue-colored roof. Participants will first have to finish a minimum of three tutorial rounds reaching ≥75% correct delivery. Instructions will be divided into four stages; visual stimulus, auditory stimulus, visual stimulus with an obstacle, auditory stimulus with an obstacle. Each round will last for 2 minutes. Total time needed to complete a single computer-based intervention session is around 30-45 minutes.
High-Intensity Interval TrainingBehavioural
HIIT will be done two times a week during physical education hours (in the school's sports field) led by the school's physical education teacher and also certified physical trainers who have undergone training supervised by a sports medicine physician. Before the start of each HIIT session, participants will have their pulse rate assessed with a pulse oximetry and then undergo warm-up for 5 minutes. The duration of each HIIT session will be continuously extended starting at around 4 minutes (1 tabata block/8 moves) during the first week to 8 minutes (2 tabata block/16 moves) during the final week. A single tabata block moveset incorporates 8 total moves; squat jump, push up, high skipping, burpees, isometric front plank, multi jumps on bench, mountain climber in hand plank and lateral sprint (5m). Each move will be done for 20 seconds, followed by a 10 second rest. Pulse rate will be assessed again after the HIIT session and then participants will undergo cooling down and relaxation.
| Study group | Role | What they receive |
|---|---|---|
| Combined Intervention Group | Experimental | This group will experience both computer-based game therapy and also high-intensity interval training for 7 weeks. Receives: Behavioral: Computer-Based Game Therapy; Behavioral: High-Intensity Interval Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Symptoms
Clinical Symptoms of Internet Gaming Disorder evaluated with Ten-Item Internet Gaming Disorder Test (IGDT-10) questionnaire
Measured: Baseline (T0), 4th week of intervention (T1), 7th week of intervention (T2)
Executive Function
Executive Function assessed with Behavior Rating Inventory of Executive Function (BRIEF) questionnaire
Measured: Baseline (T0), 4th week of intervention (T1), 7th week of intervention (T2)
Neuroplasticity
Neuroplasticity measured with serum brain-derived neurotrophic factor (BDNF) levels
Measured: Baseline (T0), 4th week of intervention (T1), 7th week of intervention (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start16 Jan 2025 (estimated)
- Primary completion6 Mar 2025 (estimated)
- Study completion21 Jul 2025 (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 Universitas IndonesiaThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- One group pre and post-test design
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, A M Y Eva Suryani, Universitas Indonesia
- Investigators
- Eva Suryani, dr., Sp.KJ., Principal investigator, Doctoral Program, Faculty of Medicine, Universitas Indonesia/Dr. Cipto Mangunkusumo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06582979
- Sponsor's protocol ID
- 24-03-0436
- Status last verified
- Aug 2024
- First submitted
- 31 Aug 2024
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Combined Intervention (Indonesian Computer-Based Game Therapy and High-Intensity Interval Training) Towards Clinical Symptoms, Executive Function and Neuroplasticity in Adolescents with Internet Gaming Disorder: Study Protocol
- ClinicalTrials.gov ID
- NCT06582979
- Acronym / sponsor ID
- 24-03-0436
- Conditions
- Internet Gaming Disorder
- Keywords
- Indonesia, Computer-based game, High-Intensity Interval Training, Executive Function, Neuroplasticity, Adolescents, Internet Gaming Disorder, Study protocol
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 16 Jan 2025 (estimated)
- Primary completion
- 6 Mar 2025 (estimated)
- Study completion
- 21 Jul 2025 (estimated)
- First posted
- 3 Sep 2024 (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 this clinical trial is to learn how effective a combined therapy of computer-based game and also high-intensity interval training (HIIT) physical exercise to improve the clinical symptoms, executive function and neuroplasticity in teenagers with Internet Gaming Disorder (IGD). Executive function refers to the brain's ability to manage tasks such as planning, problem-solving, and decision-making. BDNF is a protein crucial for brain health and development. Neuroplasticity is the brain's ability to change and adapt throughout life. High-intensity interval training involves short bursts of intense exercise followed by periods of rest or recovery. The main questions it aims to answer are:
- How effective are computer-based game and HIIT exercises in reducing addiction symptoms of IGD?
- Will computer-based game and HIIT exercise help teens who are addicted to video games to improve their executive function (become more able to plan ahead and meet goals, display self-control and also follow multiple-step directions)?
- Do computer-based game and HIIT exercise help brains of teens with IGD to be more able to change and adapt?
Researchers will compare the improvement before and after the therapies.
Participants will:
- Undergo both therapies (computer-based game and HIIT) every week for 7 weeks. Computer-based game will be done 3 times/week and HIIT 2 times/week
- fill out forms, interviewed and also have their blood sample taken for a total of three times (before the start of the therapy, during the 4th week of therapy and after the final therapy session on the 7th week)
Detailed description
This is a study protocol of a clinical study to examine the effectiveness of computer-based game and high-intensity interval training towards improvement of clinical symptoms, executive function and neuroplasticity in adolescents with Internet Gaming Disorder (IGD).
According to calculations, our study will aim for a minimum of 44 participants using purposive sampling. Participants will drop-out of the study if they missed >10% participation (>3 sessions out of 35 total sessions). Analysis of the effectiveness of both interventions (computer-based game and HIIT exercise) on improvement of clinical symptoms of Internet Gaming Disorder will be done using McNemar test. Meanwhile, analysis of the effectiveness of both interventions towards executive function and neuroplasticity will be done using paired-T tests. Significance levels will be set at 0.05 for analysis. All data will be analyzed using IBM SPSS v. 26.0.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One group pre and post-test design
| Arm | Type | Receives |
|---|---|---|
| Combined Intervention Group | Experimental | Behavioral: Computer-Based Game Therapy, Behavioral: High-Intensity Interval TrainingThis group will experience both computer-based game therapy and also high-intensity interval training for 7 weeks. |
Who may qualify
- Ages
- 13 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Participants who have filled and agreed to the study by signing the informed assent.
- Parents of the participants have filled and agreed to the interventions by signing the informed consent.
- Participants able to follow instruction and procedure of the study
Key exclusion criteria (5 listed)
- Physical disabilities
- Hearing disabilities
- Color blindness
- Respiratory or cardiovascular comorbidities that hinders exercise abilities
- Other psychiatric comorbidities
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 |
|---|---|---|
| Computer-Based Game TherapyComputer-based game intervention will be done three times a week, every morning before school lessons begin or during break time. Researchers will give a brief explanation of the rules on how to play the game before the intervention begins. In the game, participants will act as a fruit truck delivery driver and will have to sort out fruit delivery to different houses according to the instructions of the game. For example, the instruction starts with delivering a yellow-colored banana to a house with a red-colored roof, or delivering a purple-colored grape to a house with a blue-colored roof. Participants will first have to finish a minimum of three tutorial rounds reaching ≥75% correct delivery. Instructions will be divided into four stages; visual stimulus, auditory stimulus, visual stimulus with an obstacle, auditory stimulus with an obstacle. Each round will last for 2 minutes. Total time needed to complete a single computer-based intervention session is around 30-45 minutes. | Behavioural | Combined Intervention Group |
| High-Intensity Interval TrainingHIIT will be done two times a week during physical education hours (in the school's sports field) led by the school's physical education teacher and also certified physical trainers who have undergone training supervised by a sports medicine physician. Before the start of each HIIT session, participants will have their pulse rate assessed with a pulse oximetry and then undergo warm-up for 5 minutes. The duration of each HIIT session will be continuously extended starting at around 4 minutes (1 tabata block/8 moves) during the first week to 8 minutes (2 tabata block/16 moves) during the final week. A single tabata block moveset incorporates 8 total moves; squat jump, push up, high skipping, burpees, isometric front plank, multi jumps on bench, mountain climber in hand plank and lateral sprint (5m). Each move will be done for 20 seconds, followed by a 10 second rest. Pulse rate will be assessed again after the HIIT session and then participants will undergo cooling down and relaxation. | Behavioural | Combined Intervention Group |
Primary outcome
Clinical Symptoms
Time frame: Baseline (T0), 4th week of intervention (T1), 7th week of intervention (T2)
Clinical Symptoms of Internet Gaming Disorder evaluated with Ten-Item Internet Gaming Disorder Test (IGDT-10) questionnaire
Executive Function
Time frame: Baseline (T0), 4th week of intervention (T1), 7th week of intervention (T2)
Executive Function assessed with Behavior Rating Inventory of Executive Function (BRIEF) questionnaire
Neuroplasticity
Time frame: Baseline (T0), 4th week of intervention (T1), 7th week of intervention (T2)
Neuroplasticity measured with serum brain-derived neurotrophic factor (BDNF) levels
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- 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.
Eva Suryani, dr., Sp.KJ. principal investigator
Doctoral Program, Faculty of Medicine, Universitas Indonesia/Dr. Cipto Mangunkusumo General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer-Based Game Therapy and High-Intensity Interval Training in people with Internet Gaming Disorder, run by Universitas Indonesia at 1 site in Indonesia.
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 3 inclusion and 5 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 3 Sep 2024. 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 Indonesia. 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 Eva Suryani, dr., Sp.KJ. (+6281574877329, eva.suryanipramudhita@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Symptoms (time frame: Baseline (T0), 4th week of intervention (T1), 7th week of intervention (T2)). 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?
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 3 Sep 2024.