- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06582979
Effect of Computer-Based Game and HIIT Towards Symptoms, Executive Function and Neuroplasticity in Teens with IGD
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?
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)
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Eva Suryani, dr., Sp.KJ.
- Phone Number: +6281574877329
- Email: eva.suryanipramudhita@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Physical disabilities
- Hearing disabilities
- Color blindness
- Respiratory or cardiovascular comorbidities that hinders exercise abilities
- Other psychiatric comorbidities
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Baseline (T0), 4th week of intervention (T1), 7th week of intervention (T2)
|
|
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
|
Baseline (T0), 4th week of intervention (T1), 7th week of intervention (T2)
|
|
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
|
Baseline (T0), 4th week of intervention (T1), 7th week of intervention (T2)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24-03-0436
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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