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NCT Number: NCT06582979

Effect of Computer-Based Game and HIIT Towards Symptoms, Executive Function and Neuroplasticity in Teens with IGD

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)

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Key information

Age range

13 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, Universitas Indonesia - Dr. Cipto Mangunkusumo General Hospital

Jakarta, DKI Jakarta, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Computer-Based Game Therapy

Behavioral

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 training

Behavioral

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Eva Suryani, dr., Sp.KJ.

CONTACT

[email protected]

+6281574877329

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 3, 2024
Registry last updated
Sep 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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