Clinical trial NCT06582979: Effect of Computer-Based Game and HIIT Towards Symptoms, Executive Function and Neuroplasticity in Teens with IGD
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Internet Gaming Disorder
Keywords: Indonesia
Computer-based game
High-Intensity Interval Training
Executive Function
Neuroplasticity
Adolescents
Internet Gaming Disorder
Study protocol
Teens
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2024-09-03
Enrollment: 44
Sex: ALL
Minimum age (years): 13
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: One group pre and post-test design
Primary purpose: TREATMENT

Brief 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). 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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical Symptoms
timeFrame: Baseline (T0), 4th week of intervention (T1), 7th week of intervention (T2)
measure: Executive Function
timeFrame: Baseline (T0), 4th week of intervention (T1), 7th week of intervention (T2)
measure: Neuroplasticity
timeFrame: Baseline (T0), 4th week of intervention (T1), 7th week of intervention (T2)
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Faculty of Medicine, Universitas Indonesia - Dr. Cipto Mangunkusumo General Hospital
state: DKI Jakarta
Study officials:
affiliation: Doctoral Program, Faculty of Medicine, Universitas Indonesia/Dr. Cipto Mangunkusumo General Hospital
name: Eva Suryani, dr., Sp.KJ.
role: PRINCIPAL_INVESTIGATOR
References: