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临床试验/NCT06582979
NCT06582979尚未招募不适用

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

Indonesia University1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2025年1月16日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
44
试验地点
1
主要终点
Clinical Symptoms

研究概览

简要总结

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)

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
13 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Physical disabilities
  • Hearing disabilities
  • Color blindness
  • Respiratory or cardiovascular comorbidities that hinders exercise abilities
  • Other psychiatric comorbidities

结局指标

主要结局

Clinical Symptoms

时间窗: 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

时间窗: 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

时间窗: Baseline (T0), 4th week of intervention (T1), 7th week of intervention (T2)

Neuroplasticity measured with serum brain-derived neurotrophic factor (BDNF) levels

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

A M Y Eva Suryani

Eva Suryani, dr., Sp.KJ

Indonesia University

研究点 (1)

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