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

August 31, 2024 updated by: A M Y Eva Suryani, Indonesia University

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

Not yet recruiting

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

Interventional

Enrollment (Estimated)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 16, 2025

Primary Completion (Estimated)

March 6, 2025

Study Completion (Estimated)

July 21, 2025

Study Registration Dates

First Submitted

August 31, 2024

First Submitted That Met QC Criteria

August 31, 2024

First Posted (Actual)

September 3, 2024

Study Record Updates

Last Update Posted (Actual)

September 3, 2024

Last Update Submitted That Met QC Criteria

August 31, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

Clinical Trials on Internet Gaming Disorder

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