NCT06582979

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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 3, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

January 16, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2025

Completed
Last Updated

September 3, 2024

Status Verified

August 1, 2024

Enrollment Period

2 months

First QC Date

August 31, 2024

Last Update Submit

August 31, 2024

Conditions

Keywords

IndonesiaComputer-based gameHigh-Intensity Interval TrainingExecutive FunctionNeuroplasticityAdolescentsInternet Gaming DisorderStudy protocolTeens

Outcome Measures

Primary Outcomes (3)

  • Clinical Symptoms

    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

    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

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

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

Study Arms (1)

Combined Intervention Group

EXPERIMENTAL

This group will experience both computer-based game therapy and also high-intensity interval training for 7 weeks.

Behavioral: Computer-Based Game TherapyBehavioral: High-Intensity Interval Training

Interventions

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.

Combined Intervention Group

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.

Combined Intervention Group

Eligibility Criteria

Age13 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Jakarta, DKI Jakarta, Indonesia

Location

MeSH Terms

Conditions

Internet Addiction Disorder

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Technology AddictionBehavior, AddictiveCompulsive BehaviorImpulsive BehaviorBehavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Eva Suryani, dr., Sp.KJ.

    Doctoral Program, Faculty of Medicine, Universitas Indonesia/Dr. Cipto Mangunkusumo General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eva Suryani, dr., Sp.KJ.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: One group pre and post-test design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Eva Suryani, dr., Sp.KJ

Study Record Dates

First Submitted

August 31, 2024

First Posted

September 3, 2024

Study Start

January 16, 2025

Primary Completion

March 6, 2025

Study Completion

July 21, 2025

Last Updated

September 3, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations