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Neurofeedback for Internet Gaming Addiction

Primary Purpose

Internet Gaming Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Neurofeedback training
Sham feedback training
Sponsored by
University of Macau
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Internet Gaming Disorder focused on measuring neurofeedback, behavior addiction

Eligibility Criteria

18 Years - 28 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Meet at least five of the Diagnostic and Statistical Manual of Mental Disorders fifth edition (DSM-5) criteria for IGD and score 38 or above on the Internet Addiction Test (IAT) First language is Chinese (Mandarin) Right-handed Have played the mobile game "King of Glory" for more than 3 years Ability to give informed consent Normal or corrected-to-normal vision Exclusion Criteria: Any primary diagnosis of a current psychological or neurological disorder Any history of psychological or neurological disorder Any MRI contraindication Currently on a psychotropic medication Any history of substance dependence Any history of brain injury or surgery

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Experimental neurofeedback intervention

    Sham feedback intervention

    Arm Description

    In an approximately 30-minute training session, participants receive activity feedback from a midbrain region involved in reward processing and gaming addiction. Feedback will be presented in the form of a thermometer/bar in the middle of the screen and updated every two seconds. They will be trained to down-regulate the activity in this region with the help of this feedback using cognitive strategies. This down-regulation training is believed to be beneficial to addictive behaviors by the investigators.

    In an approximately 30-minute training session, participants receive activity feedback from a brain region irrelevant to reward processing or gaming addictive behavior. The feedback presentation form and task instructions will be the same as for the experimental group. Based on the functional role of the feedback region, the investigators do not believe this feedback training will change the addictive behaviors of the participants who receive this intervention.

    Outcomes

    Primary Outcome Measures

    Change from Baseline in self-reported urge for internet gaming as assessed by Visual Analog Scales (1 to 100)

    Secondary Outcome Measures

    Change in reward-related activity during exposure to internet gaming videos
    Participants will complete cue-reactivity tasks in which they are exposed to video clips captured from the dependent mobile game before and after the intervention. Functional MRI data will be collected to measure their pre- to post-intervention changes in the brain reward processing pathways.
    Change in inhibitory response in the affective Go/Nogo task
    This task that uses affective Chinese characters as stimuli will be used to examine changes in inhibitory control performance as well as changes in brain activity associated with this cognitive process pre- to post-intervention.

    Full Information

    First Posted
    May 31, 2023
    Last Updated
    September 29, 2023
    Sponsor
    University of Macau
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06063642
    Brief Title
    Neurofeedback for Internet Gaming Addiction
    Official Title
    Real-time Functional Magnetic Resonance Imaging Neurofeedback Treatment for Young Adults With Internet Gaming Addiction
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 15, 2023 (Anticipated)
    Primary Completion Date
    April 20, 2024 (Anticipated)
    Study Completion Date
    June 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Macau

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The primary aim of this study is to evaluate the therapeutic potential of real-time functional magnetic resonance imaging (MRI) neurofeedback in alleviating internet gaming disorder (IGD) symptoms by training individuals with such symptoms to down-regulate the activity in their reward-processing-related midbrain regions.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Internet Gaming Disorder
    Keywords
    neurofeedback, behavior addiction

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Eligible candidates will be randomly assigned to either receive the experimental feedback intervention or sham feedback intervention.
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    All participants will be blind to the intervention group assignment until they complete the entire study procedure. An outcome assessor who is blind to this assignment will collect the primary outcome measurement data.
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental neurofeedback intervention
    Arm Type
    Experimental
    Arm Description
    In an approximately 30-minute training session, participants receive activity feedback from a midbrain region involved in reward processing and gaming addiction. Feedback will be presented in the form of a thermometer/bar in the middle of the screen and updated every two seconds. They will be trained to down-regulate the activity in this region with the help of this feedback using cognitive strategies. This down-regulation training is believed to be beneficial to addictive behaviors by the investigators.
    Arm Title
    Sham feedback intervention
    Arm Type
    Sham Comparator
    Arm Description
    In an approximately 30-minute training session, participants receive activity feedback from a brain region irrelevant to reward processing or gaming addictive behavior. The feedback presentation form and task instructions will be the same as for the experimental group. Based on the functional role of the feedback region, the investigators do not believe this feedback training will change the addictive behaviors of the participants who receive this intervention.
    Intervention Type
    Device
    Intervention Name(s)
    Neurofeedback training
    Intervention Description
    Neurofeedback training is a type of non-invasive brain modulation technique that enables individuals to self-regulate brain activity patterns by providing them feedback on specific activity measures. Effective self-regulation is often linked to changes in cognition, behavior, and clinical symptoms.
    Intervention Type
    Device
    Intervention Name(s)
    Sham feedback training
    Intervention Description
    A controlled form of neurofeedback training that provides feedback irrelevant to the targeted mental process.
    Primary Outcome Measure Information:
    Title
    Change from Baseline in self-reported urge for internet gaming as assessed by Visual Analog Scales (1 to 100)
    Time Frame
    Up to 30 days after the intervention session
    Secondary Outcome Measure Information:
    Title
    Change in reward-related activity during exposure to internet gaming videos
    Description
    Participants will complete cue-reactivity tasks in which they are exposed to video clips captured from the dependent mobile game before and after the intervention. Functional MRI data will be collected to measure their pre- to post-intervention changes in the brain reward processing pathways.
    Time Frame
    Up to 3 days
    Title
    Change in inhibitory response in the affective Go/Nogo task
    Description
    This task that uses affective Chinese characters as stimuli will be used to examine changes in inhibitory control performance as well as changes in brain activity associated with this cognitive process pre- to post-intervention.
    Time Frame
    Up to 3 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    28 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Meet at least five of the Diagnostic and Statistical Manual of Mental Disorders fifth edition (DSM-5) criteria for IGD and score 38 or above on the Internet Addiction Test (IAT) First language is Chinese (Mandarin) Right-handed Have played the mobile game "King of Glory" for more than 3 years Ability to give informed consent Normal or corrected-to-normal vision Exclusion Criteria: Any primary diagnosis of a current psychological or neurological disorder Any history of psychological or neurological disorder Any MRI contraindication Currently on a psychotropic medication Any history of substance dependence Any history of brain injury or surgery
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zhiying Zhao, Ph.D
    Phone
    (853) 8822 9182
    Email
    zhiyingzhao@um.edu.mo
    First Name & Middle Initial & Last Name or Official Title & Degree
    Anqi Gu, B.S.
    Email
    mc25783@connect.um.edu.mo

    12. IPD Sharing Statement

    Learn more about this trial

    Neurofeedback for Internet Gaming Addiction

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