The Behavioral and Brain Mechanism of IGD

December 12, 2018 updated by: jintao, zhang, Beijing Normal University

The Behavioral and Brain Mechanism of Internet Gaming Disorder

This project aims to investigate whether anodal tDCS of dlPFC enhances cognitive regulation over craving an emotions.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
204

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100875
        • State Key Laboratory of Cognitive Neuroscience and Learning

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Inclusion criteria for IGDs were:

    1. a score of 67 or higher on the CIAS;
    2. engagement in Internet gaming for over 14 hours per week for a minimum of one year; and
    3. reporting of Internet gaming as their primary online activity;

  • Inclusion criteria for HCs were:

    1. a score < 60 on the CIAS;
    2. never having spent more than 2 hours per week engaged in Internet gaming

Exclusion Criteria:

  • for all participants:

    1. current or history of use of illegal substances and gambling;
    2. current or history of psychiatric or neurological illness; and
    3. current use of psychotropic medications

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Craving behavioral intervention
The craving behavioral intervention (CBI) was developed based on the framework of craving, combining with behavior intervention (Dong and Potenza, 2014), and conducted among individuals with IGD.
Behavioral: Craving behavioral intervention
The CBI was given once a week for 6 weeks, conducted by four therapists. A pair of therapists was randomly assigned to a CBI+ group. Each session included 5 parts in 2.5-3 hours: warming-up exercise, discussion about the homework from the last session, main structured activity, brief summary, and the homework assignment. There were 6 sessions with each focused on a topic: recognize craving and its relationship with IGD; reduce craving through ameliorating the salience of cues and irrational beliefs, withdrawal symptoms and other negative affects; enhance self-monitoring and control for craving through time management training; relieve fulfillment of psychological needs through Internet use and attenuate the relation between craving and gaming behaviors through coping skill training
Other Names:
  • CBI
No Intervention: Control
The control group were individuals with Internet gaming disorder who did not receive any intervention but were scanned twice with the similar interval period as experimental group.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Brain resting state functional connectivity as measured by fMRI
Time Frame: Detecting changes between two different time points (baseline and 6 weeks)
voxel-wise, ROI-wise, and ICA analyses
Detecting changes between two different time points (baseline and 6 weeks)
Brain activation during a cue-induced craving task as measured by fMRI
Time Frame: Detecting changes between two different time points (baseline and 6 weeks)
A paradigm using addictive pictures to induce craving
Detecting changes between two different time points (baseline and 6 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Brain activation during the Cups task as measured by fMRI
Time Frame: Detecting changes between two different time points (baseline and 6 weeks)
Cups task measuring risky decision-making related to potential gains and losses separately
Detecting changes between two different time points (baseline and 6 weeks)
Brain activation during the mixed gambling task tasks as measured by fMRI
Time Frame: Detecting changes between two different time points (baseline and 6 weeks)
The mix gambling task measuring decision-making related to loss aversion
Detecting changes between two different time points (baseline and 6 weeks)
Brain structure as measured by structural MRI
Time Frame: Detecting changes between two different time points (baseline and 6 weeks)
comparing gray matter and white matter differences between individuals with IGD and healthy controls.
Detecting changes between two different time points (baseline and 6 weeks)
IGD severity measured by Chen Internet addiction scale
Time Frame: Detecting changes between two different time points (baseline and 6 weeks)
a 26-item 4-point Likert scale
Detecting changes between two different time points (baseline and 6 weeks)
Craving as measured by brief questionnaire of Internet (gaming) craving
Time Frame: Detecting changes between two different time points (baseline and 6 weeks)
a 8-item 7-point Likert scale
Detecting changes between two different time points (baseline and 6 weeks)
Impulsivity as measured by Barratt impulsive scale (BIS-II)
Time Frame: Detecting changes between two different time points (baseline and 6 weeks)
a 30-item 4-point Likert scale
Detecting changes between two different time points (baseline and 6 weeks)
weekly online (gaming) time
Time Frame: Detecting changes between two different time points (baseline and 6 weeks)
self-report,in hours
Detecting changes between two different time points (baseline and 6 weeks)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing Normal University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: XiaoYi Fang, PhD, Institute of Developmental Psychology, Beijing Normal University
  • Study Chair: JinTao Zhang, PhD, State Key Laboratory of Cognitive Neuroscience and Learning
  • Principal Investigator: CuiCui Xia, MEd, Institute of Developmental Psychology, Beijing Normal University
  • Principal Investigator: LinYuan Deng, PhD, Faculty of Education Beijing Normal University
  • Principal Investigator: Lu Liu, BS, Institute of Developmental Psychology, Beijing Normal University
  • Principal Investigator: Ben Liu, BSM, State Key Laboratory of Cognitive Neuroscience and Learning
  • Principal Investigator: ShanShan Ma, BS, State Key Laboratory of Cognitive Neuroscience and Learning
  • Principal Investigator: YuanWei Yao, BS, State Key Laboratory of Cognitive Neuroscience and Learning
  • Principal Investigator: Qinxue Liu, PhD, School of Psychology Central China Normal University
  • Principal Investigator: Nan Zhou, MEd, Institute of Developmental Psychology, Beijing Normal University
  • Principal Investigator: ShuMeng Hou, MEd, Institute of Developmental Psychology, Beijing Normal University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 10, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 15, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 13, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BeijingNormalU

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.

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