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The Behavioral and Brain Mechanism of IGD

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ClinicalTrials.gov Identifier: NCT02550405
Recruitment Status : Completed
First Posted : September 15, 2015
Last Update Posted : December 13, 2018
Sponsor:
Information provided by (Responsible Party):
jintao, zhang, Beijing Normal University

Tracking Information
First Submitted Date  ICMJE September 10, 2015
First Posted Date  ICMJE September 15, 2015
Last Update Posted Date December 13, 2018
Study Start Date  ICMJE March 2012
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2015)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2015)
  • 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
  • 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
  • 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.
  • 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
  • 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
  • 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
  • weekly online (gaming) time [ Time Frame: Detecting changes between two different time points (baseline and 6 weeks) ]
    self-report,in hours
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Behavioral and Brain Mechanism of IGD
Official Title  ICMJE The Behavioral and Brain Mechanism of Internet Gaming Disorder
Brief Summary This project aims to investigate whether anodal tDCS of dlPFC enhances cognitive regulation over craving an emotions.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Internet Gaming Disorder
Intervention  ICMJE 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 Name: CBI
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Craving behavioral intervention
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 14, 2015)
204
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 30 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02550405
Other Study ID Numbers  ICMJE BeijingNormalU
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party jintao, zhang, Beijing Normal University
Study Sponsor  ICMJE Beijing Normal University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Beijing Normal University
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP