The Behavioral and Brain Mechanism of IGD
Primary Purpose
Internet Gaming Disorder
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Craving behavioral intervention
Sponsored by
About this trial
This is an interventional treatment trial for Internet Gaming Disorder
Eligibility Criteria
Inclusion Criteria:
Inclusion criteria for IGDs were:
- a score of 67 or higher on the CIAS;
- engagement in Internet gaming for over 14 hours per week for a minimum of one year; and
- reporting of Internet gaming as their primary online activity;
Inclusion criteria for HCs were:
- a score < 60 on the CIAS;
- never having spent more than 2 hours per week engaged in Internet gaming
Exclusion Criteria:
for all participants:
- current or history of use of illegal substances and gambling;
- current or history of psychiatric or neurological illness; and
- current use of psychotropic medications
Sites / Locations
- State Key Laboratory of Cognitive Neuroscience and Learning
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Craving behavioral intervention
Control
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Brain resting state functional connectivity as measured by fMRI
voxel-wise, ROI-wise, and ICA analyses
Brain activation during a cue-induced craving task as measured by fMRI
A paradigm using addictive pictures to induce craving
Secondary Outcome Measures
Brain activation during the Cups task as measured by fMRI
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
The mix gambling task measuring decision-making related to loss aversion
Brain structure as measured by structural MRI
comparing gray matter and white matter differences between individuals with IGD and healthy controls.
IGD severity measured by Chen Internet addiction scale
a 26-item 4-point Likert scale
Craving as measured by brief questionnaire of Internet (gaming) craving
a 8-item 7-point Likert scale
Impulsivity as measured by Barratt impulsive scale (BIS-II)
a 30-item 4-point Likert scale
weekly online (gaming) time
self-report,in hours
Full Information
NCT ID
NCT02550405
First Posted
September 10, 2015
Last Updated
December 12, 2018
Sponsor
Beijing Normal University
1. Study Identification
Unique Protocol Identification Number
NCT02550405
Brief Title
The Behavioral and Brain Mechanism of IGD
Official Title
The Behavioral and Brain Mechanism of Internet Gaming Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Normal University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This project aims to investigate whether anodal tDCS of dlPFC enhances cognitive regulation over craving an emotions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Internet Gaming Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
204 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Craving behavioral intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Craving behavioral intervention
Other Intervention Name(s)
CBI
Intervention Description
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
Primary Outcome Measure Information:
Title
Brain resting state functional connectivity as measured by fMRI
Description
voxel-wise, ROI-wise, and ICA analyses
Time Frame
Detecting changes between two different time points (baseline and 6 weeks)
Title
Brain activation during a cue-induced craving task as measured by fMRI
Description
A paradigm using addictive pictures to induce craving
Time Frame
Detecting changes between two different time points (baseline and 6 weeks)
Secondary Outcome Measure Information:
Title
Brain activation during the Cups task as measured by fMRI
Description
Cups task measuring risky decision-making related to potential gains and losses separately
Time Frame
Detecting changes between two different time points (baseline and 6 weeks)
Title
Brain activation during the mixed gambling task tasks as measured by fMRI
Description
The mix gambling task measuring decision-making related to loss aversion
Time Frame
Detecting changes between two different time points (baseline and 6 weeks)
Title
Brain structure as measured by structural MRI
Description
comparing gray matter and white matter differences between individuals with IGD and healthy controls.
Time Frame
Detecting changes between two different time points (baseline and 6 weeks)
Title
IGD severity measured by Chen Internet addiction scale
Description
a 26-item 4-point Likert scale
Time Frame
Detecting changes between two different time points (baseline and 6 weeks)
Title
Craving as measured by brief questionnaire of Internet (gaming) craving
Description
a 8-item 7-point Likert scale
Time Frame
Detecting changes between two different time points (baseline and 6 weeks)
Title
Impulsivity as measured by Barratt impulsive scale (BIS-II)
Description
a 30-item 4-point Likert scale
Time Frame
Detecting changes between two different time points (baseline and 6 weeks)
Title
weekly online (gaming) time
Description
self-report,in hours
Time Frame
Detecting changes between two different time points (baseline and 6 weeks)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Inclusion criteria for IGDs were:
a score of 67 or higher on the CIAS;
engagement in Internet gaming for over 14 hours per week for a minimum of one year; and
reporting of Internet gaming as their primary online activity;
Inclusion criteria for HCs were:
a score < 60 on the CIAS;
never having spent more than 2 hours per week engaged in Internet gaming
Exclusion Criteria:
for all participants:
current or history of use of illegal substances and gambling;
current or history of psychiatric or neurological illness; and
current use of psychotropic medications
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
XiaoYi Fang, PhD
Organizational Affiliation
Institute of Developmental Psychology, Beijing Normal University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
JinTao Zhang, PhD
Organizational Affiliation
State Key Laboratory of Cognitive Neuroscience and Learning
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
CuiCui Xia, MEd
Organizational Affiliation
Institute of Developmental Psychology, Beijing Normal University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
LinYuan Deng, PhD
Organizational Affiliation
Faculty of Education Beijing Normal University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lu Liu, BS
Organizational Affiliation
Institute of Developmental Psychology, Beijing Normal University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ben Liu, BSM
Organizational Affiliation
State Key Laboratory of Cognitive Neuroscience and Learning
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
ShanShan Ma, BS
Organizational Affiliation
State Key Laboratory of Cognitive Neuroscience and Learning
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
YuanWei Yao, BS
Organizational Affiliation
State Key Laboratory of Cognitive Neuroscience and Learning
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Qinxue Liu, PhD
Organizational Affiliation
School of Psychology Central China Normal University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nan Zhou, MEd
Organizational Affiliation
Institute of Developmental Psychology, Beijing Normal University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
ShuMeng Hou, MEd
Organizational Affiliation
Institute of Developmental Psychology, Beijing Normal University
Official's Role
Principal Investigator
Facility Information:
Facility Name
State Key Laboratory of Cognitive Neuroscience and Learning
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100875
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
25062755
Citation
Dong G, Potenza MN. A cognitive-behavioral model of Internet gaming disorder: theoretical underpinnings and clinical implications. J Psychiatr Res. 2014 Nov;58:7-11. doi: 10.1016/j.jpsychires.2014.07.005. Epub 2014 Jul 17.
Results Reference
background
PubMed Identifier
29740358
Citation
Liu L, Yao YW, Li CR, Zhang JT, Xia CC, Lan J, Ma SS, Zhou N, Fang XY. The Comorbidity Between Internet Gaming Disorder and Depression: Interrelationship and Neural Mechanisms. Front Psychiatry. 2018 Apr 23;9:154. doi: 10.3389/fpsyt.2018.00154. eCollection 2018.
Results Reference
derived
PubMed Identifier
28443046
Citation
Deng LY, Liu L, Xia CC, Lan J, Zhang JT, Fang XY. Craving Behavior Intervention in Ameliorating College Students' Internet Game Disorder: A Longitudinal Study. Front Psychol. 2017 Apr 10;8:526. doi: 10.3389/fpsyg.2017.00526. eCollection 2017.
Results Reference
derived
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The Behavioral and Brain Mechanism of IGD
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