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Emotional Association Bias Modification Training in Individuals With IGD

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ClinicalTrials.gov Identifier: NCT04068064
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : December 26, 2019
Sponsor:
Information provided by (Responsible Party):
Jin-tao Zhang, Beijing Normal University

Brief Summary:
This project aims to investigate (1) the efficacy of emotional association bias modification (EABM) training on internet gaming disorder (IGD); (2) the underlying neural mechanisms of such efficacy

Condition or disease Intervention/treatment Phase
Internet Gaming Disorder Procedure: EABM training Procedure: sham training Not Applicable

Detailed Description:

As with the efficacy, the experiment aims to test whether EABM training will reduce positive emotional association bias towards gaming, compulsive choice of gaming pictures, cue-induced craving for gaming, the severity of gaming behaviors in individuals with IGD.

As with the underlying neural mechanisms, the experiment aims to test whether EABM training will alter the activation of reward circuits in response to gaming pictures, the activation of executive control network (mainly refering to the prefrontal cortex) regarding regulation ability for craving and response inhibition ability.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: a randomized, between-subject design, including an intervention group and a control group
Masking: Double (Participant, Investigator)
Masking Description: the grouping is blind to both participants and the investigator
Primary Purpose: Basic Science
Official Title: Efficacy and Mechanisms Underlying Emotional Association Bias Modification in Individuals With IGD
Actual Study Start Date : August 23, 2019
Estimated Primary Completion Date : January 30, 2020
Estimated Study Completion Date : March 28, 2020

Arm Intervention/treatment
Experimental: EABM training group
about 40 individuals with IGD will be randomly assigned to the EABM training group
Procedure: EABM training

The training aims at associating gaming pictures with negative words and pictures of healthy activities with positive words. Gaming pictures are always presented with a pair of negative words. Pictures of healthy activities are always presented with a pair of positive words. Each picture is presented with a fixed pair of words. Participants will be instructed to select one word to get the most monetary reward. Specifically, in response to each gaming picture, selecting one word will have a 70% chance to get a monetary reward and the other word will have a 30% chance to get a monetary reward. A similar rationale applies to the pictures of healthy activities. The reward setting will help consolidate target associations.

Each training session includes 300 times/trials of each type of association, presented in pseudorandom way. The whole training includes 6 training sessions. Participants will receive one training session every days.


Placebo Comparator: Control training group
about another 40 individuals with IGD will be randomly assigned to the control training group
Procedure: sham training
In the control group, neutral words instead of emotional words are used. All other settings are the same with those in the intervention group




Primary Outcome Measures :
  1. Changes in gaming time [ Time Frame: baseline , one day after training, one month after training, and two months after training ]
    The average time of gaming behaviors per week

  2. Changes in regulation tendencies with respect to gaming-related craving [ Time Frame: baseline and 1 day after training ]
    In the ROC (regulation of craving) task, participants will report gaming-related craving during look condtion, and during regulation condition using cognitive reappraisal,respectively. Craving will be assessed using a Visual Analog Scale (from 1 = 'not at all' to 9 = 'very high')


Secondary Outcome Measures :
  1. Changes in gaming-related compulsivity [ Time Frame: baseline and 1 day after training ]
    Continuous choice of gaming pictures will be assessed in the Choice task

  2. Changes in activation of an executive control network regarding regulation ability for gaming-related craving [ Time Frame: baseline and 1 day after training ]
    In the ROC task, in the regulation condition, participants will downregulate gaming-related craving and upregulate craving for non-gaming activities, respectively, using cognitive reappraisal during fMRI (functional magnetic resonance imaging). Brain responses relating to these regulation processes will be assessed

  3. Changes in positive association bias towards gaming cues [ Time Frame: baseline and 1 day after training ]
    Positive association biases towards gaming cues will be assessed in a sequential priming task

  4. Changes in severity of IGD [ Time Frame: baseline , and one month after training ]
    Scores on Young's internet addiction test will be assessed before training, and one month after training. This scale tests severity of internet addiction, with higher total scores representing more severe addictive tendencies. The scale range is 20-100, with 50-60 corresponding to mild severity, 60-80 corresponding to moderate severity, with 80-100 corresponding to high severity.

  5. Changes in activation of an executive control network with respect to gaming-related response inhibition [ Time Frame: baseline and 1 day after training ]
    Participants will complete a gaming-related Go/Nogo task during fMRI. Brain responses relating to such response inhibition will be assessed.



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. the 5th edition of Diagnostic and Statistical Manual of Mental Disorders (DSM-5 ) recommended diagnosis of Internet gaming disorder :

    the scores of the 9 items of DSM-5 recommended diagnosis for Internet gaming disorder ≥ 5.

    engagement in popular Internet games (e.g. Arena of Valor, League of Legends and Player Unknown's Battle Grounds) for over 20 hours per week for a minimum of 12 months.

  2. the scores of the Young-Internet addiction Test ≥ 50

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04068064


Contacts
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Contact: Lulu Wu, Master +8615910375909 994970236@qq.com
Contact: Jintao Zhang, phD +8610 58800728 zhangjintao@bnu.edu.cn

Locations
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China, Beijing
State Key Laboratory of Cognitive Neuroscience and Learning, Beijing Normal University Recruiting
Beijing, Beijing, China, 100875
Contact: Jin-Tao Zhang, phD    +861058800728    zhangjintao@bnu.edu.cn   
Sponsors and Collaborators
Beijing Normal University
Investigators
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Principal Investigator: Jintao Zhang, phD Beijing Normal University
Publications:
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Responsible Party: Jin-tao Zhang, Professor, Beijing Normal University
ClinicalTrials.gov Identifier: NCT04068064    
Other Study ID Numbers: EABMT_IGD
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: December 26, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: we will share individual participant data when required
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: 1 year after the publication of related paper , for 3 years
Access Criteria: By contacting the principal investigator. Email : zhangjintao@bnu.edu.cn

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No