- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04068064
Emotional Association Bias Modification Training in Individuals With IGD
Efficacy and Mechanisms Underlying Emotional Association Bias Modification in Individuals With IGD
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Beijing
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Beijing, Beijing, China, 100875
- State Key Laboratory of Cognitive Neuroscience and Learning, Beijing Normal University
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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.
- the scores of the Young-Internet addiction Test ≥ 50
Exclusion Criteria:
- current or history of use of illegal substances and other addictions;
- current or history of psychiatric or neurological illness;
- current use of psychotropic medications.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: EABM training group
about 40 individuals with IGD will be randomly assigned to the EABM training group
|
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
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In the control group, neutral words instead of emotional words are used.
All other settings are the same with those in the intervention group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in gaming-related positive emotional association biases (EAB)
Time Frame: baseline , the 1st day after training
|
The gaming-related positive EAB will be assessed in a priming task.
In the task, participants will be instructed to judge the emotional valence of positive or negative words following gaming pictures or healthy-activity pictures.
Gaming-related positive EAB will be calculated by determining differences in reaction times (RTs; RTs (negative-word) minus RTs (positive-word)) in response to words following gaming pictures
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baseline , the 1st day after training
|
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Changes in gaming-related compulsive thoughts
Time Frame: baseline, the 1st week after training, the 2nd week after training, the 3rd week after training, the 4th week after training, the 6th week after training, the 8th week after training
|
the scores of gaming-related compulsive thoughts will be assessed with the Yale-Brown Obsessive-Compulsive Scale modified for internet gaming disorder.
The range of the score concerning gaming-related compulsive thoughts of this scale is from 0 to 20.
Higher scores means more gaming-related compulsive thoughts.
|
baseline, the 1st week after training, the 2nd week after training, the 3rd week after training, the 4th week after training, the 6th week after training, the 8th week after training
|
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Changes in gaming-related compulsive behaviors
Time Frame: baseline, the 1st week after training, the 2nd week after training, the 3rd week after training, the 4th week after training, the 6th week after training, the 8th week after training
|
the scores of gaming-related compulsive behaviors will be assessed with the Yale-Brown Obsessive-Compulsive Scale modified for internet gaming disorder.
The range of the score concerning gaming-related compulsive behaviors of this scale is from 0 to 20.
Higher scores means more gaming-related compulsive behaviors.
|
baseline, the 1st week after training, the 2nd week after training, the 3rd week after training, the 4th week after training, the 6th week after training, the 8th week after training
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in positive healthy-activity-related EAB
Time Frame: baseline and the 1st day after training
|
The healthy-activity-related positive EAB will be assessed in a priming task.
In the task, participants will be instructed to judge the emotional valence of positive or negative words following gaming pictures or healthy-activity pictures.
Healthy-activity-related positive EAB will be calculated by determining differences in reaction times (RTs; RTs (negative-word) minus RTs (positive-word)) in response to words following healthy-activity pictures
|
baseline and the 1st day after training
|
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Changes in IGD severity
Time Frame: baseline, the 4th week after training, the 8th week after training
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The scores of IGD severity will be assessed with the internet addiction test for internet gaming disorder.
The range of the score of this scale is from 20 to 100.
Higher scores means severer internet gaming disorder.
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baseline, the 4th week after training, the 8th week after training
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Changes in weekly gaming time
Time Frame: baseline, the 1st week after training, the 2nd week after training, the 3rd week after training, the 4th week after training, the 6th week after training, the 8th week after training
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weekly gaming time will be assessed by instructing participants to report weekly gaming hour in a questionaire
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baseline, the 1st week after training, the 2nd week after training, the 3rd week after training, the 4th week after training, the 6th week after training, the 8th week after training
|
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Changes in craving
Time Frame: baseline , the 1st day after training
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In the regulation-of-craving task, participants will report gaming-related craving during look condition, 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')
|
baseline , the 1st day after training
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EABMT_IGD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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