Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-03-01 @ 8:17 AM
Study NCT ID:
NCT02550405
Status:
COMPLETED
Last Update Posted:
2018-12-13
First Post:
2015-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Behavioral and Brain Mechanism of IGD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000082424', 'term': 'Internet Addiction Disorder'}], 'ancestors': [{'id': 'D000088942', 'term': 'Technology Addiction'}, {'id': 'D016739', 'term': 'Behavior, Addictive'}, {'id': 'D003192', 'term': 'Compulsive Behavior'}, {'id': 'D007175', 'term': 'Impulsive Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 204}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-12', 'studyFirstSubmitDate': '2015-09-10', 'studyFirstSubmitQcDate': '2015-09-14', 'lastUpdatePostDateStruct': {'date': '2018-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brain resting state functional connectivity as measured by fMRI', 'timeFrame': 'Detecting changes between two different time points (baseline and 6 weeks)', 'description': 'voxel-wise, ROI-wise, and ICA analyses'}, {'measure': 'Brain activation during a cue-induced craving task as measured by fMRI', 'timeFrame': 'Detecting changes between two different time points (baseline and 6 weeks)', 'description': 'A paradigm using addictive pictures to induce craving'}], 'secondaryOutcomes': [{'measure': 'Brain activation during the Cups task as measured by fMRI', 'timeFrame': 'Detecting changes between two different time points (baseline and 6 weeks)', 'description': 'Cups task measuring risky decision-making related to potential gains and losses separately'}, {'measure': 'Brain activation during the mixed gambling task tasks as measured by fMRI', 'timeFrame': 'Detecting changes between two different time points (baseline and 6 weeks)', 'description': 'The mix gambling task measuring decision-making related to loss aversion'}, {'measure': 'Brain structure as measured by structural MRI', 'timeFrame': 'Detecting changes between two different time points (baseline and 6 weeks)', 'description': 'comparing gray matter and white matter differences between individuals with IGD and healthy controls.'}, {'measure': 'IGD severity measured by Chen Internet addiction scale', 'timeFrame': 'Detecting changes between two different time points (baseline and 6 weeks)', 'description': 'a 26-item 4-point Likert scale'}, {'measure': 'Craving as measured by brief questionnaire of Internet (gaming) craving', 'timeFrame': 'Detecting changes between two different time points (baseline and 6 weeks)', 'description': 'a 8-item 7-point Likert scale'}, {'measure': 'Impulsivity as measured by Barratt impulsive scale (BIS-II)', 'timeFrame': 'Detecting changes between two different time points (baseline and 6 weeks)', 'description': 'a 30-item 4-point Likert scale'}, {'measure': 'weekly online (gaming) time', 'timeFrame': 'Detecting changes between two different time points (baseline and 6 weeks)', 'description': 'self-report,in hours'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Internet Gaming Disorder']}, 'referencesModule': {'references': [{'pmid': '25062755', 'type': 'BACKGROUND', '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.'}, {'pmid': '29740358', 'type': 'DERIVED', '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.'}, {'pmid': '28443046', 'type': 'DERIVED', '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."}]}, 'descriptionModule': {'briefSummary': 'This project aims to investigate whether anodal tDCS of dlPFC enhances cognitive regulation over craving an emotions.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inclusion criteria for IGDs were:\n\n 1. a score of 67 or higher on the CIAS;\n 2. engagement in Internet gaming for over 14 hours per week for a minimum of one year; and\n 3. reporting of Internet gaming as their primary online activity;\n* Inclusion criteria for HCs were:\n\n 1. a score \\< 60 on the CIAS;\n 2. never having spent more than 2 hours per week engaged in Internet gaming\n\nExclusion Criteria:\n\n* for all participants:\n\n 1. current or history of use of illegal substances and gambling;\n 2. current or history of psychiatric or neurological illness; and\n 3. current use of psychotropic medications'}, 'identificationModule': {'nctId': 'NCT02550405', 'briefTitle': 'The Behavioral and Brain Mechanism of IGD', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Normal University'}, 'officialTitle': 'The Behavioral and Brain Mechanism of Internet Gaming Disorder', 'orgStudyIdInfo': {'id': 'BeijingNormalU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Craving behavioral intervention', '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.', 'interventionNames': ['Behavioral: Craving behavioral intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control', '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.'}], 'interventions': [{'name': 'Craving behavioral intervention', 'type': 'BEHAVIORAL', 'otherNames': ['CBI'], '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', 'armGroupLabels': ['Craving behavioral intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100875', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'State Key Laboratory of Cognitive Neuroscience and Learning', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'XiaoYi Fang, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Institute of Developmental Psychology, Beijing Normal University'}, {'name': 'JinTao Zhang, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning'}, {'name': 'CuiCui Xia, MEd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Developmental Psychology, Beijing Normal University'}, {'name': 'LinYuan Deng, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Education Beijing Normal University'}, {'name': 'Lu Liu, BS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Developmental Psychology, Beijing Normal University'}, {'name': 'Ben Liu, BSM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning'}, {'name': 'ShanShan Ma, BS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning'}, {'name': 'YuanWei Yao, BS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning'}, {'name': 'Qinxue Liu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'School of Psychology Central China Normal University'}, {'name': 'Nan Zhou, MEd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Developmental Psychology, Beijing Normal University'}, {'name': 'ShuMeng Hou, MEd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Developmental Psychology, Beijing Normal University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Normal University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associated Professor', 'investigatorFullName': 'jintao, zhang', 'investigatorAffiliation': 'Beijing Normal University'}}}}