NCT02550405

Brief Summary

This project aims to investigate whether anodal tDCS of dlPFC enhances cognitive regulation over craving an emotions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
204

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 15, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 13, 2018

Status Verified

December 1, 2018

Enrollment Period

2.8 years

First QC Date

September 10, 2015

Last Update Submit

December 12, 2018

Conditions

Outcome Measures

Primary Outcomes (2)

  • Brain resting state functional connectivity as measured by fMRI

    voxel-wise, ROI-wise, and ICA analyses

    Detecting changes between two different time points (baseline and 6 weeks)

  • Brain activation during a cue-induced craving task as measured by fMRI

    A paradigm using addictive pictures to induce craving

    Detecting changes between two different time points (baseline and 6 weeks)

Secondary Outcomes (7)

  • Brain activation during the Cups task as measured by fMRI

    Detecting changes between two different time points (baseline and 6 weeks)

  • Brain activation during the mixed gambling task tasks as measured by fMRI

    Detecting changes between two different time points (baseline and 6 weeks)

  • Brain structure as measured by structural MRI

    Detecting changes between two different time points (baseline and 6 weeks)

  • IGD severity measured by Chen Internet addiction scale

    Detecting changes between two different time points (baseline and 6 weeks)

  • Craving as measured by brief questionnaire of Internet (gaming) craving

    Detecting changes between two different time points (baseline and 6 weeks)

  • +2 more secondary outcomes

Study Arms (2)

Craving behavioral intervention

EXPERIMENTAL

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.

Behavioral: Craving behavioral intervention

Control

NO INTERVENTION

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

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

Also known as: CBI
Craving behavioral intervention

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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;
  • a score \< 60 on the CIAS;
  • never having spent more than 2 hours per week engaged in Internet gaming

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

State Key Laboratory of Cognitive Neuroscience and Learning

Beijing, Beijing Municipality, 100875, China

Location

Related Publications (3)

  • 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: 25062755BACKGROUND
  • 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.

  • 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.

MeSH Terms

Conditions

Internet Addiction Disorder

Condition Hierarchy (Ancestors)

Technology AddictionBehavior, AddictiveCompulsive BehaviorImpulsive BehaviorBehavior

Study Officials

  • XiaoYi Fang, PhD

    Institute of Developmental Psychology, Beijing Normal University

    STUDY CHAIR
  • JinTao Zhang, PhD

    State Key Laboratory of Cognitive Neuroscience and Learning

    STUDY CHAIR
  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated Professor

Study Record Dates

First Submitted

September 10, 2015

First Posted

September 15, 2015

Study Start

March 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2015

Last Updated

December 13, 2018

Record last verified: 2018-12

Locations