NCT04110548

Brief Summary

To investigate the potential deficits in emotion and craving regulation capacities of drug-naïve young adults with Internet gaming disorder as compared with healthy controls.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

September 26, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2020

Completed
Last Updated

January 27, 2021

Status Verified

January 1, 2021

Enrollment Period

6 months

First QC Date

September 23, 2019

Last Update Submit

January 25, 2021

Conditions

Internet Gaming DisorderEmotion Regulation

Keywords

Emotion and craving regulation

Outcome Measures

Primary Outcomes (3)

  • Behavioral outcome

    Participants' ratings of negative emotion and their skin conductance levels (SCL).

    30- 40 minutes after training

  • Behavioral outcome

    Participants' ratings of negative emotion and their skin conductance levels (SCL).

    40- 60 minutes after training

  • Behavioral outcome

    Participants' ratings of cravings and their skin conductance levels (SCL).

    60- 80 minutes after training

Study Arms (3)

HCs on Emotion Regulation

EXPERIMENTAL

Participants are screened using the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5), Young's online Internet addiction test (YIAT), Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), and so on. They are instructed to complete the emotion regulation task on the computer.

Procedure: Emotion Regulation Task

IGDs on Emotion Regulation

EXPERIMENTAL

Participants are screened using the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5), Young's online Internet addiction test (YIAT), Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), and so on.They are instructed to complete the emotion regulation task on the computer.

Procedure: Emotion Regulation Task

IGDs on Craving Regulation

EXPERIMENTAL

Participants are screened using the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5), Young's online Internet addiction test (YIAT), Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), and so on. They are instructed to complete the craving regulation task on the computer.

Procedure: Craving Regulation Task

Interventions

Emotion Regulation TaskPROCEDURE

Participants are instructed to complete the emotion assessment after Look or Decrease the neutral or negative pictures. The "Decrease" asks the participants to use "cognitive reappraisal" or "mindfulness" strategies to decrease the intensity of emotion, whereas the "Look" asks the participants to look naturally at the picture. First, the "look" or "decrease" is displayed on the computer for 2 s. Then, a neutral or negative picture is presented on the screen for 7s. Finally, participants will rate the intensity of their emotion for 4s. Then, they have 1s-3s to relax before the next trial. In the meantime, Skin conductance activities will be recorded using a constant voltage with 1-cm 3 AgAg/Cl electrodes attached to the medial phalanx surfaces of the middle and index fingers of the nondominant hand.

HCs on Emotion RegulationIGDs on Emotion Regulation
Craving Regulation TaskPROCEDURE

Participants are instructed to complete the craving assessment after Look or Decrease the neutral or gaming pictures. The "Decrease" asks the participants to use "cognitive reappraisal" or "mindfulness" strategies to decrease the intensity of craving, whereas the "Look" asks the participants to look naturally at the picture. First, the "look" or "decrease" is displayed on the computer for 2 s. Second, a neutral or gaming picture is presented on the screen for 7s. Third, participants rate the intensity of their craving for 4s. Then, they have 1s-3s to relax before the next trial. In the meantime, Skin conductance activities will be recorded using a constant voltage with 1-cm 3 AgAg/Cl electrodes attached to the medial phalanx surfaces of the middle and index fingers of the nondominant hand.

IGDs on Craving Regulation

Eligibility Criteria

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

You may qualify if:

  • Internet gaming disorders (IGD):
  • , 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 Y-IAT(Young-Internet addiction Test) ≥ 50
  • Healthy controls (HCs): DSM-5 scores less than 5 and less than 20 hours gaming time per week.

You may not qualify if:

  • current or history of use of illegal substances and gambling; current or history of psychiatric or neurological illness; current use of psychotropic medications; being left-handed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Normal University

Beijing, Beijing Municipality, 100875, China

Location

Related Publications (2)

  • Yip SW, Gross JJ, Chawla M, Ma SS, Shi XH, Liu L, Yao YW, Zhu L, Worhunsky PD, Zhang J. Is Neural Processing of Negative Stimuli Altered in Addiction Independent of Drug Effects? Findings From Drug-Naive Youth with Internet Gaming Disorder. Neuropsychopharmacology. 2018 May;43(6):1364-1372. doi: 10.1038/npp.2017.283. Epub 2017 Nov 20.

    PMID: 29154365BACKGROUND

  • Westbrook C, Creswell JD, Tabibnia G, Julson E, Kober H, Tindle HA. Mindful attention reduces neural and self-reported cue-induced craving in smokers. Soc Cogn Affect Neurosci. 2013 Jan;8(1):73-84. doi: 10.1093/scan/nsr076. Epub 2011 Nov 22.

    PMID: 22114078BACKGROUND

MeSH Terms

Conditions

Internet Addiction DisorderEmotional Regulation

Condition Hierarchy (Ancestors)

Technology AddictionBehavior, AddictiveCompulsive BehaviorImpulsive BehaviorBehaviorSelf-ControlSocial Behavior

Study Officials

  • Nan Zhou, PhD

    Beijing Normal University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 23, 2019

First Posted

October 1, 2019

Study Start

September 26, 2019

Primary Completion

March 30, 2020

Study Completion

May 30, 2020

Last Updated

January 27, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)