A Study for the Disrupted Interpersonal Interaction Among Gaming Disorder Individuals and Treatment

January 5, 2024 updated by: Shanghai Mental Health Center

Brain Mechanism of Disrupted Interpersonal Interaction in Gaming Disorder Affecting Cognitive Control and Its Hierarchical Multidimensional Evaluation Intervention

Aiming at the major problems of unclear brain mechanism of gaming disorder and lack of effective assessment intervention tools, this project started by exploring the brain mechanism of abnormal interpersonal interaction and cognitive control deficit promoting and accelerating the development of gaming disorder, adopted a prospective cohort study design, combined with multi-modal brain functional imaging, cognitive function, social psychological assessment, and other means. To clarify the brain mechanism and outcome of gaming disorder. Based on the preliminary stage, for high-risk groups, risky gaming behavior, gaming disorder layout hierarchical multidimensional assessment intervention system, using science education, brief intervention, social psychological intervention, neural regulation, cognitive rehabilitation training, mobile medical treatment, and other ways, stratification and stage, early identification, prevention and treatment combination, accurate intervention to comprehensively reduce the occurrence and development of gaming disorder.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China
        • Recruiting
        • Shanghai Mental Health Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • (1)Clinical diagnosis of severe Gaming Disorder defined in the ICD-11; (2)Normal hearing and vision, or within normal range after correction;

Exclusion Criteria:

  • (1) Clinical diagnosis of mental health disorders other than GD defined in the ICD-11 in the past 5 years；(2) Suffering from diseases that affect cognitive function (such as cerebrovascular diseases) ; (3) Schizophrenia, bipolar disorder, depression or other Axis I disorder of DSM-V criteria;(4)any contraindication for tACS intervention.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: real tACS
Device: Transcranial Alternating Current Stimulation In recent years, transcranial alternating current stimulation (tACS) has been widely used to regulate brain neural activity and improve cognitive function because of its non-invasive, portable, and easy-to-operate characteristics. tACS can effectively improve 9 cognitive functions, including visual attention, working memory, long-term memory, executive control, fluid intelligence, learning, decision-making, motor learning, and motor memory
Device: tACS
We aim to use tACS devices to improve the disrupted interpersonal interaction among gaming disorder individuals.
Sham Comparator: sham tACS
Device: Transcranial Alternating Current Stimulation In recent years, transcranial alternating current stimulation (tACS) has been widely used to regulate brain neural activity and improve cognitive function because of its non-invasive, portable, and easy-to-operate characteristics. tACS can effectively improve 9 cognitive functions, including visual attention, working memory, long-term memory, executive control, fluid intelligence, learning, decision-making, motor learning, and motor memory
Device: tACS
We aim to use tACS devices to improve the disrupted interpersonal interaction among gaming disorder individuals.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
cue-induced craving
Time Frame: Two weeks,Four weeks
Craving was assessed by visual analog scales (VAS), with 0 mm being "no craving"and 100 mm representing "most craving ever experienced for gaming ".
Two weeks,Four weeks
inter-brain synchronization (IBS)
Time Frame: Two weeks,Four weeks
IBS was assessed by fNIRS hyperscanning with WTC analysis. A higher WTC refers to a higher level of inter-brain synchronization.
Two weeks,Four weeks
cognition measures
Time Frame: Four weeks
Chinese version of the CogState Battery was used to assess cognitive function. We selected five tasks: Two back task (working memory), Continuous paired association task (visual spatial working memory), Groton maze learning task (error monitoring), social emotional cognition (social emotional cognition) and Detection task (processing speed) which were displayed on a green screen with standardized instructions before each task beginning.The accuracy in Two back task, social emotional cognition, and the speed in Detection task, and total errors in Continuous paired association task, Groton maze learning task are our focus.
Four weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Mental Health Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 5, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 17, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 17, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NZhong-006

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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