NCT07843615

Brief Summary

Addressing the three core issues in research on cognitive control deficits in Internet Gaming Disorder (IGD)-unclear neural mechanisms, limited intervention targets, and poor patient compliance-this project innovatively constructs a pathological model of IGD characterized by "decline in social rewards → dysfunction of the dorsal Anterior Cingulate Cortex-Dorsolateral Prefrontal Cortex (dACC-DLPFC) cognitive control circuit → abnormalities in the frontal midline theta rhythm (Fmθ)." The investigators have developed a dual-target intervention system that integrates neurofeedback with social reward substitution, transforming social rewards into therapeutic reinforcers to enhance the effectiveness of the intervention.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
27mo left

Started Jan 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress25%
Jan 2026Dec 2028

Study Start

First participant enrolled

January 1, 2026

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 28, 2026

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2028

Last Updated

September 28, 2026

Status Verified

June 1, 2026

Enrollment Period

3 years

First QC Date

July 20, 2026

Last Update Submit

September 25, 2026

Conditions

Keywords

Internet Gaming DisorderCognitive ControlRestructuring of the dACC-DLPFC LoopSocial RewardsNeurofeedback Therapy

Outcome Measures

Primary Outcomes (9)

  • Severity of Gaming Disorder

    The severity of gaming disorder was assessed using the Gaming Disorder Screening Scale (GDSS), which consists of 18 Likert-scale items. Each item has four response options (1 = never; 2 = sometimes; 3 = often; 4 = always), with a total score range of 18 to 72. Based on receiver operating characteristic (ROC) analysis using ICD-11 as the gold standard, a total score of ≥47 indicates a high risk of gaming disorder

    through neurofeedback training completion, an average of 1 month

  • Results of Neurofeedback Training

    Results of Neurofeedback Training:Average increase in frontal midline theta (Fmθ) power during training. The higher the power, the better theresults

    through neurofeedback training completion, an average of 1 month

  • Results of Neurofeedback Training

    Results of Neurofeedback Training:The time it takes for participants to reach a predetermined target energy level. The shorter the time, the better the training results.

    through neurofeedback training completion, an average of 1 month

  • Changes of Behavioral Indicators

    Stop-Signal Reaction Time (SSRT) derived from the Social Reward-modified Stop-Signal Task. Shorter SSRT indicates better cognitive control performance under social-reward versus no-reward conditions.

    through neurofeedback training completion, an average of 1 month

  • Changes of Behavioral Indicators

    Stop-Signal Delay (SSD) derived from the Social Reward-modified Stop-Signal Task. Higher SSD indicates better cognitive control performance under social-reward versus no-reward conditions.

    through neurofeedback training completion, an average of 1 month

  • Changes of Behavioral Indicators

    Hit rate derived from the Social Incentive Delay Task. Reduced hit rate under social-reward cue conditions indicates impaired social reward processing.

    through neurofeedback training completion, an average of 1 month

  • Changes of Behavioral Indicators

    Reaction time for correct hits derived from the Social Incentive Delay Task. Prolonged reaction time under social-reward cue conditions indicates impaired social reward processing.

    through neurofeedback training completion, an average of 1 month

  • Social Reward

    The social reward function was measured using the "Social Pleasure" subscale of the Multidimensional Pleasure Deficit Scale. This subscale consists of four items. Participants were first asked to list two current or past social activities that had brought them pleasure, and then to respond to each item, assessing factors such as their willingness to participate in these activities and the level of pleasure experienced during participation. Scoring is based on a 10-point Likert scale, ranging from "Not at all" to "Very much." Higher scores indicate stronger social reward.

    through neurofeedback training completion, an average of 1 month

  • Executive Function

    Executive function was evaluated using the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A), comprising 75 items scored on a 3-point Likert scale ranging from "never" to "often." Higher scores on the Global Executive Composite (GEC) reflect greater executive function impairment.

    through neurofeedback training completion, an average of 1 month

Secondary Outcomes (3)

  • Changes of Electrophysiological Indicators

    through neurofeedback training completion, an average of 1 month

  • Changes of Electrophysiological Indicators

    through neurofeedback training completion, an average of 1 month

  • Neuroimaging Indicators

    through neurofeedback training completion, an average of 1 month

Study Arms (3)

Dual-regulation group

EXPERIMENTAL

1. Conduct a single-blind, randomized controlled trial. 40 participants assigned to the dual-regulation group will receive a full course of "neural circuit activation + social reward promotion" dual neurofeedback training. 2. Assessments, including standardized scales, behavioral tests, and neuroimaging, will be conducted once before and once after the intervention. 3. During neurofeedback training, participants will undergo training four times per week, for a total of 16 sessions. 4. The entire intervention will last approximately one month. To track the immediacy and sustainability of the intervention's effects, the above measures will be collected at all four time points:baseline (T0, Time Point 0), immediately post-intervention (T1, Time Point 1), 6-month follow-up (T2, Time Point 2) and 12-month (T3, Time Point 3) follow-ups.

Behavioral: "Activate Neural Circuits + Promote Social Rewards" Dual-target Neurofeedback Training

Single-regulation group( Neural Circuits Activation Only )

OTHER

1. Conduct a single-blind, randomized controlled trial. The 40 participants assigned to the single-regulation group will receive only "inhibitory" neurofeedback training targeting the dACC-DLPFC (dorsal Anterior Cingulate Cortex - Dorsolateral Prefronteral Prefronta Cortex) circuit (activating the neural circuit only, without promoting social reward). 2. Assessments will include standardized scales, behavioral tests, and neuroimaging, each administered once before and after the intervention. 3. During neurofeedback training, participants will undergo training four times per week, for a total of 16 sessions. 4. The entire intervention will last approximately one month. To track the immediacy and sustainability of the intervention's effects, the above measures will be collected at all four time points: baseline (T0), immediately post-intervention (T1), and at 6-month (T2) and 12-month (T3) follow-ups.

Behavioral: "Activate Only the Neural Circuits" Neurofeedback Training

Sham Feedback group (none contingent feedback)

OTHER

1. Conduct a single-blind, randomized controlled trial. The 40 participants assigned to the sham feedback group will follow the same task protocol but receive sham feedback unrelated to their own brain activity. 2. Assessments, including standardized scales, behavioral tests, and neuroimaging, will be conducted once before and once after the intervention. 3. During neurofeedback training, participants will undergo training four times per week, for a total of 16 sessions. 4. The entire intervention will last approximately one month. To track the immediacy and sustainability of the intervention's effects, the above measures will be collected at all four time points: baseline (T0), immediately post-intervention (T1), and at 6-month (T2) and 12-month (T3) follow-ups.

Behavioral: Sham Feedback

Interventions

Using the MATLAB environment, the PsychToolbox add-on, and the integrated EEGLAB toolbox for real-time EEG signal processing, a neural feedback system was constructed to enable precise, targeted regulation of the dACC-DLPFC circuit. Target 1 (activating neural circuits to inhibit gaming behavior \[breaking old habits\]) and Target 2 (promoting social rewards to replace gaming behavior \[establishing new habits\])-this dual-target design forms a complete learning loop of "inhibiting impulses → obtaining healthy rewards," simulating the behavioral patterns of a healthy brain. A three-group between-subjects design was employed to isolate the unique effects of the "social reward" component; each session consisted of 30 minutes of neurofeedback training, four times a week, for four consecutive weeks. Dual-regulation group: Received comprehensive "neural circuit activation + promotion of social reward" dual neurofeedback training.

Dual-regulation group

1. Conduct a single-blind, randomized controlled trial. The 40 participants assigned to the single-modulation group will receive only "inhibitory" neurofeedback training targeting the dACC-DLPFC circuit (activating the neural circuit only, without promoting social reward). 2. Assessments will include standardized scales, behavioral tests, and neuroimaging, each administered once before and after the intervention. 3. During neurofeedback training, participants will undergo training four times per week, for a total of 16 sessions. 4. The entire intervention will last approximately one month. To track the immediacy and sustainability of the intervention's effects, the above measures will be collected at all four time points: baseline (T0), immediately post-intervention (T1), and at 6-month (T2) and 12-month (T3) follow-ups.

Single-regulation group( Neural Circuits Activation Only )
Sham FeedbackBEHAVIORAL

1\. Conduct a single-blind, randomized controlled trial. The 40 participants assigned to the sham feedback group will follow the same task protocol but receive sham feedback unrelated to their own brain activity. 2. Assessments, including standardized scales, behavioral tests, and neuroimaging, will be conducted once before and once after the intervention.3. During neurofeedback training, participants will undergo training four times per week, for a total of 16 sessions. 4. The entire intervention will last approximately one month. To track the immediacy and sustainability of the intervention's effects, the above measures will be collected at all four time points: baseline (T0), immediately post-intervention (T1), and at 6-month (T2) and 12-month (T3) follow-ups.

Sham Feedback group (none contingent feedback)

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Individuals aged between 18 and 35 years, irrespective of gender, having completed a minimum of 9 years of education and capable of effectively cooperating in questionnaire evaluations
  • Consent to actively cooperate in the completion of subsequent follow-up assessments
  • Right-handed
  • The Gaming Disorder Screening (GDSS) Scale score ≥ 47 points
  • Average weekly gaming time greater than 21 hours, maintained for over one year
  • More than 50% of daily internet time spent playing online games

You may not qualify if:

  • Severe cognitive functional impairments manifested through a history of head trauma, cerebrovascular diseases, epilepsy, etc., or usage of cognitive enhancement drugs in the past 6 months
  • Left-handed
  • An intellectual disability with an IQ score less than 70
  • A diagnosis of schizophrenia or other severe mental illnesses as per the DSM-5 criteria
  • Abuse or dependence on other psychoactive substances (excluding nicotine) within the past 5 years
  • Severe organic diseases that might compromise study participation
  • Color blindness or color weakness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bengbu Medical University

Bengbu, China

RECRUITING

MeSH Terms

Conditions

Internet Addiction Disorder

Condition Hierarchy (Ancestors)

Technology AddictionBehavior, AddictiveCompulsive BehaviorImpulsive BehaviorBehavior

Study Officials

  • Dongliang Jiao, doctor

    School of Mental Health, Bengbu Medical University

    STUDY CHAIR

Central Study Contacts

Dongliang Jiao, doctor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2026

First Posted

September 28, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

December 30, 2028

Study Completion (Estimated)

December 30, 2028

Last Updated

September 28, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations