About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
"Activate Neural Circuits + Promote Social Rewards" Dual-target Neurofeedback Training
BehavioralUsing 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.
"Activate Only the Neural Circuits" Neurofeedback Training
Behavioral1. 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.
Sham Feedback
Behavioral1\. 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.
Treatment groups
Trial outcomes
Primary outcomes
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
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
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.
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.
Secondary outcomes
Changes of Electrophysiological Indicators
Event-related potential (ERP) components N200 elicited during the Stop-Signal Task were analyzed with respect to amplitude . N200 amplitude indexed conflict monitoring.
Changes of Electrophysiological Indicators
Event-related potential (ERP) components P300 elicited during the Stop-Signal Task were analyzed with respect to latency. P300 latency reflected inhibitory control capacity.
Neuroimaging Indicators
Functional magnetic resonance imaging (fMRI) was used to assess the strength of functional connectivity between the dorsal anterior cingulate cortex (dACC) and the dorsolateral prefrontal cortex (DLPFC)
Sponsors and contacts
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The First Affiliated Hospital of Bengbu Medical University
Lead sponsor
Bengbu Medical University
Collaborator