跳至主要内容
临床试验/NCT07745335
NCT07745335招募中不适用

Efficacy of a Multisensory Audiovisual Entrainment Neurofeedback for Academic Anxiety Regulation and Divergent Thinking: A Randomized Controlled Trial Study

Daniswara Raditya Suprapto5 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2026年9月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
240
试验地点
5
主要终点
Resting-State Alpha Power

研究概览

简要总结

Academic anxiety is one of the most prevalent psychological challenges among adolescents and has been associated with impaired executive functioning, attentional control, autonomic dysregulation, and reduced creative performance. Although neurofeedback and audiovisual entrainment have independently demonstrated beneficial effects on neural self-regulation, evidence regarding their integration within an adaptive closed-loop intervention remains limited.

This multicenter, parallel-group, randomized controlled trial aims to evaluate the efficacy of an Audiovisual Entrainment Neurofeedback (AVE-NFB) system for improving neural self-regulation, reducing academic anxiety, enhancing autonomic regulation, and promoting divergent thinking among senior high school students. A total of 240 participants recruited from two school centers will be randomly allocated to one of four intervention groups: Combined AVE-Neurofeedback, Neurofeedback Only, Audiovisual Entrainment Only, or Sham Control.

Each participant will complete 12 intervention sessions over a six-week intervention period (administered twice weekly). During every session, brain activity will be continuously acquired using the Emotiv Epoc X 14-channel research-grade electroencephalography (EEG) headset (256 Hz sampling rate). Following a standardized 5-minute resting calibration (3 minutes eyes closed and 2 minutes eyes open), the system will estimate each participant's individualized resting alpha activity (8-12 Hz). The neurofeedback engine continuously monitors alpha-band power from the multi-channel frontal (AF3, F7, F3, FC5, FC6, F4, F8, AF4) and temporoparietal (T7, P7, T8, P8) electrodes. Positive audiovisual reinforcement is automatically activated whenever the participant maintains alpha power above the individualized reinforcement threshold for at least 2 seconds while satisfying artifact-quality criteria. Reinforcement is automatically attenuated or suspended whenever alpha activity falls below the threshold or excessive ocular or motion artifacts are detected, thereby establishing a fully adaptive closed-loop reinforcement process based on operant conditioning principles.

Outcome assessments will be performed at baseline, immediately after completion of the intervention, one week after the intervention, and one month after the intervention. Primary neural outcomes will include resting-state absolute alpha power measured using the Emotiv Epoc X 14-channel EEG. Secondary outcomes will include academic anxiety assessed using the Spielberger Test Anxiety Inventory (TAI), autonomic regulation assessed using Heart Rate Variability using the Root Mean Square of Successive Differences (RMSSD), and divergent thinking assessed using the Alternative Uses Task (AUT).

详细描述

Background Academic anxiety is a major psychological concern among adolescents and has consistently been associated with impaired executive functioning, attentional control, emotional regulation, autonomic imbalance, and reduced creative cognition. Neurophysiological evidence indicates that these impairments are accompanied by dysregulated cortical alpha oscillations and reduced parasympathetic nervous system activity. Neurofeedback enables individuals to voluntarily regulate neural oscillatory activity through real-time electroencephalographic feedback, whereas audiovisual entrainment facilitates neural synchronization using rhythmic photic stimulation and binaural auditory stimulation. Despite encouraging evidence supporting each intervention independently, limited research has investigated their integration within an adaptive closed-loop neurofeedback architecture capable of delivering individualized reinforcement based on ongoing neural activity.

Objectives The primary objective of this study is to determine whether an Audiovisual Entrainment Neurofeedback (AVE-NFB) system produces greater increases in resting-state absolute alpha-band power than isolated neurofeedback, isolated audiovisual entrainment, or sham intervention.Secondary objectives are to evaluate changes in academic anxiety, autonomic nervous system regulation, divergent thinking, and the durability of treatment effects during one-week and one-month follow-up assessments.

Study Design This study is a multicenter, four-arm, parallel-group, randomized controlled trial involving 240 participants recruited from two senior high school centers. Participants will be randomly assigned to one of four intervention groups: (1) Combined AVE-Neurofeedback; (2) Neurofeedback Only; (3); Audiovisual Entrainment Only & (4) Sham Control. Each participant will complete 12 intervention sessions across a six-week period (administered twice weekly). Outcome assessments will be conducted at: (1) Baseline (Week 0); (2) Immediately Post-intervention (Week 6); (3) One-week Follow-up (Week 7); (4) One-month Follow-up (Week 10)

Closed-Loop Neurofeedback Mechanism The Audiovisual Entrainment Neurofeedback (AVE-NFB) employs a fully adaptive closed-loop brain-computer interface integrating real-time EEG monitoring with synchronized audiovisual entrainment.EEG signals are continuously acquired using the Emotiv Epoc X 14-channel research-grade EEG headset at a sampling frequency of 256 Hz from saline-based electrodes positioned at AF3, F7, F3, FC5, T7, P7, O1, O2, P8, T8, FC6, F4, F8, and AF4, mapped according to the International 10-20 system. Each intervention session begins with a standardized 5-minute calibration period consisting of 3 minutes of eyes-closed resting state followed by 2 minutes of eyes-open resting state. Calibration data are used to establish each participant's individualized resting absolute alpha-band activity (8-12 Hz).During neurofeedback training, EEG signals undergo automated quality control, including artifact detection for eye blinks, excessive movement, and poor electrode contact across all 14 channels. Only artifact-free epochs are processed for online estimation of absolute alpha-band power using short overlapping analysis windows averaged across the frontal and temporoparietal regions of interest.The individualized reinforcement threshold is initialized at 110% of the participant's median resting absolute alpha power obtained during calibration. Throughout each training session, this threshold is dynamically adjusted by a physiological controller driven by rolling Heart Rate Variability (RMSSD) estimates. Positive reinforcement is delivered only when alpha power remains continuously above this adaptive threshold for at least 2 consecutive seconds while signal quality satisfies predefined artifact acceptance criteria.

Successful threshold attainment automatically activates synchronized audiovisual reinforcement consisting of: (1) Alpha-frequency rhythmic photic stimulation; (2) Binaural beat auditory stimulation centered within the alpha range; (3) Non-directive relaxation guidance & (4) Continuous visual performance feedback. Whenever alpha activity decreases below the reinforcement threshold or excessive artifacts are detected, audiovisual reinforcement is immediately attenuated or suspended until stable neural activity resumes. This adaptive reinforcement paradigm is designed to strengthen voluntary alpha self-regulation through operant conditioning rather than passive sensory stimulation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Participants allocated to the intervention arms will remain unaware of the specific treatment allocation whenever feasible. Outcome assessors responsible for EEG preprocessing, heart rate variability analysis, psychological scoring, and statistical analyses will remain blinded to treatment assignment until completion of primary analyses. Intervention providers administering the neurofeedback protocol cannot be blinded because of the operational characteristics of the intervention.

入排标准

年龄范围
15 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Senior high school students aged 15-18 years.
  • Elevated academic anxiety according to screening assessment.
  • Able to understand study procedures.
  • Willing to provide written informed consent (and parental consent where required).

排除标准

  • History of epilepsy or seizure disorders.
  • Neurological disorders.
  • Severe psychiatric disorders.
  • Current psychoactive medication affecting EEG activity.
  • Significant visual impairment incompatible with photic stimulation.
  • Previous neurofeedback training within the last six months.

研究组 & 干预措施

Audiovisual Entrainment Neurofeedback (AVE-NFB)

Experimental

Participants will receive adaptive multimodal Audiovisual Entrainment Neurofeedback (AVE-NFB) integrating real-time EEG neurofeedback, heart rate variability (HRV)-guided adaptive thresholding, alpha-frequency photic stimulation, binaural beat auditory stimulation, non-directive relaxation guidance, and visual neurofeedback using the Emotiv Epoc X.

干预措施: Audiovisual Entrainment Neurofeedback (AVE-NFB) (Device)

Neurofeedback Only

Experimental

Participants will receive adaptive EEG-HRV neurofeedback using the Emotiv Epoc X EEG. Individualized alpha-band activity will provide real-time visual neurofeedback, while rolling HRV (RMSSD) estimates will dynamically adjust individualized reinforcement thresholds. No photic stimulation, binaural beat stimulation, or non-directive relaxation guidance will be delivered.

干预措施: Neurofeedback Only (Device)

Audiovisual Entrainment Only

Experimental

Participants will receive standardized alpha-frequency audiovisual entrainment consisting of rhythmic photic stimulation, binaural beat auditory stimulation, and non-directive relaxation guidance. The intervention will be delivered without EEG neurofeedback, HRV-guided adaptation, or individualized physiological feedback.

干预措施: Audiovisual Entrainment (Behavioral)

Sham Control

Sham Comparator

Participants will undergo a sham intervention using identical equipment, procedures, session duration, and environmental conditions as the active intervention groups. Although the EEG and HRV sensor will be attached, neither EEG nor HRV signals will influence the feedback provided. Any visual or audiovisual feedback will be pre-programmed and non-contingent on participants' physiological activity.

干预措施: Sham Control (Behavioral)

结局指标

主要结局

Resting-State Alpha Power

时间窗: Baseline, immediately post-intervention (Week 6), 1-week follow-up (Week 7), and 1-month follow-up (Week 10)

Measured via quantitative electroencephalography (qEEG) spectral analysis using the Emotiv Epoc X 14-channel research-grade EEG system from multi-channel frontal (AF3, F7, F3, FC5, FC6, F4, F8, AF4) and temporoparietal (T7, P7, T8, P8) regions of interest. Absolute alpha power is calculated within the 8-12 Hz frequency band during a 5-minute resting state (standardized 3-minute eyes-closed and 2-minute eyes-open calibration phase). The power is quantified in microvolts squared (µV²). An increase in absolute alpha-band power represents enhanced neural self-regulation and a state of relaxed alertness.

次要结局

  • Academic Test Anxiety(Baseline, immediately post-intervention (Week 6), 1-week follow-up (Week 7), and 1-month follow-up (Week 10))
  • Heart Rate Variability (RMSSD)(Baseline, immediately post-intervention (Week 6), 1-week follow-up (Week 7), and 1-month follow-up (Week 10))
  • Divergent Thinking - Fluency Score(Baseline, immediately post-intervention (Week 6), 1-week follow-up (Week 7), and 1-month follow-up (Week 10))
  • Divergent Thinking - Flexibility Score(Baseline, immediately post-intervention (Week 6), 1-week follow-up (Week 7), and 1-month follow-up (Week 10))
  • Divergent Thinking - Originality Score(Baseline, immediately post-intervention (Week 6), 1-week follow-up (Week 7), and 1-month follow-up (Week 10))
  • Divergent Thinking - Elaboration Score(Baseline, immediately post-intervention (Week 6), 1-week follow-up (Week 7), and 1-month follow-up (Week 10))

研究者

发起方
Daniswara Raditya Suprapto
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Daniswara Raditya Suprapto

Lead Student Researcher under Supervisor Oversight

SMA NEGERI 1 NGANJUK

研究点 (5)

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