AVE-Neurofeedback for Academic Anxiety and Divergent Thinking

Официальное название

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

Обзор

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 120 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 six intervention sessions over a six-week intervention period. During every session, brain activity will be continuously acquired using the Muse S Athena wearable 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 bilateral frontal (AF7 and AF8) and temporoparietal (TP9 and TP10) 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 Muse S Athena 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).

Подробное описание

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 120 participants recruited from two senior high school centers. Participants will be randomly assigned to one of four intervention groups:

Combined AVE-Neurofeedback Neurofeedback Only Audiovisual Entrainment Only Sham Control

Each participant will complete six intervention sessions across approximately six weeks.

Outcome assessments will be conducted at:

Baseline (Week 0) Immediately Post-intervention (Week 6) One-week Follow-up (Week 7) 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 Muse S Athena wearable EEG headset at a sampling frequency of 256 Hz from four dry electrodes positioned at AF7, AF8, TP9, and TP10. 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. Only artifact-free epochs are processed for online estimation of absolute alpha-band power using short overlapping analysis windows.

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:

Alpha-frequency rhythmic photic stimulation, Binaural beat auditory stimulation centered within the alpha range, Non-directive relaxation guidance, 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.

Throughout each session, the system automatically records continuous EEG signals, artifact events, individualized threshold values, reinforcement activation duration, cumulative reinforcement time, session performance indices, and event timestamps for subsequent offline verification and statistical analysis.

Outcome Measures Primary Outcome

Resting-State Absolute Alpha Power (8-12 Hz) measured using the Muse S Athena wearable EEG headset.

Secondary Outcomes Academic anxiety assessed using the Spielberger Test Anxiety Inventory (TAI). Autonomic nervous system regulation assessed using Heart Rate Variability (RMSSD).

Divergent thinking assessed using the Alternative Uses Task (AUT), including fluency, flexibility, originality, and elaboration scores.

Statistical Analysis

Longitudinal repeated-measures data will be analyzed using Linear Mixed-Effects Models (LMM). Treatment group, assessment time, and the group-by-time interaction will be specified as fixed effects, whereas participant-specific random intercepts will account for within-subject dependency. School center, circadian assessment phase, and intervention session timing will be incorporated as predefined covariates. The LMM framework was selected because it appropriately accommodates repeated measurements, multicenter clustering, and incomplete follow-up observations under the missing-at-random assumption while preserving statistical efficiency.

Expected Significance

This study is expected to provide rigorous evidence regarding the efficacy of adaptive closed-loop multisensory neurofeedback for improving cortical alpha self-regulation, reducing academic anxiety, enhancing autonomic nervous system function, and promoting divergent thinking among adolescents. The findings may contribute to the development of scalable, neuroscience-based, non-pharmacological interventions for school mental health and cognitive enhancement.

Вмешательства

• Устройство Audiovisual Entrainment Neurofeedback (AVE-NFB)
  Participants will receive 6 Session of an Audiovisual Entrainment Neurofeedback (AVE-NFB) intervention integrating real-time electroencephalography (EEG) and heart rate variability (HRV) biofeedback. Neural activity will be continuously acquired using the Muse S Athena wearable EEG headset, while cardiac activity will be simultaneously recorded using Polar H10 for heart rate variability analysis. Individualized alpha-band activity (8-12 Hz) will serve as the primary real-time neurofeedback signa
• Устройство Neurofeedback Only
  Participants will receive adaptive EEG-HRV neurofeedback without audiovisual entrainment. Continuous EEG activity acquired using the Muse S Athena headset will provide the primary neurofeedback signal based on individualized alpha-band activity (8-12 Hz), while rolling RMSSD estimates will continuously optimize reinforcement thresholds throughout each session. Participants will receive real-time visual feedback contingent upon their ongoing neural activity. No rhythmic photic stimulation, binaur
• Поведенческое Audiovisual Entrainment
  Participants will receive standardized alpha-frequency audiovisual entrainment consisting of rhythmic photic stimulation, binaural beat auditory stimulation, and standardized non-directive relaxation guidance. Stimulation parameters will remain fixed throughout each session without EEG acquisition, HRV biofeedback, individualized threshold adaptation, or brain-state-dependent reinforcement. Participants will complete six intervention sessions over approximately six weeks.
• Поведенческое Sham Control
  Participants will undergo a sham intervention designed to replicate the appearance and procedures of the active interventions. The Muse S Athena headset and HRV sensor will be attached using identical preparation procedures; however, neither EEG activity nor HRV measurements will influence the audiovisual presentation or visual feedback. Any displayed feedback will be pre-programmed and non-contingent on participants' physiological activity. Session duration, operator interaction, and environmen

Первичные конечные точки

• Resting-State Alpha Power [Срок оценки: Baseline, immediately post-intervention (Week 6), 1-week follow-up (Week 7), and 1-month follow-up (Week 10)]

Вторичные конечные точки (6)

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

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Индонезия · 2 центра

• SMA Taruna Nusantara — Magelang
• SMA Negeri 1 Nganjuk — Nganjuk

Публикации

• Gallina J, Marsicano G, Romei V, Bertini C. Electrophysiological and Behavioral Effects of Alpha-Band Sensory Entrainment: Neural Mechanisms and Clinical Applications. Biomedicines. 2023 May 8;11(5):1399. doi: 10.3390/biomedicines11051399. PMID 37239069
• Gubenko A, Houssemand C. Alternative Object Use in Adults and Children: Embodied Cognitive Bases of Creativity. Front Psychol. 2022 Sep 2;13:893420. doi: 10.3389/fpsyg.2022.893420. eCollection 2022. PMID 36118496
• Attar ET, Balasubramanian V, Subasi E, Kaya M. Stress Analysis Based on Simultaneous Heart Rate Variability and EEG Monitoring. IEEE J Transl Eng Health Med. 2021 Aug 23;9:2700607. doi: 10.1109/JTEHM.2021.3106803. eCollection 2021. PMID 34513342
• Caci H, Bayle FJ, Dossios C, Robert P, Boyer P. The Spielberger Trait Anxiety Inventory measures more than anxiety. Eur Psychiatry. 2003 Dec;18(8):394-400. doi: 10.1016/j.eurpsy.2003.05.003. PMID 14680715
• Henao D, Navarrete M, Valderrama M, Le Van Quyen M. Entrainment and synchronization of brain oscillations to auditory stimulations. Neurosci Res. 2020 Jul;156:271-278. doi: 10.1016/j.neures.2020.03.004. Epub 2020 Mar 19. PMID 32201357
• Shaffer F, Ginsberg JP. An Overview of Heart Rate Variability Metrics and Norms. Front Public Health. 2017 Sep 28;5:258. doi: 10.3389/fpubh.2017.00258. eCollection 2017. PMID 29034226
• Gruzelier JH. EEG-neurofeedback for optimising performance. III: a review of methodological and theoretical considerations. Neurosci Biobehav Rev. 2014 Jul;44:159-82. doi: 10.1016/j.neubiorev.2014.03.015. Epub 2014 Mar 29. PMID 24690579
• Ros T, Enriquez-Geppert S, Zotev V, Young KD, Wood G, Whitfield-Gabrieli S, Wan F, Vuilleumier P, Vialatte F, Van De Ville D, Todder D, Surmeli T, Sulzer JS, Strehl U, Sterman MB, Steiner NJ, Sorger B, Soekadar SR, Sitaram R, Sherlin LH, Schonenberg M, Scharnowski F, Schabus M, Rubia K, Rosa A, Reiner M, Pineda JA, Paret C, Ossadtchi A, Nicholson AA, Nan W, Minguez J, Micoulaud-Franchi JA, Mehler PMID 32176800

Идентификаторы

NCT: NCT07745335 · AVE-NFB-RCT-DRS-NFO-2026-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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