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NCT Number: NCT07745335

AVE-Neurofeedback for Academic Anxiety and Divergent Thinking

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).

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Key information

Age range

15 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SMA Taruna Nusantara, Magelang, Central Java, Indonesia

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

Audiovisual Entrainment Neurofeedback (AVE-NFB)

Device

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 signal, whereas rolling Root Mean Square of Successive Differences (RMSSD) estimates will function as an adaptive physiological controller to dynamically adjust individualized reinforcement thresholds throughout training. Whenever alpha activity exceeds the adaptive threshold under acceptable signal-quality conditions, synchronized alpha-frequency photic stimulation, binaural beat auditory stimulation, non-directive relaxation guidance, and visual neurofeedback will be automatically delivered.

Neurofeedback Only

Device

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, binaural beat stimulation, or non-directive relaxation guidance will be administered. Six intervention sessions will be completed over approximately six weeks.

Audiovisual Entrainment

Behavioral

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.

Sham Control

Behavioral

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 environmental conditions will be identical to those of the active intervention groups.

Primary outcomes

  1. Resting-State Alpha Power

    Time frame: 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 Muse S Athena wearable EEG system from bilateral frontal (AF7, AF8) and temporoparietal (TP9, TP10) channels. Absolute alpha power is calculated within the 8-12 Hz frequency band during a 5-minute resting state (eyes-closed and eyes-open calibration). 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.

Secondary outcomes

  1. Academic Test Anxiety

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

    Assessed using the Spielberger Test Anxiety Inventory (TAI). The total score ranges from a minimum of 20 to a maximum of 80. A higher total score indicates a greater and more severe level of academic and test anxiety.

  2. Heart Rate Variability (RMSSD)

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

    Quantified using the root mean square of successive differences (RMSSD) derived from cardiac activity monitored via the Polar H10 device. Measured in milliseconds (ms). Higher RMSSD values indicate enhanced parasympathetic nervous system activity and improved autonomic regulation.

  3. Divergent Thinking - Fluency Score

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

    Evaluated using the Alternative Uses Task (AUT). The fluency score represents the total number of unique alternative uses generated by the participant for the target objects. The score ranges from a minimum of 0 to no theoretical upper limit. Higher scores indicate a greater quantity of generated ideas.

  4. Divergent Thinking - Flexibility Score

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

    Evaluated using the Alternative Uses Task (AUT). The flexibility score reflects the number of distinct conceptual categories or domains into which the participant's responses fall. The score ranges from a minimum of 0 to no theoretical upper limit. Higher scores indicate a greater conceptual diversity of thought.

  5. Divergent Thinking - Originality Score

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

    Evaluated using the Alternative Uses Task (AUT). The originality score measures the statistical novelty or uniqueness of the participant's ideas compared to the total sample pool or established baseline rubric. The score ranges from a minimum of 0 to no theoretical upper limit. Higher scores indicate a higher degree of unique and creative cognition.

  6. Divergent Thinking - Elaboration Score

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

    Evaluated using the Alternative Uses Task (AUT). The elaboration score indicates the level of detail, development, and descriptiveness embedded within each proposed alternative use. The score ranges from a minimum of 0 to no theoretical upper limit. Higher scores indicate more thoroughly developed ideas.

Study contacts

Contact information is provided by the study sponsor or research team.

Daniswara Raditya Suprapto

CONTACT

[email protected]

+6289502459696

Navysa Fatah Onawa

CONTACT

[email protected]

+6281252278367

Sponsors and collaborators

Lead sponsor

Daniswara Raditya Suprapto

Other

Registry information

Official study title

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

Acronym: AVE-NFB

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Aug 4, 2026
Registry last updated
Aug 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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