AVE-Neurofeedback for Academic Anxiety and Divergent Thinking

NCT07745335 | Not Yet Recruiting DMC

• 1 other identifier: AVE-NFB-RCT-DRS-NFO-2026-001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

Academic Anxiety; Test Anxiety; Adolescent Mental Health; Stress, Psychological; Cognitive Performance; Divergent Thinking

Keywords

Closed-Loop Brain-Computer Interface; Neural Oscillation; Alpha-Band Neurofeedback; Neuroplasticity; Cognitive Enhancement; Adolescent Neuroscience; School-Based Intervention

Outcome Measures

Primary Outcomes (1)

• Resting-State Alpha Power

  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.

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

Secondary Outcomes (6)

• 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)

Study Arms (4)

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 Muse S Athena wearable EEG system.

Device: Audiovisual Entrainment Neurofeedback (AVE-NFB)

Neurofeedback Only

EXPERIMENTAL

Participants will receive adaptive EEG-HRV neurofeedback using the Muse S Athena wearable EEG system. 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.

Device: Neurofeedback Only

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.

Behavioral: Audiovisual Entrainment

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 Muse S Athena headset 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.

Behavioral: Sham Control

Interventions

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.

Audiovisual Entrainment Neurofeedback (AVE-NFB)

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.

Neurofeedback Only

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.

Audiovisual Entrainment Only

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.

Sham Control

Eligibility Criteria

• Age: 15 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Daniswara Raditya Suprapto: lead

Study Sites (2)

SMA Taruna Nusantara

Magelang, Central Java, 56172, Indonesia

Location

SMA Negeri 1 Nganjuk

Nganjuk, East Java, 64415, Indonesia

Location

Related Publications (8)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 DMA, Luhrs M, Lubar J, Lotte F, Linden DEJ, Lewis-Peacock JA, Lebedev MA, Lanius RA, Kubler A, Kranczioch C, Koush Y, Konicar L, Kohl SH, Kober SE, Klados MA, Jeunet C, Janssen TWP, Huster RJ, Hoedlmoser K, Hirshberg LM, Heunis S, Hendler T, Hampson M, Guggisberg AG, Guggenberger R, Gruzelier JH, Gobel RW, Gninenko N, Gharabaghi A, Frewen P, Fovet T, Fernandez T, Escolano C, Ehlis AC, Drechsler R, Christopher deCharms R, Debener S, De Ridder D, Davelaar EJ, Congedo M, Cavazza M, Breteler MHM, Brandeis D, Bodurka J, Birbaumer N, Bazanova OM, Barth B, Bamidis PD, Auer T, Arns M, Thibault RT. Consensus on the reporting and experimental design of clinical and cognitive-behavioural neurofeedback studies (CRED-nf checklist). Brain. 2020 Jun 1;143(6):1674-1685. doi: 10.1093/brain/awaa009.

  PMID: 32176800 BACKGROUND

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Saraswati Eva Yuswikarini, M.Psi., Psychologist

  HIMPSI

  STUDY DIRECTOR

Central Study Contacts

Daniswara Raditya Suprapto

CONTACT

+6289502459696; daniswara.raditya144@sma.belajar.id

Navysa Fatah Onawa

CONTACT

+6281252278367; 2411464@magelang.tarunanusantara.sch.id

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lead Student Researcher under Supervisor Oversight

Model Details: Participants will be randomly assigned in a 1:1:1:1 ratio to one of four parallel intervention groups: (1) Combined Audiovisual Entrainment Neurofeedback (AVE-NFB), (2) Neurofeedback Only, (3) Audiovisual Entrainment Only, or (4) Sham Control. Each participant will remain in the assigned intervention arm throughout the six-week intervention period without crossover. Outcome assessments will be performed at baseline, immediately post-intervention, one-week follow-up, and one-month follow-up.

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 4, 2026
• Study Start (Estimated): August 25, 2026
• Primary Completion (Estimated): November 25, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: August 4, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

ID (2)