Academic AnxietyAVE-NFBNCT07745335
AVE-Neurofeedback for Academic Anxiety and Divergent Thinking
A study testing Audiovisual Entrainment Neurofeedback (AVE-NFB), Neurofeedback Only and Audiovisual Entrainment in people with Academic Anxiety and Test Anxiety, run by Daniswara Raditya Suprapto at 3 sites in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Academic Anxiety, Test Anxiety, Divergent Thinking
- What is being tested?
- Audiovisual Entrainment Neurofeedback (AVE-NFB), Neurofeedback Only and Audiovisual Entrainment
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 3 sitesIndonesia
- Study dates
- 4 Sep 2026to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia3 sites, 3 recruiting
- Not yet recruiting
SMA Taruna Nusantara
Magelang, Central Java, 56172
Susilo Tri Atmojo, S.Si, +62 858-7932-7398, susilotn.35@gmail.com
- Recruiting
Rumah Sakit Daerah (RSD) Nganjuk
Nganjuk, East Java, 64415
Ridha Yustiana, +62 858-5575-4690, infoyan@rsd.nganjukkab.go.id
- Not yet recruiting
SMA Negeri 1 Nganjuk
Nganjuk, East Java, 64415
Finiswatin S.Pd., M.Pd, Master, +6281235088880, smasa_nganjuk@yahoo.co.id
About this study
Official title: Efficacy of a Multisensory Audiovisual Entrainment Neurofeedback for Academic Anxiety Regulation and Divergent Thinking: A Randomized Controlled Trial Study
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.
Read more
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).
Read the detailed description
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.
Throughout each session, the system automatically records continuous 14-channel 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 via spectral analysis using the Emotiv Epoc X 14-channel 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.
Power Analysis An a priori power analysis indicates that a total sample size of N = 240 (n = 60 per arm) provides over 80% statistical power to detect a small-to-medium interaction effect size (f = 0.20) in a longitudinal repeated-measures design with four groups and four timepoints, assuming a conservative 15% attrition rate and an alpha level of 0.05.
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.
- Conditions
- Academic Anxiety, Test Anxiety, Divergent Thinking
- Being tested
- Audiovisual Entrainment Neurofeedback (AVE-NFB), Neurofeedback Only, Audiovisual Entrainment, Sham Control
- Keywords
- Closed-Loop Brain-Computer Interface, Neural Oscillation, Alpha-Band Neurofeedback, Neuroplasticity, Cognitive Enhancement, Adolescent Neuroscience, School-Based Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audiovisual Entrainment Neurofeedback (AVE-NFB)Device
Participants will receive 12 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 Emotiv Epoc X EEG, 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 OnlyDevice
Participants will receive adaptive EEG-HRV neurofeedback without audiovisual entrainment. Continuous EEG activity 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. 12 intervention sessions will be completed over approximately six weeks.
Audiovisual EntrainmentBehavioural
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 12 intervention sessions over approximately 6 weeks.
Sham ControlBehavioural
Participants will undergo a sham intervention designed to replicate the appearance and procedures of the active interventions. The Emotiv Epoc X EEG and Polar H10 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 (12 sessions).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Audiovisual Entrainment Neurofeedback (AVE-NFB) |
| 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. Receives: 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. Receives: 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 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. Receives: Behavioral: Sham Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting-State Alpha Power
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.
Measured: 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
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.
Measured: Baseline, immediately post-intervention (Week 6), 1-week follow-up (Week 7), and 1-month follow-up (Week 10)
Heart Rate Variability (RMSSD)
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.
Measured: Baseline, immediately post-intervention (Week 6), 1-week follow-up (Week 7), and 1-month follow-up (Week 10)
Divergent Thinking - Fluency Score
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.
Measured: Baseline, immediately post-intervention (Week 6), 1-week follow-up (Week 7), and 1-month follow-up (Week 10)
Divergent Thinking - Flexibility Score
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.
Measured: Baseline, immediately post-intervention (Week 6), 1-week follow-up (Week 7), and 1-month follow-up (Week 10)
Divergent Thinking - Originality Score
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.
Measured: Baseline, immediately post-intervention (Week 6), 1-week follow-up (Week 7), and 1-month follow-up (Week 10)
Divergent Thinking - Elaboration Score
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.
Measured: Baseline, immediately post-intervention (Week 6), 1-week follow-up (Week 7), and 1-month follow-up (Week 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start4 Sep 2026 (estimated)
- Primary completion25 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Academic AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daniswara Raditya Suprapto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Daniswara Raditya Suprapto, SMA NEGERI 1 NGANJUK
- Investigators
- Saraswati Eva Yuswikarini, M.Psi., Psychologist, Study director, HIMPSI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07745335
- Sponsor's protocol ID
- AVE-NFB-RCT-DRS-NFO-2026-001
- Acronym
- AVE-NFB
- Status last verified
- Sep 2026
- First submitted
- 29 Jul 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the informed consent obtained from participants does not include permission for public sharing of de-identified individual-level data. Aggregate study results will be reported through scientific publications.
Publications
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.
PubMed 37239069Gubenko 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.
PubMed 36118496Attar 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.
PubMed 34513342Caci 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.
PubMed 14680715Henao 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.
PubMed 32201357Shaffer 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.
PubMed 29034226Gruzelier 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.
PubMed 24690579Ros 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.
PubMed 32176800
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Multisensory Audiovisual Entrainment Neurofeedback for Academic Anxiety Regulation and Divergent Thinking: A Randomized Controlled Trial Study
- ClinicalTrials.gov ID
- NCT07745335
- Acronym / sponsor ID
- AVE-NFB / AVE-NFB-RCT-DRS-NFO-2026-001
- Conditions
- Academic Anxiety, Test Anxiety, Divergent Thinking
- Keywords
- Closed-Loop Brain-Computer Interface, Neural Oscillation, Alpha-Band Neurofeedback, Neuroplasticity, Cognitive Enhancement, Adolescent Neuroscience, School-Based Intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Daniswara Raditya SupraptoUniversity, hospital or other
- Study start
- 4 Sep 2026 (estimated)
- Primary completion
- 25 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 4 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Throughout each session, the system automatically records continuous 14-channel 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 via spectral analysis using the Emotiv Epoc X 14-channel 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.
Power Analysis An a priori power analysis indicates that a total sample size of N = 240 (n = 60 per arm) provides over 80% statistical power to detect a small-to-medium interaction effect size (f = 0.20) in a longitudinal repeated-measures design with four groups and four timepoints, assuming a conservative 15% attrition rate and an alpha level of 0.05.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Audiovisual Entrainment Neurofeedback (AVE-NFB) | Experimental | Device: Audiovisual Entrainment Neurofeedback (AVE-NFB)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. |
| Neurofeedback Only | Experimental | Device: Neurofeedback OnlyParticipants 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. |
| Audiovisual Entrainment Only | Experimental | Behavioral: Audiovisual EntrainmentParticipants 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. |
| Sham Control | Sham comparator | Behavioral: Sham ControlParticipants 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. |
Who may qualify
- Ages
- 15 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (6 listed)
- History of epilepsy or seizure disorders.
- Neurological disorders.
- Severe psychiatric disorders.
- Current psychoactive medication affecting EEG activity.
- Significant visual impairment incompatible with photic stimulation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Audiovisual Entrainment Neurofeedback (AVE-NFB)Participants will receive 12 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 Emotiv Epoc X EEG, 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. | Device | Audiovisual Entrainment Neurofeedback (AVE-NFB) |
| Neurofeedback OnlyParticipants will receive adaptive EEG-HRV neurofeedback without audiovisual entrainment. Continuous EEG activity 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. 12 intervention sessions will be completed over approximately six weeks. | Device | Neurofeedback Only |
| Audiovisual EntrainmentParticipants 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 12 intervention sessions over approximately 6 weeks. | Behavioural | Audiovisual Entrainment Only |
| Sham ControlParticipants will undergo a sham intervention designed to replicate the appearance and procedures of the active interventions. The Emotiv Epoc X EEG and Polar H10 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 (12 sessions). | Behavioural | Sham Control |
Primary outcome
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 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.
6 secondary outcomes
Academic Test Anxiety
Time frame: Baseline, immediately post-intervention (Week 6), 1-week follow-up (Week 7), and 1-month follow-up (Week 10)
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)
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)
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)
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Background: PubMed 37239069Gallina 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.
- Background: PubMed 36118496Gubenko 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.
- Background: PubMed 34513342Attar 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.
- Background: PubMed 14680715Caci 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.
- Background: PubMed 32201357Henao 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.
- Background: PubMed 29034226Shaffer 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.
- Background: PubMed 24690579Gruzelier 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.
- Background: PubMed 32176800Ros 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the informed consent obtained from participants does not include permission for public sharing of de-identified individual-level data. Aggregate study results will be reported through scientific publications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Saraswati Eva Yuswikarini, M.Psi., Psychologist study director
HIMPSI
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Audiovisual Entrainment Neurofeedback (AVE-NFB), Neurofeedback Only and Audiovisual Entrainment in people with Academic Anxiety and Test Anxiety, run by Daniswara Raditya Suprapto at 3 sites in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniswara Raditya Suprapto (+6289502459696, daniswara.raditya144@sma.belajar.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07745335, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.