[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650162":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":47,"centralContacts":52,"locations":62,"responsibleParty":96,"collaborators":35,"id":99,"slug":100,"hasResults":101,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":107,"sex":108,"minAge":109,"maxAge":110,"enrollmentInfo":111,"targetDuration":35,"studyType":114,"phases":115,"briefSummary":117,"conditions":118,"keywords":122,"overallStatus":130,"whyStopped":35,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":140},{"fullName":5,"class":6},"SMA NEGERI 1 NGANJUK","OTHER",[8,14,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Device: Audiovisual Entrainment Neurofeedback (AVE-NFB)",{"label":15,"type":10,"description":16,"interventionNames":17},"Neurofeedback Only","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.",[18],"Device: Neurofeedback Only",{"label":20,"type":10,"description":21,"interventionNames":22},"Audiovisual Entrainment Only","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.",[23],"Behavioral: Audiovisual Entrainment",{"label":25,"type":26,"description":27,"interventionNames":28},"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.",[29],"Behavioral: Sham Control",[31,36,39,44],{"type":32,"name":9,"description":33,"armGroupLabels":34,"otherNames":35},"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.",[9],null,{"type":32,"name":15,"description":37,"armGroupLabels":38,"otherNames":35},"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.",[15],{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":35},"BEHAVIORAL","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.",[20],{"type":40,"name":25,"description":45,"armGroupLabels":46,"otherNames":35},"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.",[25],[48],{"name":49,"affiliation":50,"role":51},"Saraswati Eva Yuswikarini, M.Psi., Psychologist","HIMPSI","STUDY_DIRECTOR",[53,58],{"name":54,"role":55,"phone":56,"phoneExt":35,"email":57},"Daniswara Raditya Suprapto","CONTACT","+6289502459696","daniswara.raditya144@sma.belajar.id",{"name":59,"role":55,"phone":60,"phoneExt":35,"email":61},"Navysa Fatah Onawa","+6281252278367","2411464@magelang.tarunanusantara.sch.id",[63,81],{"facility":64,"status":35,"city":65,"state":66,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"SMA Taruna Nusantara","Magelang","Central Java","56172","Indonesia","ID",{"type":71,"coordinates":72},"Point",[73,74],110.21778,-7.47056,{"lat":74,"lon":73},[77],{"name":78,"role":55,"phone":79,"phoneExt":35,"email":80},"Susilo Tri Atmojo, S.Si","+62 858-7932-7398","susilotn.35@gmail.com",{"facility":82,"status":35,"city":83,"state":84,"zip":85,"country":68,"countryCode":69,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"SMA Negeri 1 Nganjuk","Nganjuk","East Java","64415",{"type":71,"coordinates":87},[88,89],111.9035,-7.6051,{"lat":89,"lon":88},[92],{"name":93,"role":55,"phone":94,"phoneExt":35,"email":95},"Finiswatin S.Pd., M.Pd, Master","+6281235088880","smasa_nganjuk@yahoo.co.id",{"type":97,"investigatorFullName":54,"investigatorTitle":98,"investigatorAffiliation":5,"oldNameTitle":35,"oldOrganization":35},"SPONSOR_INVESTIGATOR","Lead Student Researcher under Supervisor Oversight","100650162","ave-neurofeedback-for-academic-anxiety-and-divergent-thinking-100650162",false,"NCT07745335","AVE-Neurofeedback for Academic Anxiety and Divergent Thinking","Efficacy of a Multisensory Audiovisual Entrainment Neurofeedback for Academic Anxiety Regulation and Divergent Thinking: A Randomized Controlled Trial Study","AVE-NFB","Inclusion Criteria:\n\n* Senior high school students aged 15-18 years.\n* Elevated academic anxiety according to screening assessment.\n* Able to understand study procedures.\n* Willing to provide written informed consent (and parental consent where required).\n\nExclusion Criteria:\n\n* History of epilepsy or seizure disorders.\n* Neurological disorders.\n* Severe psychiatric disorders.\n* Current psychoactive medication affecting EEG activity.\n* Significant visual impairment incompatible with photic stimulation.\n* Previous neurofeedback training within the last six months.",true,"ALL","15 Years","18 Years",{"count":112,"type":113},120,"ESTIMATED","INTERVENTIONAL",[116],"NA","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.\n\nThis 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.\n\nEach 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.\n\nOutcome 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).",[119,120,121],"Academic Anxiety","Test Anxiety","Divergent Thinking",[123,124,125,126,127,128,129],"Closed-Loop Brain-Computer Interface","Neural Oscillation","Alpha-Band Neurofeedback","Neuroplasticity","Cognitive Enhancement","Adolescent Neuroscience","School-Based Intervention","NOT_YET_RECRUITING","2026-08-08",{"date":133,"type":134},"2026-08-11","ACTUAL",{"date":136,"type":113},"2026-08-25",{"date":138,"type":113},"2027-01-01",{"name":54,"class":6},2]