- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07860489
Neurofeedback Therapy Added to Cognitive Behavioural Therapy-Based Psychoeducation for Test Anxiety Among Undergraduate Students: A Randomised Controlled Trial
The goal of this clinical trial was to learn whether adding neurofeedback therapy to cognitive behavioural therapy (CBT)-based psychoeducation could reduce test anxiety in university students more than CBT-based psychoeducation alone.
The main questions it aimed to answer were:
- Did adding neurofeedback to CBT-based psychoeducation produce a greater reduction in test anxiety than CBT-based psychoeducation alone?
- Did test anxiety levels change from before the intervention to the middle and end of the intervention period?
Researchers compared two groups. One group received CBT-based psychoeducation together with neurofeedback training, while the other group received CBT-based psychoeducation alone. Participants were randomly assigned to one of the two groups.
Participants:
- Completed screening for test anxiety using the Westside Test Anxiety Scale (WTAS).
- Completed the Test Anxiety Inventory (TAI) before, during, and after the intervention.
- Received CBT-based psychoeducation on test anxiety and coping strategies.
- Participants assigned to the neurofeedback group also completed a baseline EEG assessment and received 10 sessions of EEG-based neurofeedback training targeting high-beta2 activity at the F4 electrode site.
- Practised CBT-based coping strategies during the intervention period.
The main outcome was change in Test Anxiety Inventory scores across the three assessment points and whether the pattern of change differed between the two study groups.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
This study used a two-arm, parallel-group randomised controlled design to examine the incremental effect of adding electroencephalography (EEG)-based neurofeedback to cognitive behavioural therapy (CBT)-based psychoeducation for test anxiety among undergraduate students. Participants were randomly allocated in a 1:1 ratio to either CBT-based psychoeducation combined with neurofeedback or CBT-based psychoeducation alone. The study was conducted at the International Islamic University Malaysia, with neurofeedback and EEG procedures delivered at the Neurocoach Digital Lab, KICT, IIUM.
Both study groups received the same CBT-based psychoeducation programme. The programme introduced the cognitive-behavioural model of test anxiety and strategies for managing examination-related thoughts and physiological arousal, including cognitive restructuring, deep breathing, progressive muscle relaxation, and structured self-monitoring and was conducted by a registered clincial psychologist and assisted by a co-investigator. The experimental group subsequently received additional neurofeedback training over approximately four weeks. The groups therefore differed in exposure to neurofeedback, while the CBT-based psychoeducation component was held constant across conditions.
Before neurofeedback training, participants allocated to the experimental group underwent a 19-channel quantitative EEG assessment under eyes-closed, eyes-open, and cognitive-task conditions. Neurofeedback training used a standardized high-beta2 inhibition protocol targeting the F4 electrode site. Training was delivered using the BrainMarker EXG system, with real-time feedback provided according to participants' EEG activity relative to the training threshold. Test anxiety assessments were conducted before the intervention, during the intervention period, and after completion of the intervention to examine changes over time and differences in change between the two study groups
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Selangor
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Kuala Lumpur, Selangor, Malaysia, 50728
- Neurocoach Digital Lab Kulliyyah of Information & Communication Technology
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- (1) IIUM undergraduate students aged 19-24 years,
- (2) achieve a baseline score of ≥ 3.0 on the Westside Test Anxiety Scale (WTAS)
- (3) Provide informed consent to participate in the study
- (4) Be willing to attend EEG assessment and neurofeedback sessions for the experimental group.
Exclusion Criteria:
- (1) Clinically diagnosed with a neurological disorder, severe psychiatric condition, or any disabilities that may affect EEG recordings
- (2) Have received CBT and neurofeedback (NFB) therapy in the past or are currently receiving it
- (3) Currently receiving psychological treatment for anxiety and
- (4) Unable to attend the required intervention sessions.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Neurofeedback + Cognitive Behavioural Therapy-based Psychoeducation
Participants in this arm receive electroencephalography (EEG)-based neurofeedback training sessions in combination with Cognitive Behavioural Therapy (CBT)-based psychoeducation modules designed to reduce test anxiety among undergraduate students. |
Electroencephalography (EEG)-based neurofeedback training sessions are designed to evaluate real-time brainwave activity and assist participants in self-regulating neural activities associated with stress and test anxiety among undergraduate students. Structured psychoeducational modules based on Cognitive Behavioural Therapy (CBT) principles, designed to help undergraduate students identify, understand, and modify unhelpful cognitive distortions and behavioral responses related to test anxiety. |
|
Comparatore attivo: Cognitive Behavioural Therapy-based Psychoeducation
Structured psychoeducational modules based on Cognitive Behavioural Therapy (CBT) principles, designed to help undergraduate students identify, understand, and modify unhelpful cognitive distortions and behavioral responses related to test anxiety. |
Structured psychoeducational modules based on Cognitive Behavioural Therapy (CBT) principles, designed to help undergraduate students identify, understand, and modify unhelpful cognitive distortions and behavioral responses related to test anxiety. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Test Anxiety Inventory (TAI) Total Score Across Pre-, Mid-, and Post-Intervention
Lasso di tempo: Baseline (pre-intervention), approximately 2 weeks after intervention initiation (mid-intervention), and approximately 4 weeks after intervention initiation (post-intervention).
|
Test anxiety was measured using the 20-item Test Anxiety Inventory (TAI). Each item is rated on a 4-point Likert scale, producing a total score ranging from 20 to 80, with higher scores indicating greater test anxiety. The primary outcome was change in TAI total score across three assessment points: pre-intervention, mid-intervention, and post-intervention. The analysis examined whether TAI scores changed over time and whether the pattern of change differed between participants receiving neurofeedback plus CBT-based psychoeducation and those receiving CBT-based psychoeducation alone. |
Baseline (pre-intervention), approximately 2 weeks after intervention initiation (mid-intervention), and approximately 4 weeks after intervention initiation (post-intervention).
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Jamilah Hanum binti Abdul Khaiyom (Assoc. Prof. Dr.), Psychology, International Islamic University Malaysia
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- SPI26-321-0321
- Southern Ambition 473cc (Altro numero di sovvenzione/finanziamento: Southern Ambition 473cc)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Westside Test Anxiety Scale (WTAS) Test Anxiety Inventory (TAI) Scores Demographic Information
Periodo di condivisione IPD
Data will be available following publication of the primary study results and for a period of 5 years, subject to institutional data-retention requirements.
Criteri di accesso alla condivisione IPD
Data will be available to qualified researchers for legitimate academic research purposes upon submission of a reasonable request to the corresponding author. Requests will be reviewed by the research team and, where applicable, the Neurocoach Digital Lab. Data will be shared only after approval and in accordance with participant consent, ethical requirements, and institutional data-sharing policies.
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- ICF
Informazioni su farmaci e dispositivi, documenti di studio
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