- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상태
상세 설명
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
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Selangor
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Kuala Lumpur, Selangor, 말레이시아, 50728
- Neurocoach Digital Lab Kulliyyah of Information & Communication Technology
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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. |
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활성 비교기: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Test Anxiety Inventory (TAI) Total Score Across Pre-, Mid-, and Post-Intervention
기간: 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).
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Jamilah Hanum binti Abdul Khaiyom (Assoc. Prof. Dr.), Psychology, International Islamic University Malaysia
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- SPI26-321-0321
- Southern Ambition 473cc (기타 보조금/기금 번호: Southern Ambition 473cc)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Westside Test Anxiety Scale (WTAS) Test Anxiety Inventory (TAI) Scores Demographic Information
IPD 공유 기간
Data will be available following publication of the primary study results and for a period of 5 years, subject to institutional data-retention requirements.
IPD 공유 액세스 기준
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.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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