The effect of brainwave-based feedback on anxiety and stress in college students
| ISRCTN | ISRCTN40165598 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40165598 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | PID 205866 |
| Sponsor | Affiliated Psychological Hospital, Anhui Medical University |
| Funder | Anhui Provincial Key Research and Development Plan |
- Submission date
- 14/10/2025
- Registration date
- 16/10/2025
- Last edited
- 15/10/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
College students commonly face anxiety and stress issues, yet there is currently a lack of real-time, non-invasive monitoring and intervention methods. This study aims to explore, through two experiments, the capability of electroencephalogram (EEG) in predicting stress biomarkers (such as cortisol and alpha-amylase) and anxiety states, and to develop an EEG-based closed-loop neurofeedback training system to help individuals with anxiety regulate their emotions and alleviate symptoms.
Who can participate?
1. Anxiety Disorder Participants: College students aged 17-30 with current anxiety symptoms only, no history of other mental disorders, and no current use of psychiatric medications.
2. Healthy Participants: College students aged 17-30 with no history of mental or psychological disorders and no significant physical illnesses.
All participants must have normal vision and hearing (or corrected to normal) and sign an informed consent form.
What does the study involve?
Study 1: Participants will complete a modified version of the Montreal Stress Test, with the core task being mental arithmetic training. The experimental group will perform the task under time pressure, while the control group will have no time constraints. Electroencephalogram (EEG) data will be recorded simultaneously, and saliva samples will be collected for analysis of cortisol and alpha-amylase levels.
Study 2: Participants were randomly assigned to two groups: The experimental group received EEG-based closed-loop neurofeedback training to learn negative emotion suppression through real-time feedback during an emotional image recognition task. The control group performed the same task without receiving neurofeedback. All participants completed anxiety scale assessments and EEG recordings both before and after the intervention.
What are the potential benefits and risks of participation?
Potential Benefits:
1. Helps participants better understand and regulate their emotional states;
2. Accesses professional psychological assessments and EEG monitoring;
3. May alleviate anxiety symptoms and enhance emotional regulation skills.
Potential Risks:
1. Temporary discomfort or anxiety caused by task pressure during the experiment;
2. Mild discomfort from wearing EEG devices;
3. Some participants may experience fatigue or cognitive load during training.
Where is the study conducted?
Hefei Fourth People's Hospital (Anhui Mental Health Center) (China)
When does the study start and how long is it expected to last?
January 2022 to December 2027
Who is funding this research?
Anhui Province Key Research and Development Program Project (China)
Who is the main contact?
Wan Li, wanli@ahmu.edu.cn
Contact information
Public, Scientific, Principal investigator
No.316 Huangshan Road, Shushan District, Hefei City, Anhui Province
Hefei
230026
China
| Phone | +86 (0)55163616273 |
|---|---|
| wanli@ahmu.edu.cn |
Public
No.316 Huangshan Road, Shushan District, Hefei City, Anhui Province
Hefei
230026
China
| 0009-0003-8986-9035 | |
| Phone | +86 18855183148 |
| 2230577076@qq.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A randomised controlled trial of a closed-loop EEG neurofeedback intervention for anxiety: targeting emotion regulation and event-related potential biomarkers |
| Study objectives | Experiment 1 aims to explore the predictive capability of EEG feature models for cortisol and α-amylase levels by integrating different machine learning models and feature importance analysis methods, with the goal of providing novel solutions for real-time, non-invasive stress monitoring. Experiment 2 aims to focus on specific ERP components during states of anxiety and to explore a brainwave feature model capable of monitoring and predicting anxiety states (diagnostic model). |
| Ethics approval(s) |
Approved 05/01/2023, Medical Research Ethics Committee of Hefei Fourth People's Hospital (316 Huangshan Road, Shushan District, Hefei, 230026, China; +86 (0)551 6361 6193; 2514331322@qq.com), ref: HFS-IRB-PJ-WL (2022002) |
| Health condition(s) or problem(s) studied | Anxiety disorder |
| Intervention | Study 1: The participants underwent two identical experimental procedures: Day 1: the first montreal imaging stress task (MIST) with EEG recording. Day 4: the second MIST task with EEG recording. The MIST task included four 3-minute blocks: the first and third blocks were control blocks and the second and forth blocks were experimental blocks , with saliva collection completion after each block. A final saliva collection was completed after a 15-minute rest. Saliva was collected six times: after MIST training (following a 5-minute rest) and at the end of each 3-minute block (four times), with a final collection after a 15-minute rest. A total of 12 saliva samples were collected before and after the intervention (Figure 1). Saliva samples were collected via standardized time points, cryopreserved at -80°C, and tested for cortisol and alpha-amylase levels using kits. Study 2: All participants were randomly assigned to one of the following two groups: Experimental group (n=30): Participants exhibiting anxiety symptoms receive closed-loop neurofeedback training based on electroencephalogram (EEG). During training, participants performed an emotion image recognition task (positive/negative) while actively suppressing negative emotions triggered by viewing negative images. Task-related EEG signals were collected in real-time, and real-time neural feedback was provided based on event-related potential components (e.g., N2/P3/LPP). Each training session lasted approximately 30 minutes, with multiple sessions conducted (specific number determined by experimental design). Control group (n=30): Received identical intervention content to the experimental group but without neural feedback. Participants performed the same emotion image recognition task while EEG data was collected. All participants completed clinical scale assessments (e.g., Self-Rating Anxiety Scale) and baseline EEG recordings prior to intervention. EEG data collection and scale assessments were repeated post-intervention. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Study 1: |
| Key secondary outcome measure(s) |
Study 1: |
| Completion date | 31/12/2027 |
Eligibility
| Participant type(s) | Learner/student |
|---|---|
| Age group | Adult |
| Lower age limit | 17 Years |
| Upper age limit | 30 Years |
| Sex | All |
| Target sample size at registration | 60 |
| Key inclusion criteria | Anxiety disorder participants: 1. Age 17-30 years old college students; 2. Able to comprehend questionnaire content and complete all scales independently; 3. Currently experiencing only anxiety symptoms without other DSM-5-confirmed mental disorders; 4. No history of psychiatric medication use (within 6 months); 5. Normal vision and hearing or corrected vision/hearing; 6. No severe physical illnesses, no history of head trauma, no metal implants in the head, no epilepsy, no episodes of transient loss of consciousness; willing to participate and have signed an informed consent form. Healthy participants: 1. Age 17-30 years old college students 2. Normal hearing, normal or corrected vision 3. Right-handed 4. No previous diagnosis of mental or psychological illness 5. No history of major physical illness |
| Key exclusion criteria | Exclusion criteria for anxiety disorders: 1. The questionnaire results contain significant logical inconsistencies; 2. Confirmed diagnosis of mental illness or family history of psychiatric disorders; 3. History of head trauma or implanted devices in the head; 4. If participants show marked improvement in anxiety levels or nearly perfect scores during closed-loop training before the assessment, they may be preliminarily excluded from the anxiety group as they may not meet the diagnostic criteria for anxiety. |
| Date of first enrolment | 02/03/2023 |
| Date of final enrolment | 15/04/2024 |
Locations
Countries of recruitment
- China
Study participating centre
Shushan District
Hefei
230032
China
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Wan Li (wanli@ahmu.edu.cn) after the publication of the article |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
15/10/2025: Trial's existence confirmed by Medical Research Ethics Committee of Hefei Fourth People's Hospital.