- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07582692
Sequential Prefrontal Alpha-Theta Neurofeedback on Abstinence Self-Efficacy, Mindfulness, and EEG in Alcohol Use Disorder (NFB-AUD)
May 11, 2026 updated by: Yerin Hong, Seoul University of Buddhism
Effects of Sequential Prefrontal Alpha-Theta Neurofeedback Training on Abstinence Self-Efficacy, Mindfulness, and EEG in Alcohol Use Disorder
This study examined the effects of sequential prefrontal alpha-theta neurofeedback training on abstinence self-efficacy, mindfulness, and brain electroencephalography (EEG) activity in adults with Alcohol Use Disorder (AUD).
Participants in the experimental group received 24 sessions of neurofeedback over 8 weeks (3 sessions per week, 30 minutes per session), while a control group received no intervention.
EEG and self-report measures were assessed at baseline and post-intervention.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
17
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Seoul, South Korea
- Neurofeedback Training Centre
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Adults diagnosed with Alcohol Use Disorder (AUD) according to Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) criteria
- Alcohol Use Disorders Identification Test-Korean (AUDIT-K) score >= 20 (males) or >= 10 (females) indicating high-risk drinking
- Voluntary written informed consent
Exclusion Criteria:
- Sensory impairment (visual or auditory)
- Diagnosis of intellectual disability
- Current use of antipsychotics, central nervous system stimulants, or sedatives
- Active neurological conditions (e.g., epilepsy, recent traumatic brain injury)
- Severe psychiatric comorbidities (e.g., active psychosis) contraindicated for EEG-based neurofeedback
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Sequential Prefrontal Alpha-Theta Neurofeedback
24 sessions of sequential prefrontal alpha-theta neurofeedback training over 8 weeks (3 sessions/week, 30 min/session).
Each session: 5 min alpha feedback (8-12 hertz [Hz]) followed by 25 min theta feedback (4-7 Hz) at Fp1/Fp2, delivered via ocean wave and birdsong audio while eyes closed.
Device: Power Nap (Neuro21, Korea).
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Operant conditioning-based neurofeedback: 5 min alpha (8-12 Hz) + 25 min theta (4-7 Hz) at prefrontal sites Fp1/Fp2 per session; 24 sessions over 8 weeks supervised by a certified practitioner.
Audio feedback (ocean waves for alpha, birdsong for theta) delivered via Power Nap device (Neuro21, Korea) while participants remained eyes-closed and seated.
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No Intervention: Control - No Intervention
Participants continued usual daily activities for 8 weeks without any intervention.
Pre- and post-test assessments (EEG and self-report measures) were conducted.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Abstinence Self-Efficacy
Time Frame: Baseline (Week 0) and post-intervention (Week 8)
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Total score on the Alcohol Abstinence Self-Efficacy Scale (AASE; Korean adaptation), a 20-item scale with four subscales (Negative Affect, Social/Positive Emotions, Physical and Other Concerns, Withdrawal and Urges), each rated 0-4; higher scores indicate greater confidence in maintaining abstinence.
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Baseline (Week 0) and post-intervention (Week 8)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mindfulness
Time Frame: Baseline (Week 0) and post-intervention (Week 8)
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Total score on the Mindfulness Scale (20 items, 4 subscales: Decentered Attention, Nonjudgmental Acceptance, Present-Moment Awareness, Attentional Focus), rated 1-5 (reverse-scored); higher scores indicate greater mindfulness.
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Baseline (Week 0) and post-intervention (Week 8)
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EEG Relative Power
Time Frame: Baseline (Week 0) and post-intervention (Week 8)
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Relative spectral power (% of total power) across delta (1-4 Hz), theta (4-8 Hz), alpha (8-12 Hz), beta (13-30 Hz), and sensorimotor rhythm (SMR; 12-15 Hz) bands at prefrontal sites (Fp1, Fp2), measured using eyes-closed resting EEG with the NeuroBrain system.
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Baseline (Week 0) and post-intervention (Week 8)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2024
Primary Completion (Actual)
September 25, 2024
Study Completion (Actual)
September 25, 2024
Study Registration Dates
First Submitted
May 5, 2026
First Submitted That Met QC Criteria
May 11, 2026
First Posted (Actual)
May 13, 2026
Study Record Updates
Last Update Posted (Actual)
May 13, 2026
Last Update Submitted That Met QC Criteria
May 11, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 27004121AN01-202406-HR-080-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.