NCT07582692

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2024

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

May 5, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 13, 2026

Completed
Last Updated

May 13, 2026

Status Verified

May 1, 2026

Enrollment Period

3 months

First QC Date

May 5, 2026

Last Update Submit

May 11, 2026

Conditions

Keywords

neurofeedbackEEGabstinence self-efficacymindfulnessalpha-theta

Outcome Measures

Primary Outcomes (1)

  • Abstinence Self-Efficacy

    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.

    Baseline (Week 0) and post-intervention (Week 8)

Secondary Outcomes (2)

  • Mindfulness

    Baseline (Week 0) and post-intervention (Week 8)

  • EEG Relative Power

    Baseline (Week 0) and post-intervention (Week 8)

Study Arms (2)

Sequential Prefrontal Alpha-Theta Neurofeedback

EXPERIMENTAL

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).

Behavioral: Sequential Prefrontal Alpha-Theta Neurofeedback Training

Control - No Intervention

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.

Interventions

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.

Sequential Prefrontal Alpha-Theta Neurofeedback

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neurofeedback Training Centre

Seoul, South Korea

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 5, 2026

First Posted

May 13, 2026

Study Start

July 1, 2024

Primary Completion

September 25, 2024

Study Completion

September 25, 2024

Last Updated

May 13, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations