Neurofeedback-Assisted Mindfulness Techniques to Reduce Symptoms of Mental Distress

NCT06208787 | Completed

• 1 other identifier: S68049
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Neurofeedback training, based on operant conditioning techniques, involves the measurement and conscious regulation of specific neural parameters through participant-specific feedback. This technique has gained recognition for its role in efficiently altering brain activity. Among its various applications, neurofeedback training is noted for its ability to facilitate meditative practice and enhance stress regulation abilities. However, most neurofeedback studies focus on modulating isolated brainwaves and overlook how brainwaves interact across frequencies. To address this gap, the present study will evaluate an intervention that combines meditation techniques with a novel cross-frequency neurofeedback training to enhance the outcomes of meditative practice for stress regulation. Previous research has established that brain rhythms exhibit interactive patterns, forming harmonic and non-harmonic relationships to respectively facilitate and preclude cross-frequency coupling. Harmonic relationships are essential for the synchronization of oscillations, a process necessary for coordinating complex neural and physiological activities. In contrast, non-harmonic relationships result in a highly desynchronized state characterized by reduced neural and physiological coordination, typically observed during cognitive restful periods. In this regard, prior studies have demonstrated a link between an increased occurrence of non-harmonic alpha-theta ratios and mindfulness meditation. Recent research has shown the possibility of upregulating the incidence of non-harmonic alpha-theta ratios during mindfulness meditation in a single-session neurofeedback training context. However, the impact of long-term training on stress regulation abilities remains unclear. The current study addresses this gap by conducting a 10-session neurofeedback training focused on upregulating the incidence of non-harmonic alpha-theta ratios during focused attention meditation. The primary aim of this study is to determine the effectiveness of this training in assisting mindfulness practice and improving stress regulation as assessed by a range of neurophysiological, psychological, and biological outcomes.

Conditions

Stress

Keywords

neurofeedback; mindfulness; stress; cross-frequency

Outcome Measures

Primary Outcomes (5)

• occurrence of non-harmonic alpha-theta ratios at rest

  EEG recording

  pre-intervention (week 0), post-intervention (week 6), follow-up (week 11)

• occurrence of non-harmonic alpha-theta ratios during meditation

  EEG recording

  pre-intervention (week 0), post-intervention (week 6), follow-up (week 11)

• occurrence of non-harmonic alpha-theta ratios during stress induction

  EEG recording

  pre-intervention (week 0), post-intervention (week 6), follow-up (week 11)

• occurrence of non-harmonic alpha-theta ratios during stress recovery

  EEG recording

  pre-intervention (week 0), post-intervention (week 6), follow-up (week 11)

• self-reported levels of emotional distress

  DASS questionnaire

  pre-intervention (week 0), post-intervention (week 6), follow-up (week 11)

Secondary Outcomes (4)

• self-reported levels of mindfulness skills

  pre-intervention (week 0), post-intervention (week 6), follow-up (week 11)

• self-reported levels of perceived stress

  pre-intervention (week 0), post-intervention (week 6), follow-up (week 11)

• self-reported levels of repetitive negative thinking

  pre-intervention (week 0), post-intervention (week 6), follow-up (week 11)

• self-reported levels of sleep quality

  pre-intervention (week 0), post-intervention (week 6), follow-up (week 11)

Other Outcomes (7)

• salivary oxytocin levels

  pre-intervention (week 0), post-intervention (week 6), follow-up (week 11)

• salivary cortisol levels

  pre-intervention (week 0), post-intervention (week 6), follow-up (week 11)

• mood in daily life

  pre-intervention (week 0), post-intervention (week 6), follow-up (week 11)

Study Arms (2)

Experimental group

EXPERIMENTAL

Individuals assigned to this group will receive the experimental neurofeedback training

Behavioral: Neurofeedback training

Control group

SHAM COMPARATOR

Individuals assigned to this group will receive the sham neurofeedback training

Behavioral: Sham Training

Interventions

Neurofeedback training BEHAVIORAL

Neurofeedback training involving auditory feedback upon measurement of non-harmonic alpha-theta ratios during focused attention meditation

Experimental group

Sham Training BEHAVIORAL

Sham neurofeedback involving auditory feedback at random timepoints during focused attention meditation such that no learning can take place

Control group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Provided written informed consent;
• Dutch or English speaking;
• Experience mild to severe stress symptoms (as measured by a score between 15 and 33 on the Stress Subscale of the DASS-21).

You may not qualify if:

• History of psychotropic medication usage in the past six months;
• Substantial experience with meditative practices (including but not limited to mindfulness, yoga, tai chi, or other similar practices) by meeting any of the following criteria:
• Participant has participated in a multi-day meditation retreat or program during the past year;
• Participant engages in meditative practices on a weekly basis or more frequently, for at least six consecutive weeks, within six month prior to the study.

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

KU Leuven

Leuven, Vlaams Brabant, 3000, Belgium

Location

Study Officials

• Kaat Alaerts, PhD

  KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: January 17, 2024
• Study Start: January 8, 2024
• Primary Completion: August 8, 2025
• Study Completion: August 8, 2025
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)