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Neurofeedback-Assisted Mindfulness Techniques to Reduce Symptoms of Mental Distress - Trial NCT06208787

Access comprehensive clinical trial information for NCT06208787 through Pure Global AI's free database. This phase not specified trial is sponsored by KU Leuven and is currently Recruiting. The study focuses on Stress. Target enrollment is 80 participants.

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NCT06208787
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behavioral
Trial Details
ClinicalTrials.gov โ€ข NCT06208787
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Neurofeedback-Assisted Mindfulness Techniques to Reduce Symptoms of Mental Distress
Combining Novel Bio-Neurofeedback Techniques With Mindfulness-Based Interventions to Reduce Symptoms of Mental Distress

Study Focus

Stress

Neurofeedback training

Interventional

behavioral

Sponsor & Location

KU Leuven

Leuven, Belgium

Timeline & Enrollment

N/A

Jan 08, 2024

Jun 06, 2025

80 participants

Primary Outcome

occurrence of non-harmonic alpha-theta ratios at rest,occurrence of non-harmonic alpha-theta ratios during meditation,occurrence of non-harmonic alpha-theta ratios during stress induction,occurrence of non-harmonic alpha-theta ratios during stress recovery,self-reported levels of emotional distress

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.

ICD-10 Classifications

Stress, not elsewhere classified
Other reactions to severe stress
Reaction to severe stress, unspecified
Undue concern and preoccupation with stressful events
State of emotional shock and stress, unspecified

Data Source

ClinicalTrials.gov

NCT06208787

Non-Device Trial