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Study identifier: NCT06616116 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Stress Management with Real-time Bio-signal Biofeedback

Condition: Bipolar Disorder (BD) · Major Depressive Diorder  ·  Sponsor: Seoul National University Hospital

PhaseNA
Planned participants100
Who can joinAll sexes, 15 Years to 59 Years
Healthy volunteersNo

About this study

The goal of this clinical trial is to learn if the real-time bio-signal monitoring device (Neuronicle FX2 device), combined with mindfulness-based cognitive therapy (MBCT), helps manage stress and improves symptoms of mood disorders, such as depression and anxiety. The main questions this study aims to answer are: * Does real-time bio-signal feedback mindfulness using the Neuronicle FX2 reduce perceived stress in participants with mood disorders? * Does it lead to improvements in depressive and anxiety symptoms? Researchers will compare participants receiving real-time biofeedback with the Neuronicle FX2 to those receiving no feedback during mindfulness sessions to see if the device enhances the effectiveness of stress management and symptom improvement. Participants will: * Undergo mindfulness-based cognitive therapy (MBCT) once a week for 8 weeks. * Half of the participants will receive real-time biofeedback using the Neuronicle FX2 device during mindfulness sessions, while the other half will not be provided biofeedback. * Visit the clinic every week for their mindfulness sessions and assessments. * Wear the Neuronicle FX2 device during mindfulness exercises, which will measure brainwave activity (EEG) and heart rate variability (HRV). * Participate in assessments before, during, and after the program (8wks, 16wks) to evaluate their stress, depression, and anxiety levels.

This description comes directly from the study's public registry record.

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Contact details are listed per location below or on the registry record.

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Locations (1)

Seoul National University HospitalSeoul, Jongno-gu, South KoreaRecruiting

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Source record: clinicaltrials.gov/study/NCT06616116