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Life sciences · Interventional Study
ClinicalTrials.gov · October 23, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT06616116). This is a study registration, not published results. Lead sponsor: Seoul National University Hospital. Recruitment status: COMPLETED. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 140 participants (ACTUAL). Conditions: Bipolar Disorder (BD), Major Depressive Diorder. Interventions: DEVICE: Biosignal feedback; DEVICE: Sham Comparator. Primary outcome measures: Changes from baseline Korean Perceived Stress Scale (K-PSS) score at 8wks, and 16 wks , Baseline (pre-treatment), immediately after the 8-week intervention, and at 2-month follow-up.. Brief summary: 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.