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RecruitingNCT06616116

Stress Management with Real-time Bio-signal Biofeedback

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Plain-language summary for patients

Trial Parameters

ConditionBipolar Disorder (BD)
SponsorSeoul National University Hospital
Study TypeINTERVENTIONAL
PhaseN/A
Enrollment100
SexALL
Min Age15 Years
Max Age59 Years
Start Date2024-06-13
Completion2025-06-30
Interventions
Biosignal feedbackSham Comparator

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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.

Eligibility Criteria

Inclusion Criteria: * Individuals aged 15 to 59 years. * Patients diagnosed with mood disorders (e.g., bipolar disorder, major depressive disorder) through screening and clinician interviews, according to DSM-5. * Patients with accompanying anxiety symptoms. * Patients with stress symptoms (Perceived Stress Scale score ≥ 10) * Individuals able to independently complete questionnaires and communicate in Korean. * Individuals who voluntarily agree to participate in weekly treatment sessions. Exclusion Criteria: * Patients diagnosed with major psychiatric disorders other than mood disorders (e.g., schizophrenia, substance use disorders including alcohol, obsessive-compulsive disorder). * Patients diagnosed with bipolar disorder who are currently experiencing acute psychotic symptoms or are in a manic state. * Individuals with acute suicidal ideation. * Individuals with co-occurring personality disorders (e.g., borderline personality disorder, antisocial personality disorder, narcissistic

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