RecruitingNot ApplicableNCT06616116

Stress Management with Real-time Bio-signal Biofeedback

Development and Verification of Effectiveness of Biofeedback Contents for Stress Management Using Real-time Bio-signal Monitoring Device

Sponsor

Seoul National University Hospital

Enrollment

100 participants

Start Date

Jun 13, 2024

Study Type

INTERVENTIONAL

Conditions

Bipolar Disorder (BD)Major Depressive Diorder

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

Min Age: 15 YearsMax Age: 59 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether real-time biofeedback technology — which uses wearable sensors to show people their own body signals like heart rate and skin response — can help people with mood disorders (depression or bipolar disorder) better manage stress and anxiety. **You may be eligible if...** - You are between 15 and 59 years old - You have been diagnosed with a mood disorder (such as bipolar disorder or major depressive disorder) based on DSM-5 criteria - You also have anxiety symptoms - Your perceived stress level is moderate or above (score of 10 or higher on the Perceived Stress Scale) - You are able to independently fill out questionnaires **You may NOT be eligible if...** - You are in an acute psychiatric crisis requiring hospitalization - You have severe cognitive impairment preventing active participation - You have a medical condition preventing you from using wearable sensors - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEBiosignal feedback

1. Real-time neurofeedback guided mindfulness : Unlike standard mindfulness therapies, this intervention integrates real-time monitoring of brainwave activity (EEG). Participants in the experimental group receive immediate auditory feedback during their mindfulness sessions, which helps guide their practice and enhance engagement. 2. Tailored progress report In addition to real-time feedback, participants in the Mindfulness with biosignal feedback group receive detailed reports of their biosignal data (EEG and HRV) before, during, and after each session. These reports allow for deeper self-reflection and personalized adjustments to their mindfulness practice, which is not commonly provided in other mindfulness programs.

DEVICESham Comparator

Biosignal Monitoring (EEG and HRV) during Mindfulness without real-time feedback