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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 15
Maximum Age: 59
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Republic of Korea
Seoul National University Hospital
RECRUITING
Seoul
Time Frame
Start Date: 2024-06-13
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 100
Treatments
Experimental: Mindfulness with biosignal feedback
Biosignal Monitoring (EEG and HRV) with Real-time neurofeedback during Mindfulness
Sham_comparator: Mindfulness without biosignal feedback
Biosignal Monitoring (EEG and HRV) without Real-time neurofeedback during Mindfulness
Related Therapeutic Areas
Sponsors
Leads: Seoul National University Hospital

This content was sourced from clinicaltrials.gov