Actively Recruiting
Stress Management with Real-time Bio-signal Biofeedback
Led by Seoul National University Hospital · Updated on 2024-09-27
100
Participants Needed
1
Research Sites
80 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Stress Management with Real-time Bio-signal Biofeedback
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 15 and 59 years
- Diagnosed with mood disorders like bipolar disorder or major depressive disorder according to DSM-5
- Presence of anxiety symptoms alongside mood disorder
- Perceived Stress Scale score of 10 or higher
- Ability to independently complete questionnaires and communicate in Korean
- Willingness to participate voluntarily in weekly treatment sessions
You will not qualify if you...
- Diagnosis of major psychiatric disorders other than mood disorders (e.g., schizophrenia, substance use disorders, obsessive-compulsive disorder)
- Current acute psychotic symptoms or manic state in bipolar disorder
- Acute suicidal thoughts
- Co-occurring personality disorders such as borderline, antisocial, or narcissistic personality disorder
- Participation in mindfulness-based cognitive therapy within the last 3 months
- Currently receiving other non-drug treatments like cognitive-behavioral therapy or psychoanalysis
- Neurological damage or brain injury conditions (e.g., seizure disorder, brain lesions, neurodegenerative disorders, serious head trauma)
- Cardiovascular diseases including hypertension, coronary artery disease, or arrhythmia
- Hearing impairment or tinnitus
- Impaired ability to understand the study or make decisions (e.g., IQ below 70 or dementia)
- Medical, psychological, social, or legal issues that could interfere with study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Seoul National University Hospital
Seoul, Jongno-gu, South Korea, 03080
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here