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

Inclusion Criteria6

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 Criteria11

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 personality disorder).
Individuals who have participated in mindfulness-based cognitive therapy within the last 3 months.
Individuals currently receiving other non-pharmacological treatments (e.g., cognitive-behavioral therapy, psychoanalysis).
Individuals with neurological damage or conditions that may cause brain injury (e.g., seizure disorder, cerebrovascular or neoplastic lesion, neurodegenerative disorder, significant head trauma with loss of consciousness lasting more than 5 minutes).
Individuals diagnosed with cardiovascular diseases (e.g., hypertension, coronary artery disease, arrhythmia).
Individuals with hearing impairment or tinnitus.
Individuals with impaired ability to understand the study's purpose or make decisions about participation (e.g., IQ \< 70, dementia).
Individuals with medical, psychological, social, or legal issues that would interfere with continued participation in the program.

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