NCT06616116 Stress Management with Real-time Bio-signal Biofeedback
| NCT ID | NCT06616116 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Seoul National University Hospital |
| Condition | Bipolar Disorder (BD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-06-13 |
| Primary Completion | 2025-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2024-06-13 with a primary completion date of 2025-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Frequently Asked Questions
Who can join the NCT06616116 clinical trial?
This trial is open to participants of all sexes, aged 15 Years or older, up to 59 Years, studying Bipolar Disorder (BD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06616116 currently recruiting?
Yes, NCT06616116 is actively recruiting participants. Visit ClinicalTrials.gov or contact Seoul National University Hospital to inquire about joining.
Where is the NCT06616116 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT06616116 clinical trial?
NCT06616116 is sponsored by Seoul National University Hospital. The trial plans to enroll 100 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.