NCT06616116Completed
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
Source: ClinicalTrials.gov · Last updated 23 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 140 (actual)
- First submitted
- 6 Sept 2024
- Start date
- 13 Jun 2024
- Primary completion date
- 11 Jun 2026
- Lead sponsor
- Seoul National University Hospital
- Diseases
- Depression, Bipolar disorder
- NCT number
- NCT06616116
What you commit to
- Study type: Interventional
- Participants enrolled: 140
- From 13 Jun 2024 to the primary completion date, 11 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Other illness
- 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 co-occurring personality disorders (e.g., borderline personality disorder, antisocial personality disorder, narcissistic personality disorder).
- 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).
Other
- Individuals with acute suicidal ideation.
- Individuals with medical, psychological, social, or legal issues that would interfere with continued participation in the program.
Who the study is looking for
- 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.
Age in the registry: 15 years to 59 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.