NCT06616116Befejeződött
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 23.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Befejeződött
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 140 (tényleges)
- Első benyújtás
- 2024. szept. 6.
- Kezdés
- 2024. jún. 13.
- Elsődleges befejezés
- 2026. jún. 11.
- Fő szponzor
- Seoul National University Hospital
- Betegségek
- Bipoláris zavar, Depresszió
- NCT-szám
- NCT06616116
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Bevont résztvevők: 140
- 2024. jún. 13. és az elsődleges befejezés (2026. jún. 11.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- 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).
Más betegség
- 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).
Egyéb
- Individuals with acute suicidal ideation.
- Individuals with medical, psychological, social, or legal issues that would interfere with continued participation in the program.
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 15 év – 59 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Seoul National University Hospital | Seoul | Dél-Korea | Ismeretlen állapot |
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