Stress Management with Real-time Bio-signal Biofeedback

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-59
SponsorSeoul National University Hospital

About this trial

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

Qualifiers

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)

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • Biosignal feedback
  • Sham Comparator

Treatment groups

100 Participants
are divided into 2 treatment groups