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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Biosignal feedback
Device1. 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.
Sham Comparator
DeviceBiosignal Monitoring (EEG and HRV) during Mindfulness without real-time feedback
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Mindfulness with biosignal feedbackExperimental treatment 1 intervention
Group B: Mindfulness without biosignal feedbackSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Changes from baseline Korean Perceived Stress Scale (K-PSS) score at 8wks, and 16 wks
The full name: Perceived Stress Scale - 10 item form 14-item scale developed by Cohen et al. (1983) that emphasizes subjective perception of stress. Measures the degree of perceived unforeseeable, uncontrollable, and overwhelming experience of stress in the past month. Although the 14-item PSS tend to exhibit good reliability, four of the items tend to perform poorly when evaluated using exploratory factor analysis (Cohen et al., 1988). As a result, the PSS is commonly implemented using the 10-item form. The questions are rated on 5-point Likert scale; 0 (never), 1 (almost never), 2 (sometimes), 3 (fairly often), 4 (very often). Higher scores represent worse outcomes. The scores of each scale sum into the total score. Thus the total score ranges from 0 to 40.
Time frame
Baseline (pre-treatment), immediately after the 8-week intervention, and at 2-month follow-up.Secondary outcomes
1
Change from baseline Inventory of Depressive Symptomatology (IDS-SR) score
The Inventory of Depressive Symptomatology-Self Report (IDS-SR) is a self-report questionnaire used to assess the severity of depressive symptoms. It was developed to provide a comprehensive evaluation of various dimensions of depression, including mood, cognition, behavior, and physical symptoms. IDS-SR16 version is used for this study: A shorter, 16-item version focusing on core depressive symptoms.
Time frame
Baseline, immediately after the 8-week intervention, and at 2-month follow-up.2
Change from baseline Hamilton depression rating scale (HAM-D) score
The Hamilton Depression Rating Scale (HAM-D) is a 17-item assessment tool used by interviewers to evaluate the severity of depressive symptoms. According to the reliability and validation study of the Korean version, the internal consistency reliability was 0.76. The total score ranges from 0 to 52, with higher scores indicating more severe depression.
Time frame
Baseline, immediately after the 8-week intervention, and at 2-month follow-up.3
Change from baseline Hamilton anxiety rating scale (HAM-A) score
The Hamilton Anxiety Rating Scale (HAM-A) is an interviewer-administered assessment tool used to evaluate the severity of anxiety symptoms over the past 7 days. It consists of 14 items and includes both psychological and physical anxiety symptoms. Each item is rated on a scale from 0 to 4, with the total score ranging from 0 to 56, where higher scores indicate more severe anxiety.
Time frame
Baseline, immediately after the 8-week intervention, and at 2-month follow-up.4
Change from baseline Anxiety Sensitivity Index (ASI)score
The ASI consists of 16 items, each rated on a scale from 0 (very little) to 4 (very much), where respondents indicate how much they agree with statements about their anxiety-related concerns. The total score ranges from 0 to 64, with higher scores reflecting greater anxiety sensitivity.
Time frame
Baseline, immediately after the 8-week intervention, and at 2-month follow-up.Sponsors and contacts
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Source ClinicalTrials.gov