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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:
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:
This clinical trial aims to evaluate the effectiveness of biosignal guided Mindfulness-based Cognitive Therapy (MBCT) in managing stress and improving mood disorder symptoms in participants aged 15 to 60, who are diagnosed with mood disorders such as major depressive disorder and bipolar disorder.
Participants will be randomly assigned to one of two groups:
The primary goal of this study is to determine whether real-time biosignal feedback can enhance the effectiveness of mindfulness in reducing perceived stress. Secondary outcomes include changes in depressive and anxiety symptoms. These will be assessed using validated measures like the Korean Perceived Stress Scale (K-PSS), Hamilton Depression Rating Scale (HAM-D), and others.
The trial will run for 8 weeks, with weekly mindfulness sessions. Follow-up assessments will be conducted at 8 and 16 weeks post-intervention to evaluate the long-term effects of the therapy.
This research seeks to contribute to the development of personalized stress management interventions by using biosignal-guided mindfulness as a tool to improve treatment adherence and effectiveness in managing mood disorders.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness with biosignal feedback | Experimental | Biosignal Monitoring (EEG and HRV) with Real-time neurofeedback during Mindfulness |
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| Mindfulness without biosignal feedback | Sham Comparator | Biosignal Monitoring (EEG and HRV) without Real-time neurofeedback during Mindfulness |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biosignal feedback | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (pre-treatment), immediately after the 8-week intervention, and at 2-month follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | Jongno-gu | 03080 | South Korea |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D003866 | Depressive Disorder |
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| ID | Term |
|---|---|
| D001676 | Biofeedback, Psychology |
| D058765 | Neurofeedback |
| D060888 | Real-Time Polymerase Chain Reaction |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D001521 | Behavior Therapy |
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| Sham Comparator | Device | Biosignal Monitoring (EEG and HRV) during Mindfulness without real-time feedback |
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| Baseline, immediately after the 8-week intervention, and at 2-month follow-up. |
| 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. | Baseline, immediately after the 8-week intervention, and at 2-month follow-up. |
| 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. | Baseline, immediately after the 8-week intervention, and at 2-month follow-up. |
| 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. | Baseline, immediately after the 8-week intervention, and at 2-month follow-up. |
| Change from baseline Generalized Anxiety Disorder-7 (GAD-7) score | The Generalized Anxiety Disorder-7 (GAD-7) is a widely used self-report questionnaire designed to assess the severity of generalized anxiety disorder (GAD) symptoms. It is brief, consisting of 7 items that focus on key symptoms of anxiety experienced over the past two weeks. Each item in the GAD-7 is scored on a 4-point scale, based on how often the respondent has experienced symptoms. The total score is the sum of the seven items, giving a range from 0 to 21, with higher scores indicating more severe anxiety. | Baseline, immediately after the 8-week intervention, and at 2-month follow-up. |
| Change from baseline Young Mania Rating Scale (YMRS) score | The Young Mania Rating Scale (YMRS) is a clinician-administered tool used to assess the severity of manic symptoms in individuals with bipolar disorder. It is one of the most widely used rating scales for mania and is particularly useful in both clinical and research settings to evaluate treatment effects or monitor symptom changes over time. The YMRS consists of 11 items, each focusing on different aspects of mania, such as mood, behavior, and cognitive functioning. These items are rated by the clinician based on the individual's behavior and self-report of symptoms over the past 48 hours. The scoring is based on a 0 to 4 scale for most items, but four items (irritability, speech, thought content, and disruptive/aggressive behavior) are scored on a 0 to 8 scale, to give more weight to these important aspects of mania. | Baseline, immediately after the 8-week intervention, and at 2-month follow-up. |
| Change from baseline Beck Scale for Suicide Ideation(SSI-Beck) score | The Scale for Suicide Ideation (SSI), often referred to as the Beck Scale for Suicide Ideation (SSI-Beck), is a clinical tool used to assess the intensity, frequency, and characteristics of suicidal thoughts in individuals. Developed by Aaron T. Beck and colleagues, it is designed to measure the severity of both active and passive suicidal ideation. The SSI-Beck consists of 19 items, each assessing different aspects of suicidal ideation. Each item is rated on a 3-point scale (from 0 to 2), with higher scores indicating greater severity of suicidal thoughts or intent. The total score ranges from 0 to 38, with higher scores suggesting a higher risk of suicide. | Baseline, immediately after the 8-week intervention, and at 2-month follow-up. |
| Change from baseline Patient Health Questionnaire-15 (PHQ-15) score | The Patient Health Questionnaire-15 (PHQ-15) is a self-report questionnaire designed to assess the severity of somatic symptoms, particularly in patients who may have somatization disorders or other medically unexplained physical symptoms. It is part of the broader PHQ suite of tools used for assessing various aspects of mental health. The PHQ-15 consists of 15 items, each related to common physical symptoms that can be associated with psychological distress. Patients rate how much they have been bothered by these symptoms over the past four weeks on a 3-point scale. The total score is calculated by summing the responses, with a range from 0 to 30. Higher scores indicate a greater severity of somatic symptoms. | Baseline, immediately after the 8-week intervention, and at 2-month follow-up. |
| Change from baseline World Health Organization Quality of Life-BREF (WHOQOL-BREF) score | The World Health Organization Quality of Life-BREF (WHOQOL-BREF) is a self-report questionnaire designed to assess an individual's quality of life across various domains. It is a shorter version of the original WHOQOL-100 and is used in both clinical settings and research to evaluate general well-being and life satisfaction in relation to health. The WHOQOL-BREF contains 26 items, which measure quality of life in four main domains: Physical health (7 items), Psychological Health (6 items), Social relationships (3 items), and Environment (8 items). Each item is rated on a 5-point Likert scale, where respondents rate how much they agree with statements or how satisfied they are with certain aspects of their life. Scores are then transformed to reflect a scale of 0 to 100, with higher scores indicating better quality of life. | Baseline, immediately after the 8-week intervention, and at 2-month follow-up. |
| Change from baseline Five-Factor Mindfulness Questionnaire (FFMQ-Short Form) score | The Five-Factor Mindfulness Questionnaire-Short Form (FFMQ-SF) is a condensed version of the original FFMQ, designed to assess the extent to which individuals engage in mindful behavior. The full FFMQ was based on five key aspects of mindfulness derived from multiple sources of mindfulness measurement, and the short form provides a more concise tool for measuring mindfulness in research and clinical settings. The FFMQ-SF consists of 24 items, divided into five subscales representing different facets of mindfulness. Each item is rated on a 5-point Likert scale. The total score and subscale scores are calculated by summing the individual items. Higher scores indicate a higher level of mindfulness. | Baseline, immediately after the 8-week intervention, and at 2-month follow-up. |
| Change from baseline Cognitive and Affective Mindfulness Scale-Revised (CAMS-R) score | The Cognitive and Affective Mindfulness Scale-Revised (CAMS-R) is a self-report questionnaire that assesses mindfulness, focusing on the individual's ability to regulate attention and maintain awareness of the present moment. The Korean version, K-CAMS-R, is an adaptation of the original CAMS-R to ensure cultural relevance and language consistency for Korean-speaking populations. The K-CAMS-R consists of 10 items that measure key aspects of mindfulness. Each item is rated on a 4-point Likert scale, indicating the degree to which the statement applies to the respondent. The total score is the sum of the item scores, with higher scores reflecting greater mindfulness. | Baseline, immediately after the 8-week intervention, and at 2-month follow-up. |
| Heart Rate Variability (HRV) | HRV is recorded with a device (neuroNicle FX2, Laxtha) which include EEG and HRV recording system. HRV is calculated from pulse rate signal recorded at earlobe. | Baseline, immediately after the 8-week intervention, and at 2-month follow-up. |
| Quantitative electroencephalography (QEEG) | EEG is recorded with a device (neuroNicle FX2, Laxtha) which include EEG and HRV recording system. EEG signal is acquired at the prefrontal area, two channels (FP1, FP2) on forehead. Power spectrum analysis of the EEG data will be performed using Fourier analysis. And absolute power, relative power, of each frequency band, symmetry are included. | Baseline, immediately after the 8-week intervention, and at 2-month follow-up. |
| D011613 |
| Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D030141 | Feedback, Psychological |
| D016133 | Polymerase Chain Reaction |
| D021141 | Nucleic Acid Amplification Techniques |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |