Clinical trial NCT06616116: Stress Management with Real-time Bio-signal Biofeedback
Official title: Development and Verification of Effectiveness of Biofeedback Contents for Stress Management Using Real-time Bio-signal Monitoring Device
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bipolar Disorder (BD)
Major Depressive Diorder
Keywords: biosignal
neurofeedback
mindfulness
bipolar disorder
major depressive disorder
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2024-09-27
Enrollment: 100
Sex: ALL
Minimum age (years): 15
Maximum age (years): 59
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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:

1. Biosignal-guided group: Participants will receive real-time biofeedback during mindfulness exercises. This feedback, derived from biosignals like brainwave activity (EEG), will help guide their mindfulness practice. In addition, participants in this group will receive a report summarizing their EEG and HRV data before, during, and after each mindfulness session to track their progress and provide insights into their physiological responses.
2. Standard group: Participants will engage in the same mindfulness exercises, but without receiving real-time feedback. Their biosignals will still be monitored for comparative purposes.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).
* 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).
* 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 \&lt; 70, dementia).
* Individuals with medical, psychological, social, or legal issues that would interfere with continued participation in the program.

Primary outcomes:
measure: Changes from baseline Korean Perceived Stress Scale (K-PSS) score at 8wks, and 16 wks
timeFrame: Baseline (pre-treatment), immediately after the 8-week intervention, and at 2-month follow-up.
Secondary outcomes:
measure: Change from baseline Inventory of Depressive Symptomatology (IDS-SR) score
timeFrame: Baseline, immediately after the 8-week intervention, and at 2-month follow-up.
measure: Change from baseline Hamilton depression rating scale (HAM-D) score
timeFrame: Baseline, immediately after the 8-week intervention, and at 2-month follow-up.
measure: Change from baseline Hamilton anxiety rating scale (HAM-A) score
timeFrame: Baseline, immediately after the 8-week intervention, and at 2-month follow-up.
measure: Change from baseline Anxiety Sensitivity Index (ASI)score
timeFrame: Baseline, immediately after the 8-week intervention, and at 2-month follow-up.
measure: Change from baseline Generalized Anxiety Disorder-7 (GAD-7) score
timeFrame: Baseline, immediately after the 8-week intervention, and at 2-month follow-up.
measure: Change from baseline Young Mania Rating Scale (YMRS) score
timeFrame: Baseline, immediately after the 8-week intervention, and at 2-month follow-up.
measure: Change from baseline Beck Scale for Suicide Ideation(SSI-Beck) score
timeFrame: Baseline, immediately after the 8-week intervention, and at 2-month follow-up.
measure: Change from baseline Patient Health Questionnaire-15 (PHQ-15) score
timeFrame: Baseline, immediately after the 8-week intervention, and at 2-month follow-up.
measure: Change from baseline World Health Organization Quality of Life-BREF (WHOQOL-BREF) score
timeFrame: Baseline, immediately after the 8-week intervention, and at 2-month follow-up.
measure: Change from baseline Five-Factor Mindfulness Questionnaire (FFMQ-Short Form) score
timeFrame: Baseline, immediately after the 8-week intervention, and at 2-month follow-up.
measure: Change from baseline Cognitive and Affective Mindfulness Scale-Revised (CAMS-R) score
timeFrame: Baseline, immediately after the 8-week intervention, and at 2-month follow-up.
measure: Heart Rate Variability (HRV)
timeFrame: Baseline, immediately after the 8-week intervention, and at 2-month follow-up.
measure: Quantitative electroencephalography (QEEG)
timeFrame: Baseline, immediately after the 8-week intervention, and at 2-month follow-up.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Jongno-gu
Study officials:
References: