Stress Management with Real-time Bio-signal Biofeedback

NCT06616116 | Recruiting

• 1 other identifier: RS-2023-00279070
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder (BD); Major Depressive Diorder

Keywords

biosignal; neurofeedback; mindfulness; bipolar disorder; major depressive disorder

Outcome Measures

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.

  Baseline (pre-treatment), immediately after the 8-week intervention, and at 2-month follow-up.

Secondary Outcomes (13)

• Change from baseline Inventory of Depressive Symptomatology (IDS-SR) score

  Baseline, immediately after the 8-week intervention, and at 2-month follow-up.

• Change from baseline Hamilton depression rating scale (HAM-D) score

  Baseline, immediately after the 8-week intervention, and at 2-month follow-up.

• Change from baseline Hamilton anxiety rating scale (HAM-A) score

  Baseline, immediately after the 8-week intervention, and at 2-month follow-up.

• Change from baseline Anxiety Sensitivity Index (ASI)score

  Baseline, immediately after the 8-week intervention, and at 2-month follow-up.

• Change from baseline Generalized Anxiety Disorder-7 (GAD-7) score

  Baseline, immediately after the 8-week intervention, and at 2-month follow-up.

Study Arms (2)

Mindfulness with biosignal feedback

EXPERIMENTAL

Biosignal Monitoring (EEG and HRV) with Real-time neurofeedback during Mindfulness

Device: Biosignal feedback

Mindfulness without biosignal feedback

SHAM COMPARATOR

Biosignal Monitoring (EEG and HRV) without Real-time neurofeedback during Mindfulness

Device: Sham Comparator

Interventions

Biosignal feedback DEVICE

1. 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.

Also known as: biofeedback, neurofeedback, real-time

Mindfulness with biosignal feedback

Sham Comparator DEVICE

Biosignal Monitoring (EEG and HRV) during Mindfulness without real-time feedback

Also known as: Biosignal monitoring only

Mindfulness without biosignal feedback

Eligibility Criteria

• Age: 15 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 \< 70, dementia).
• Individuals with medical, psychological, social, or legal issues that would interfere with continued participation in the program.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, Jongno-gu, 03080, South Korea

RECRUITING

MeSH Terms

Conditions

Bipolar Disorder; Depressive Disorder, Major

Interventions

Biofeedback, Psychology; Neurofeedback; Real-Time Polymerase Chain Reaction

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Depressive Disorder

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological; Polymerase Chain Reaction; Nucleic Acid Amplification Techniques; Genetic Techniques; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD., PhD, Assistant Professor of Clinical Psychiatry, Department of Psychiatry

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 27, 2024
• Study Start: June 13, 2024
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: September 27, 2024

Record last verified: 2024-09

Locations

KR (1)