Stress Management with Real-time Bio-signal Biofeedback

NCT ID: NCT06616116

Last Updated: 2024-09-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-13
• Study Completion Date: 2025-12-31

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.

Conditions

Bipolar Disorder (BD); Major Depressive Diorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Mindfulness with biosignal feedback

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

Group Type: EXPERIMENTAL

Biosignal feedback

Intervention Type: 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.

Mindfulness without biosignal feedback

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

Group Type: SHAM_COMPARATOR

Sham Comparator

Intervention Type: DEVICE

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

Interventions

Biosignal feedback

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.

Intervention Type: DEVICE

Sham Comparator

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

Intervention Type: DEVICE

Other Intervention Names

biofeedback; neurofeedback; real-time; Biosignal monitoring only

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hyunju Lee

Principal Investigator, MD., PhD, Assistant Professor of Clinical Psychiatry, Department of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Seoul National University Hospital

Seoul, Jongno-gu, South Korea

Site Status: RECRUITING

Countries

South Korea

Facility Contacts

Hyunju Lee

Role: primary

wandy04@naver.com

820220722413

Hyunju Lee

Role: backup

Other Identifiers

RS-2023-00279070

Identifier Type: -

Identifier Source: org_study_id