BridgeMD
New treatment option for Bipolar Disorder (BD)
Official title Stress Management with Real-time Bio-signal Biofeedback
ClinicalTrials.gov ID: NCT06616116
What this study is testing
- What it's testing
- 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?
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 15 to 59
You may be able to join 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...
- Patients with accompanying anxiety symptoms.
- Patients with stress symptoms (Perceived Stress Scale score ≥ 10)
- Individuals able to independently complete questionnaires and communicate in Korean.
You likely can't join if
- Patients diagnosed with major psychiatric disorders other than mood disorders (e.g., schizophrenia, substance use disorders including alcohol...
- 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...
- 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).
See the full eligibility 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, Jongno-gu, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 15 years to 59 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, Jongno-gu, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.