Stress Management with Real-time Bio-signal Biofeedback

Launched by SEOUL NATIONAL UNIVERSITY HOSPITAL · Sep 24, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring whether a special device called the Neuronicle FX2, which monitors brain activity and heart rate, can help manage stress and improve symptoms of mood disorders like bipolar disorder and major depressive disorder. Participants will engage in mindfulness-based cognitive therapy (MBCT) sessions once a week for eight weeks. Half of the participants will use the Neuronicle FX2 device during these sessions to receive real-time feedback on their body's signals, while the other half will not receive this feedback. The researchers want to see if the device makes a difference in reducing stress and improving feelings of anxiety and depression.

To be eligible for this trial, participants should be between 15 and 59 years old and have a diagnosis of a mood disorder along with symptoms of anxiety and stress. They must be able to understand and communicate in Korean and agree to attend weekly sessions. Throughout the trial, participants will wear the device during mindfulness exercises and will complete questionnaires to track their progress. This study is currently recruiting participants, and it’s important to note that certain individuals, such as those with other major psychiatric disorders or specific medical conditions, may not qualify for participation.

Gender

ALL

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.