Search / Trial NCT06616116

Stress Management with Real-time Bio-signal Biofeedback

Launched by SEOUL NATIONAL UNIVERSITY HOSPITAL · Sep 24, 2024

Trial Information

Current as of October 08, 2024

Recruiting

Keywords

Biosignal Neurofeedback Mindfulness Bipolar Disorder Major Depressive Disorder

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, par...

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.

About Seoul National University Hospital

Seoul National University Hospital (SNUH) is a leading medical institution in South Korea, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a prominent clinical trial sponsor, SNUH integrates cutting-edge scientific inquiry with patient-centered care, facilitating the development of novel therapies and treatment protocols. The hospital boasts a diverse range of specialized departments and a robust infrastructure for conducting clinical studies, ensuring rigorous adherence to ethical standards and regulatory compliance. By fostering collaboration among multidisciplinary teams, SNUH aims to contribute significantly to global medical advancements and improve patient outcomes.

Locations

Seoul, , Korea, Republic Of

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0