Managing stress in mood disorders using biofeedback and mindfulness
Development and Verification of Effectiveness of Biofeedback Contents for Stress Management Using Real-time Bio-signal Monitoring Device
This study is testing if using real-time biofeedback during mindfulness exercises can help people aged 15 to 60 with mood disorders manage stress and feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 15 Years to 59 Years |
| Sex | All |
| Sponsor | Seoul National University Hospital Academic / other |
| Locations | 1 site (Seoul, Jongno-gu) |
| Trial ID | NCT06616116 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of real-time bio-signal monitoring combined with mindfulness-based cognitive therapy (MBCT) for individuals aged 15 to 60 diagnosed with mood disorders like bipolar disorder and major depressive disorder. Participants will be randomly assigned to either a biosignal-guided group, receiving real-time feedback during mindfulness exercises, or a standard group without feedback. The study aims to determine if the biofeedback enhances stress management and improves symptoms of depression and anxiety over an 8-week period. Assessments will be conducted using validated measures to track changes in perceived stress and mood symptoms.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 15 to 59 with mood disorders and accompanying anxiety symptoms.
Not a fit: Patients with major psychiatric disorders other than mood disorders or those experiencing acute psychotic symptoms may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel method for effectively managing stress and improving mood disorder symptoms.
How similar studies have performed: Other studies have shown promise in using biofeedback and mindfulness for mood disorders, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Seoul, Jongno-gu
- Seoul National University Hospital — Seoul, Jongno-gu, South Korea (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.