Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06616116
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-06
Brief Title:
Stress Management with Real-time Bio-signal Biofeedback
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Development and Verification of Effectiveness of Biofeedback Contents for Stress Management Using Real-time Bio-signal Monitoring Device
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None