Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06537258
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-01
Brief Title:
Heart Rate Variability and Inflammatory Bowel Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Heart Rate Variability Biofeedback Enhanced Behavioral Intervention to Improve Psychological and Disease Functioning in Youth With Inflammatory Bowel Disease IBD
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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 goals of this study are to test the effectiveness of a virtually delivered group-based coping skills treatment program incorporating heart rate variability biofeedback to target autonomic dysfunction in youth diagnosed with inflammatory bowel disease IBD The investigators will enroll participants with IBD in a biofeedback enhanced cognitive behaviorally based coping skills treatment Participants will be randomized to biofeedback enhanced treatment or wait-list control
Detailed Description:
The goals of this study are to test the effectiveness of a virtually delivered group-based coping skills treatment program incorporating heart rate variability biofeedback to target autonomic dysfunction in youth diagnosed with inflammatory bowel disease IBD
Patients are youth ages 13-18 recruited through IBD clinics at Childrens Healthcare of Atlanta Enrollment will include up to 128 children with at least 1 parent This study will last 7-months and will have 4 in person study visits lasting about 1 hour each as well as 6 virtual treatment sessions lasting about 45 minutes each
Study procedures will include surveys chartrecord review blood sampling and non-invasive assessments of psychophysiological functioning Stool samples will be collected and stored Informed consent and assent will be obtained in-person or remote signed
Patients are youth ages 13-18 recruited through IBD clinics at Childrens Healthcare of Atlanta Enrollment will include up to 128 children with at least 1 parent This study will last 7-months and will have 4 in person study visits lasting about 1 hour each as well as 6 virtual treatment sessions lasting about 45 minutes each
Study procedures will include surveys chartrecord review blood sampling and non-invasive assessments of psychophysiological functioning Stool samples will be collected and stored Informed consent and assent will be obtained in-person or remote signed
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