Actively Recruiting
Heart Rate Variability and Inflammatory Bowel Disease
Led by Emory University · Updated on 2026-04-01
128
Participants Needed
3
Research Sites
190 weeks
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Heart Rate Variability and Inflammatory Bowel Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with biopsy-confirmed inflammatory bowel disease for at least 4 months
- Ages 13 through 18 years inclusive
- Able to speak English
- Enrolling with at least one parent or guardian who will complete surveys
- Positive depression or anxiety screen using the PHQ-4
- Access to home internet for virtual intervention participation
- Youth and parent agree to study conditions including randomization, intervention, and follow-ups
- Youth is medically cleared to engage in normal daily activities like school and extracurriculars
You will not qualify if you...
- Previous diagnosis of developmental disabilities requiring full-time special education or impairing treatment response
- Diagnosis of any other chronic disease such as diabetes or epilepsy
- Diagnosis of abnormal thyroid function
- Currently treated with drugs affecting autonomic cardiovascular function, including beta-blockers, central sympatholytic agents, or antidepressants
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Atlanta Metropolitan Area
Atlanta, Georgia, United States, 30303
Actively Recruiting
2
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Actively Recruiting
3
Center for Advanced Pediatrics
Atlanta, Georgia, United States, 30329
Actively Recruiting
Research Team
B
Bonney Reed, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here