Status:
RECRUITING
Heart Rate Variability and Inflammatory Bowel Disease
Lead Sponsor:
Emory University
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Inflammatory Bowel Diseases
Eligibility:
All Genders
13-18 years
Phase:
NA
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 dysfunc...
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 dysfunc...
Eligibility Criteria
Inclusion
- Diagnosis with biopsy-confirmed IBD for at least 4 months,
- ages 13 through 18 years inclusive,
- speak English,
- enrolling with at least 1 parent/guardian who is willing to participate by completing surveys,
- positive depression or anxiety screens using the PHQ-4, - access to home internet to participate in virtual intervention,
- youth and parent agree to the conditions of study participation, including randomization, participation in intervention, and follow-up assessments,
- youth is medically approved to engage in normal daily activities (e.g., attend school, extracurricular activities)
Exclusion
- previous diagnosis of developmental disabilities that require full-time special education or that impair the ability to respond to treatment,
- diagnosis with any other chronic disease (e.g., diabetes, epilepsy, etc.),
- diagnosis of abnormal thyroid function,
- treatment with any drug with known autonomic cardiovascular influences including beta-blockers, central sympatholytic agents, or antidepressants.
Key Trial Info
Start Date :
February 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2028
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT06537258
Start Date
February 6 2025
End Date
October 1 2028
Last Update
March 14 2025
Active Locations (3)
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1
Atlanta Metropolitan Area
Atlanta, Georgia, United States, 30303
2
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
3
Center for Advanced Pediatrics
Atlanta, Georgia, United States, 30329