Who is eligible for clinical trial NCT06537258?

Participants must meet protocol criteria for Inflammatory Bowel Diseases. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT06537258 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-03-27

Heart Rate Variability and Inflammatory Bowel Disease (NCT06537258)

🟢 Recruiting Observational / Diagnostic 🧠 Behavioral & Psychological Program Sponsor: Emory University

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (5 items).

Location: Atlanta Metropolitan Area — Atlanta, Georgia

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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)

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (3 Sites)

Atlanta Metropolitan Area — Atlanta, Georgia
Children's Healthcare of Atlanta — Atlanta, Georgia
Center for Advanced Pediatrics — Atlanta, Georgia

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗