NCT06537258 Heart Rate Variability and Inflammatory Bowel Disease
| NCT ID | NCT06537258 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Emory University |
| Condition | Inflammatory Bowel Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 128 participants |
| Start Date | 2025-02-06 |
| Primary Completion | 2028-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 128 participants in total. It began in 2025-02-06 with a primary completion date of 2028-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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 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.
Contact & Investigator
Bonney Reed, PhD
PRINCIPAL INVESTIGATOR
Emory University
Frequently Asked Questions
Who can join the NCT06537258 clinical trial?
This trial is open to participants of all sexes, aged 13 Years or older, up to 18 Years, studying Inflammatory Bowel Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06537258 currently recruiting?
Yes, NCT06537258 is actively recruiting participants. Contact the research team at ebreed@emory.edu for enrollment information.
Where is the NCT06537258 trial being conducted?
This trial is being conducted at Atlanta, United States, Atlanta, United States, Atlanta, United States.
Who is sponsoring the NCT06537258 clinical trial?
NCT06537258 is sponsored by Emory University. The principal investigator is Bonney Reed, PhD at Emory University. The trial plans to enroll 128 participants.