Heart Rate Variability and Inflammatory Bowel Disease
Recruiting now · Not applicable
Conditions studied: Inflammatory Bowel Diseases
In brief
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.
Key facts
- Study ID
- NCT06537258
- Run by
- Emory University
- People needed
- 128
- Starts
- 2025-02-06
- Expected to finish
- 2028-10-01
- Last updated by the study team
- 2026-04-01
Who can join
Age: 13 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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.
Where it is running
- Atlanta Metropolitan Area — Atlanta, Georgia, United States (enrolling)
- Children's Healthcare of Atlanta — Atlanta, Georgia, United States (enrolling)
- Center for Advanced Pediatrics — Atlanta, Georgia, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.