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Heart Rate Variability and Inflammatory Bowel Disease
NCT06537258 · Emory University
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
A Heart Rate Variability Biofeedback Enhanced Behavioral Intervention to Improve Psychological and Disease Functioning in Youth With Inflammatory Bowel Disease (IBD)
About this study
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).
Patients are youth ages 13-18 recruited through IBD clinics at Children's Healthcare of Atlanta. Enrollment will include up to 128 children with at least 1 parent. This study will last 7-months and will have 4 in person study visits, lasting about 1 hour each, as well as 6 virtual treatment sessions lasting about 45 minutes each.
Study procedures will include surveys, chart/record review, blood sampling, and non-invasive assessments of psychophysiological functioning. Stool samples will be collected and stored. Informed consent and assent will be obtained in-person or remote signed.
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.
Study design
Enrollment target: 128 participants
Allocation: randomized
Masking: none
Age groups: child, adult
Timeline
Starts: 2025-02-06
Estimated completion: 2028-10
Last updated: 2026-04-01
Interventions
Behavioral: Biofeedback Enhanced Treatment
Primary outcomes
- • Changes in psychological distress (Baseline, 6 weeks post-intervention)
Sponsor
Emory University · other
With: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Contacts & investigators
ContactBonney Reed, PhD · contact · ebreed@emory.edu · 404-727-8312
InvestigatorBonney Reed, PhD · principal_investigator, Emory University
All locations (3)
Atlanta Metropolitan AreaRecruiting
Atlanta, Georgia, United States
Children's Healthcare of AtlantaRecruiting
Atlanta, Georgia, United States
Center for Advanced PediatricsRecruiting
Atlanta, Georgia, United States