Back to Trials
NCT06537258NARecruiting

Heart Rate Variability and Inflammatory Bowel Disease

Emory University

Start Date

2/6/2025

Completion Date

10/1/2028

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.

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 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

Age Range: 13 years to 18 years

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.

Interventions

BEHAVIORAL

Biofeedback Enhanced Treatment

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Inflammatory Bowel Diseases

Locations

Atlanta Metropolitan Area

Atlanta, Georgia 30303

United States

Children's Healthcare of Atlanta

Atlanta, Georgia 30322

United States

Center for Advanced Pediatrics

Atlanta, Georgia 30329

United States