Heart Rate Variability and Inflammatory Bowel Disease

Not Applicable

Recruiting

• Conditions: Inflammatory Bowel Diseases

• Registration Number: NCT06537258
• Lead Sponsor: Emory University

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.

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.

Study Timeline

• Study First Submitted: 2024-08-01
• Study First Submitted QC: 2024-08-01
• Study First Posted: 2024-08-05
• Study Start: 2025-02-06
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-03-14
• Primary Completion: 2028-10
• Study Completion: 2028-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 128

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in psychological distress	Baseline, 6 weeks post-intervention	A continuous composite measure of stress, anxiety, and depression. Which will be analyzed continuously to evaluate for a significant mean difference between randomized groups at study endpoint (6-weeks). Scores range from 0 to 63, with higher scores indicating greater distress.

Trial Locations

Locations (3)

Atlanta Metropolitan Area; 🇺🇸 Atlanta, Georgia, United States

Children's Healthcare of Atlanta; 🇺🇸 Atlanta, Georgia, United States

Center for Advanced Pediatrics; 🇺🇸 Atlanta, Georgia, United States