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RECRUITING
NCT06537258
NA

Heart Rate Variability and Inflammatory Bowel Disease

Sponsor: Emory University

View on ClinicalTrials.gov

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.

Official title: A Heart Rate Variability Biofeedback Enhanced Behavioral Intervention to Improve Psychological and Disease Functioning in Youth With Inflammatory Bowel Disease (IBD)

Key Details

Gender

All

Age Range

13 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

128

Start Date

2025-02-06

Completion Date

2028-10

Last Updated

2026-04-01

Healthy Volunteers

No

Interventions

BEHAVIORAL

Biofeedback Enhanced Treatment

At all 4 assessment points (T1-T4), HRV will be measured using the ECG module of the mobile MindWare system at a sampling rate of 500 Hz, and a Skin Conductance Response (SCR) will be collected at a sampling rate of 10 Hz using eSense for iPad. Electrodes to assess SCR and HRV will be attached to patients during an \~10-minute period. A 5-minute initial baseline assessment will occur first followed by three 5-minute stress trials. Stress tasks will be audio recorded to measure study fidelity, and participants will be asked to rate their subjective level of stress with each trial. At all assessment points (T1-T4), participants will be provided with stool collection kits to collect a stool sample within 3 days of the laboratory psychophysiological assessment. At all assessment points (T1-T4), a blood draw of approximately 3 ml of blood will be collected.

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