Heart Rate Variability and Inflammatory Bowel Disease

NARecruitingINTERVENTIONAL
Enrollment

128

Participants

Timeline

Start Date

February 6, 2025

Primary Completion Date

October 31, 2028

Study Completion Date

October 31, 2028

Conditions
Inflammatory Bowel Diseases
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."

Trial Locations (3)

30303

RECRUITING

Atlanta Metropolitan Area, Atlanta

30322

RECRUITING

Children's Healthcare of Atlanta, Atlanta

30329

RECRUITING

Center for Advanced Pediatrics, Atlanta

All Listed Sponsors
collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

lead

Emory University

OTHER