128
Participants
Start Date
February 6, 2025
Primary Completion Date
October 31, 2028
Study Completion Date
October 31, 2028
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."
RECRUITING
Atlanta Metropolitan Area, Atlanta
RECRUITING
Children's Healthcare of Atlanta, Atlanta
RECRUITING
Center for Advanced Pediatrics, Atlanta
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Emory University
OTHER