MedTrace Logo

Heart Rate Variability and Inflammatory Bowel Disease

NCT06537258 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2026-04-01

No results posted yet for this study

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.

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.

Sponsors & Collaborators

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

    collaborator NIH

  • Emory University

    lead OTHER

Principal Investigators

  • Bonney Reed, PhD · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-06
Primary Completion
2028-10-31
Completion
2028-10-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06537258 on ClinicalTrials.gov