CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 53 enrolled
Drug / intervention
Biofeedback Enhanced Treatmentbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05202418
NCT05202418N/ACompleted

Physiological Reactivity and Psychosocial Functioning in Pediatric Patients With Gastrointestinal Disease

Emory University·interventional·Posted Jan 21, 2022·Updated Apr 22, 2025

In Brief

A clinical study evaluating Biofeedback Enhanced Treatment for Inflammatory Bowel Diseases and Psychological. Completed, enrolled 53 participants across 3 sites.

Detailed Summary

This is a prospective, assessment-based study to examine the relationship between psychophysiological functioning and psychological symptoms in youth newly diagnosed with inflammatory bowel disease (IBD) compared to healthy controls.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20222023202420252026
First PostedJan 21, 2022
Enrollment StartFeb 27, 2022
Primary CompletionJan 13, 2024
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 4.4 years ago

Interventions

Biofeedback Enhanced Treatmentbehavioral

The intervention involves biofeedback enhanced cognitive behaviorally based coping skills treatment. Treatment will consist of a 6-visit group intervention conducted online, via Emory zoom. Groups will include 5-8 patients each. Sessions will include brief, daily homework to facilitate mastery that is developmentally tailored to youth (e.g., practice skills with support from phone or tablet apps). Groups will meet approximately every week for 6 weeks. Advanced Ph.D. students in clinical psychology and Principal Investigator will deliver the treatment protocol. Participants will complete questionnaires before and after each session to measure autonomic reactivity, lifetime stress, depression, anxiety in response to stress induction, and coping strategies.