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NCT06537258 · ClinicalTrials.gov registry record · NA
Heart Rate Variability and Inflammatory Bowel Disease
A NA study of Inflammatory Bowel Diseases, sponsored by Emory University.
- Recruiting
- Registry status
- NA
- Development phase
- 128
- Enrollment target
- 3
- Study locations
NCT06537258: Recruiting NA study of Inflammatory Bowel Diseases, sponsored by Emory University.
NCT06537258 is a NA study of Inflammatory Bowel Diseases that is actively recruiting participants, run by Emory University. The registered enrollment target is 128 participants, below the 42,259-participant average among 48 other Inflammatory Bowel Diseases trials with a reported enrollment target (100% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06537258, a NA study of Inflammatory Bowel Diseases, is actively recruiting participants, sponsored by Emory University.
- RECRUITING
- Registry status
- NA
- Development phase
- 128 participants
- Enrollment target
- 3
- Study locations
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.
Primary Outcome
A continuous composite measure of stress, anxiety, and depression. Which will be analyzed continuously to evaluate for a significant mean difference between randomized groups at study endpoint (6-weeks). Scores range from 0 to 63, with higher scores indicating greater distress.
Conditions Studied
Interventions
- BEHAVIORAL Biofeedback Enhanced Treatment
Study Locations (3)
Georgia
- Atlanta Metropolitan Area - Atlanta
- Children's Healthcare of Atlanta - Atlanta
- Center for Advanced Pediatrics - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 128 participants |
| Start Date | 2025-02-06 |
| Est. Completion | 2028-10 |
| Phase | NA |
What NCT06537258 shows while recruiting
NCT06537258 is an interventional study that assigns participants to a tested intervention. The registered 128 participants enrollment target is mid-sized for trials with a published cap, below the 42,259-participant average among 48 other Inflammatory Bowel Diseases trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Inflammatory Bowel Diseases appearing as the primary indexed condition, and to 1 intervention - of which Biofeedback Enhanced Treatment is the first listed.
NCT06537258 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT06537258 about?
NCT06537258 is a clinical study titled "Heart Rate Variability and Inflammatory Bowel Disease". 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 partici...
What is the current status of trial NCT06537258?
This trial is currently recruiting. It is a NA study. The enrollment target is 128 participants. The study started on 2025-02-06. Estimated completion is 2028-10.
What conditions does trial NCT06537258 study?
This clinical trial studies the following conditions: Inflammatory Bowel Diseases.
What interventions are being tested in trial NCT06537258?
The interventions under investigation include: Biofeedback Enhanced Treatment (BEHAVIORAL).
Who is sponsoring clinical trial NCT06537258?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06537258 being conducted?
This trial has 3 study locations across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Inflammatory Bowel Diseases
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06537258's enrollment target sits among peer trials
128 18th of 48 higher than 31 of 48 other Inflammatory Bowel Diseases trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Inflammatory Bowel Diseases trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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