Heart Rate Variability and Inflammatory Bowel Disease
Not applicable · Testing Biofeedback Enhanced Treatment · 3 sites · Emory University
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Biofeedback Enhanced Treatment (a behavioral program) as supportive care (to help with symptoms or quality of life). Condition(s) listed: Inflammatory Bowel Diseases.
Participants are assigned to groups by chance (randomized).
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 13 to 18
- Any sex
Some of the main requirements, copied from the record:
- Diagnosis with biopsy-confirmed IBD for at least 4 months,
- ages 13 through 18 years inclusive,
- speak English,
Plus 4 more requirement(s). There are also 4 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 128 participants are expected to take part.
- Start date: 2025-02-06.
- Main results expected around 2028-10 (estimate from the record).
- 3 study sites listed (3 marked recruiting) in United States.
Main thing being measured
- Changes in psychological distress (Baseline, 6 weeks post-intervention)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Inflammatory Bowel Diseases |
| Lead sponsor | Emory University |
| Collaborators | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| Enrollment | 128 (estimated) |
| Start date | 2025-02-06 |
| Primary completion (est.) | 2028-10 |
| First posted | 2024-08-05 |
| Last updated | 2026-04-01 |
| Official title | A Heart Rate Variability Biofeedback Enhanced Behavioral Intervention to Improve Psychological and Disease Functioning in Youth With Inflammatory Bowel Disease (IBD) |
| ClinicalTrials.gov ID | NCT06537258 |
Interventions
- Biofeedback Enhanced Treatment (Behavioral)
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 followe…
Full eligibility criteria (from the record)
Inclusion Criteria: * Diagnosis with biopsy-confirmed IBD for at least 4 months, * ages 13 through 18 years inclusive, * speak English, * enrolling with at least 1 parent/guardian who is willing to participate by completing surveys, * positive depression or anxiety screens using the PHQ-4, - access to home internet to participate in virtual intervention, * youth and parent agree to the conditions of study participation, including randomization, participation in intervention, and follow-up assessments, * youth is medically approved to engage in normal daily activities (e.g., attend school, extracurricular activities) Exclusion Criteria: * previous diagnosis of developmental disabilities that require full-time special education or that impair the ability to respond to treatment, * diagnosis with any other chronic disease (e.g., diabetes, epilepsy, etc.), * diagnosis of abnormal thyroid function, * treatment with any drug with known autonomic cardiovascular influences including beta-blockers, central sympatholytic agents, or antidepressants.
Locations (3)
| Site | City | Country | Site status |
|---|---|---|---|
| Atlanta Metropolitan Area | Atlanta, Georgia | United States | Recruiting |
| Children's Healthcare of Atlanta | Atlanta, Georgia | United States | Recruiting |
| Center for Advanced Pediatrics | Atlanta, Georgia | United States | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.