Heart Rate Variability and Inflammatory Bowel Disease Study

This study is looking at a coping skills program called Biofeedback Enhanced Treatment for young people aged 13-18 who have Inflammatory Bowel Disease (IBD). This program uses biofeedback, which helps you learn to control body functions like heart rate, to improve how your body responds to stress. The goal is to see if this virtual, group-based program can help reduce psychological distress in youth with IBD. You can join if you have IBD, are between 13 and 18, speak English, and have a parent or guardian willing to participate. You also need to have access to home internet and screen positive for depression or anxiety. The study aims to enroll up to 128 participants, and its current status is unclear.

Study design: This is an interventional study where participants will be randomly assigned to either receive the Biofeedback Enhanced Treatment or be in a wait-list control group.
What's involved: You would participate in 4 in-person study visits (about 1 hour each) and 6 virtual treatment sessions (about 45 minutes each) over 7 months. Procedures include surveys, chart reviews, blood samples, and non-invasive assessments.
Compensation: Not stated in the trial record.
Follow-up: Changes in psychological distress will be measured at baseline and 6 weeks after the intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Heart Rate Variability and Inflammatory Bowel Disease

Recruiting

NAAges 13–18InterventionalSupportive care

Emory University

~128 participants

Updated 2026-04-01 on ClinicalTrials.gov

What's tested:Biofeedback Enhanced Treatment

At a glance

Recruiting sites

3 of 3 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Changes in psychological distress

Measured over Baseline, 6 weeks post-intervention

Conditions

Inflammatory Bowel Diseases

Where it's being run

3 sites across 1 states

Georgia3

Study leadership

Bonney Reed, PhD · PRINCIPAL_INVESTIGATOR · Emory University

Who to contact

Bonney Reed, PhD

[email protected]

404-727-8312

Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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

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.

What this trial measures

Changes in psychological distressBaseline, 6 weeks post-intervention
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.

Trialytics