Heart Rate Variability and Inflammatory Bowel Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biofeedback Enhanced Treatment.
- Who it may be relevant to
- Registry conditions: Inflammatory Bowel Diseases. Basic parameters: 13 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Heart Rate Variability Biofeedback Enhanced Behavioral Intervention to Improve Psychological and Disease Functioning in Youth With Inflammatory Bowel Disease (IBD)
Overview
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.
Detailed description
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).
Patients are youth ages 13-18 recruited through IBD clinics at Children's Healthcare of Atlanta. Enrollment will include up to 128 children with at least 1 parent. This study will last 7-months and will have 4 in person study visits, lasting about 1 hour each, as well as 6 virtual treatment sessions lasting about 45 minutes each.
Study procedures will include surveys, chart/record review, blood sampling, and non-invasive assessments of psychophysiological functioning. Stool samples will be collected and stored. Informed consent and assent will be obtained in-person or remote signed.
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,
Primary outcome measures
- Changes in psychological distress [Time frame: Baseline, 6 weeks post-intervention]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 3 centers
- Atlanta Metropolitan Area — Atlanta
- Children's Healthcare of Atlanta — Atlanta
- Center for Advanced Pediatrics — Atlanta
Identifiers
NCT: NCT06537258 · STUDY00007611 · R01DK139653-01 · 2025P009521