Heart Rate Variability and Inflammatory Bowel Disease

Emory University128 enrolled

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). 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

128

Conditions

Inflammatory Bowel Diseases

Interventions

Biofeedback Enhanced TreatmentBEHAVIORAL

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, and participants will be asked to rate their subjective level of stress with each trial. At all assessment points (T1-T4), participants will be provided with stool collection kits to collect a stool sample within 3 days of the laboratory psychophysiological assessment. At all assessment points (T1-T4), a blood draw of approximately 3 ml of blood will be collected.

Eligibility

Sex: ALLMin age: 13 YearsMax age: 18 Years

Medical Language ↔ Plain English

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)

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

Outcomes

Primary Outcomes

Changes in psychological distress

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.

Time frame: Baseline, 6 weeks post-intervention

Central Contacts

Bonney Reed, PhD

CONTACT

404-727-8312 ebreed@emory.edu

Data from ClinicalTrials.gov

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