Heart Rate Variability and Inflammatory Bowel Disease

NCT06537258 | Recruiting

• 3 other identifiers: STUDY00007611R01DK139653-012025P009521
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Inflammatory Bowel Diseases

Keywords

cognitive behavioral therapy; heart rate variability

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 6 weeks post-intervention

Study Arms (2)

Biofeedback Enhanced Treatment

EXPERIMENTAL

Participants in this group will participate in biofeedback enhanced cognitive behaviorally based coping skills treatment. Treatment will consist of a 6-visit group intervention conducted online, via Emory zoom. Groups will include 5-8 patients. Groups will meet approximately each week for 6 weeks. Patients will also rate their disease symptoms and measures of clinical disease activity will be collected via chart review. Clinical assessments will occur at baseline within 1 week prior to starting treatment (T1), at treatment end or 6 weeks after baseline (T2), 14 weeks after baseline to capture 2-month follow-up after treatment (T3) and at 26 weeks after baseline (T4).

Behavioral: Biofeedback Enhanced Treatment

Wait-list control

NO INTERVENTION

Participants randomized to the waitlist control group will complete the same assessment protocol at the time of randomization (Baseline) and again 6 weeks later. They will then be invited to begin treatment and will repeat the assessments at posttest and again at 14 and 26-week follow-up (for a total of 5 assessments).

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 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.

Also known as: biofeedback cognitive behaviorally based coping skills treatment

Biofeedback Enhanced Treatment

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (3)

Atlanta Metropolitan Area

Atlanta, Georgia, 30303, United States

RECRUITING

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

RECRUITING

Center for Advanced Pediatrics

Atlanta, Georgia, 30329, United States

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Bonney Reed, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bonney Reed, PhD

CONTACT

404-727-8312; ebreed@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: August 5, 2024
• Study Start: February 6, 2025
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 3 months and ending 36 months following article publication.
• Access Criteria: Proposals should be directed to ebreed@emory.edu To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website, Vivli.

Locations

US (3)