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NCT Number: NCT06537258

Heart Rate Variability and Inflammatory Bowel Disease

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.

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Key information

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atlanta Metropolitan Area, Atlanta, Georgia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: biofeedback cognitive behaviorally based coping skills treatment

Primary outcomes

  1. Changes in psychological distress

    Time frame: Baseline, 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bonney Reed, PhD

CONTACT

[email protected]

404-727-8312

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

A Heart Rate Variability Biofeedback Enhanced Behavioral Intervention to Improve Psychological and Disease Functioning in Youth With Inflammatory Bowel Disease (IBD)

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Aug 5, 2024
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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