Heart Rate Variability and Inflammatory Bowel Disease

Last updated: March 13, 2025
Sponsor: Emory University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gastrointestinal Diseases And Disorders

Treatment

Biofeedback Enhanced Treatment

Clinical Study ID

NCT06537258
STUDY00007611
R01DK139653-01
  • Ages 13-18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 bycompleting surveys,

  • positive depression or anxiety screens using the PHQ-4, - access to home internet toparticipate in virtual intervention,

  • youth and parent agree to the conditions of study participation, includingrandomization, participation in intervention, and follow-up assessments,

  • youth is medically approved to engage in normal daily activities (e.g., attendschool, extracurricular activities)

Exclusion

Exclusion Criteria:

  • previous diagnosis of developmental disabilities that require full-time specialeducation 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 includingbeta-blockers, central sympatholytic agents, or antidepressants.

Study Design

Total Participants: 128
Treatment Group(s): 1
Primary Treatment: Biofeedback Enhanced Treatment
Phase:
Study Start date:
February 06, 2025
Estimated Completion Date:
October 31, 2028

Study 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.

Connect with a study center

  • Atlanta Metropolitan Area

    Atlanta, Georgia 30303
    United States

    Active - Recruiting

  • Center for Advanced Pediatrics

    Atlanta, Georgia 30329
    United States

    Active - Recruiting

  • Children's Healthcare of Atlanta

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

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