RECRUITING

Heart Rate Variability and Inflammatory Bowel Disease

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Inflammatory Bowel Diseasescognitive behavioral therapyheart rate variability

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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). 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.

Official Title

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

Quick Facts

Study Start:2025-02-06
Study Completion:2028-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06537258

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:13 Years to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis with biopsy-confirmed IBD for at least 4 months,
  2. * ages 13 through 18 years inclusive,
  3. * speak English,
  4. * enrolling with at least 1 parent/guardian who is willing to participate by completing surveys,
  5. * positive depression or anxiety screens using the PHQ-4, - access to home internet to participate in virtual intervention,
  6. * youth and parent agree to the conditions of study participation, including randomization, participation in intervention, and follow-up assessments,
  7. * youth is medically approved to engage in normal daily activities (e.g., attend school, extracurricular activities)
  1. * previous diagnosis of developmental disabilities that require full-time special education or that impair the ability to respond to treatment,
  2. * diagnosis with any other chronic disease (e.g., diabetes, epilepsy, etc.),
  3. * diagnosis of abnormal thyroid function,
  4. * treatment with any drug with known autonomic cardiovascular influences including beta-blockers, central sympatholytic agents, or antidepressants.

Contacts and Locations

Study Contact

Bonney Reed, PhD
CONTACT
404-727-8312
ebreed@emory.edu

Principal Investigator

Bonney Reed, PhD
PRINCIPAL_INVESTIGATOR
Emory University

Study Locations (Sites)

Atlanta Metropolitan Area
Atlanta, Georgia, 30303
United States
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
United States
Center for Advanced Pediatrics
Atlanta, Georgia, 30329
United States

Collaborators and Investigators

Sponsor: Emory University

  • Bonney Reed, PhD, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-06
Study Completion Date2028-10

Study Record Updates

Study Start Date2025-02-06
Study Completion Date2028-10

Terms related to this study

Keywords Provided by Researchers

  • cognitive behavioral therapy
  • heart rate variability

Additional Relevant MeSH Terms

  • Inflammatory Bowel Diseases