Coping skills program using heart rate biofeedback for youth with inflammatory bowel disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of a virtually delivered, group-based coping skills treatment program that incorporates heart rate variability biofeedback for youth aged 13-18 diagnosed with inflammatory bowel disease (IBD). Participants will be randomized into either a biofeedback enhanced treatment group or a wait-list control group. The study will involve surveys, chart reviews, blood sampling, and non-invasive assessments over a 7-month period, including four in-person visits and six virtual sessions. The goal is to address autonomic dysfunction associated with IBD through cognitive behavioral therapy techniques.

Why it matters

Who can join: the full rules

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.

Where it's running

• 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

Study contacts

• Principal investigator: Bonney Reed, PhD — Emory University
• Study coordinator: Bonney Reed, PhD
• Email: ebreed@emory.edu
• Phone: 404-727-8312

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.