Coping skills program using heart rate biofeedback for youth with inflammatory bowel disease
A Heart Rate Variability Biofeedback Enhanced Behavioral Intervention to Improve Psychological and Disease Functioning in Youth With Inflammatory Bowel Disease (IBD)
This study is testing a new online program that helps teenagers with inflammatory bowel disease learn coping skills and manage their stress by using heart rate biofeedback.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 128 (estimated) |
| Ages | 13 Years to 18 Years |
| Sex | All |
| Sponsor | Emory University Academic / other |
| Locations | 3 sites (Atlanta, Georgia and 2 other locations) |
| Trial ID | NCT06537258 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are youth aged 13-18 with biopsy-confirmed IBD and experiencing symptoms of depression or anxiety.
Not a fit: Patients with developmental disabilities, other chronic diseases, or those on medications affecting autonomic function may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could improve coping strategies and overall well-being for youth suffering from inflammatory bowel disease.
How similar studies have performed: Other studies have shown promise in using biofeedback and cognitive behavioral therapy for managing chronic conditions, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Atlanta, Georgia and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.