Clinical trial NCT06537258: Heart Rate Variability and Inflammatory Bowel Disease
Official title: A Heart Rate Variability Biofeedback Enhanced Behavioral Intervention to Improve Psychological and Disease Functioning in Youth With Inflammatory Bowel Disease (IBD)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Inflammatory Bowel Diseases
Keywords: cognitive behavioral therapy
heart rate variability
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2024-08-05
Enrollment: 128
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Changes in psychological distress
timeFrame: Baseline, 6 weeks post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Atlanta Metropolitan Area
state: Georgia
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
city: Atlanta
country: United States
facility: Center for Advanced Pediatrics
state: Georgia
Study officials:
affiliation: Emory University
name: Bonney Reed, PhD
role: PRINCIPAL_INVESTIGATOR
References: