Heart Rate Variability and Inflammatory Bowel Disease

Emory University

Status: Enrolling

Conditions: Inflammatory Bowel Diseases

Treatments: Behavioral: Biofeedback Enhanced Treatment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06537258

R01DK139653-01 (U.S. NIH Grant/Contract)

STUDY00007611

Details and patient eligibility

About

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.

Full 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.

Enrollment: 128 estimated patients

Sex: All

Ages: 13 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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128 participants in 2 patient groups

Biofeedback Enhanced Treatment

Experimental group

Description:

Participants in this group will participate in biofeedback enhanced cognitive behaviorally based coping skills treatment. Treatment will consist of a 6-visit group intervention conducted online, via Emory zoom. Groups will include 5-8 patients. Groups will meet approximately each week for 6 weeks. Patients will also rate their disease symptoms and measures of clinical disease activity will be collected via chart review. Clinical assessments will occur at baseline within 1 week prior to starting treatment (T1), at treatment end or 6 weeks after baseline (T2), 14 weeks after baseline to capture 2-month follow-up after treatment (T3) and at 26 weeks after baseline (T4).

Treatment:

Behavioral: Biofeedback Enhanced Treatment

Wait-list control

No Intervention group

Description:

Participants randomized to the waitlist control group will complete the same assessment protocol at the time of randomization (Baseline) and again 6 weeks later. They will then be invited to begin treatment and will repeat the assessments at posttest and again at 14 and 26-week follow-up (for a total of 5 assessments).