Heart Rate Variability and Inflammatory Bowel Disease

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Biofeedback Enhanced Treatment
  At all 4 assessment points (T1-T4), HRV will be measured using the ECG module of the mobile MindWare system at a sampling rate of 500 Hz, and a Skin Conductance Response (SCR) will be collected at a sampling rate of 10 Hz using eSense for iPad. Electrodes to assess SCR and HRV will be attached to patients during an \~10-minute period. A 5-minute initial baseline assessment will occur first followed by three 5-minute stress trials. Stress tasks will be audio recorded to measure study fidelity,

Первичные конечные точки

• Changes in psychological distress [Срок оценки: Baseline, 6 weeks post-intervention]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 3 центра

• Atlanta Metropolitan Area — Atlanta
• Children's Healthcare of Atlanta — Atlanta
• Center for Advanced Pediatrics — Atlanta

Идентификаторы

NCT: NCT06537258 · STUDY00007611 · R01DK139653-01 · 2025P009521

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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