A Heart Rate Variability Biofeedback Enhanced Behavioral Intervention to Improve Psychological and Disease Functioning in Youth With Inflammatory Bowel Disease (IBD)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 128
- 试验地点
- 3
- 主要终点
- Changes in psychological distress
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
研究组 & 干预措施
Biofeedback Enhanced Treatment
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).
干预措施: Biofeedback Enhanced Treatment (Behavioral)
Wait-list control
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).
结局指标
主要结局
Changes in psychological distress
时间窗: Baseline, 6 weeks post-intervention
A continuous composite measure of stress, anxiety, and depression. Which will be analyzed continuously to evaluate for a significant mean difference between randomized groups at study endpoint (6-weeks). Scores range from 0 to 63, with higher scores indicating greater distress.
次要结局
未报告次要终点
研究者
Bonney Reed
Associate Professor
Emory University