Using fMRI to Understand Response to an Integrative Treatment for Pain and Anxiety in Pediatric Functional Abdominal Pain Disorders (FAPD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Functional Connectivity of Amygdala with the Prefrontal Cortex
研究概览
简要总结
Complex functional abdominal pain disorders (FAPD) with co-occurring anxiety are highly prevalent in children, can be very disabling, and are not responsive to currently available treatments. This research aims to better understand the neural mechanisms involved in a promising nonpharmacological treatment for FAPD to ultimately guide the development of more targeted treatment approaches for afflicted youth.
详细描述
Functional abdominal pain disorders (FAPD) are among the most common chronic pain conditions of childhood and are associated with significant functional disability, pain, and comorbid anxiety that adversely impacts treatment outcomes. Thus, the PI developed a psychological intervention, Aim to Decrease Anxiety and Pain Treatment (ADAPT; F32HD078049), that targets both pain and anxiety using cognitive behavioral therapy and mindfulness meditation approaches to improve patient outcomes. Preliminary testing has shown that ADAPT reduces pain and anxiety in youth with FAPD. In this study, brain mechanisms implicated in the modulation of pain and response to ADAPT will be investigated. Participants with FAPD and comorbid anxiety will be randomized to either ADAPT or a waitlist control (each condition will last for approximately 6 weeks). Participants will undergo fMRIs to explore changes in functional connectivity and regional brain activation during visceral pain induction (via the water load symptom provocation task; WL-SPT). In Aim 1, functional connectivity patterns associated with a subjective response to pain induction in youth with FAPD who receive ADAPT will be compared to the waitlist control. Conventional blood oxygenation level dependent (BOLD) fMRI will be used to assess functional connectivity to capture moment-to-moment fluctuations in activity. In Aim 2, changes in regional brain activation for those receiving ADAPT will be compared to those in the waitlist condition. The novel arterial spin label (ASL) MRI technique will be used to gain inferences into regional brain activity. In line with the NCCIH funding priorities, this study seeks to increase understanding of the mechanisms through which mind and body approaches impact clinical outcomes in chronic pain and anxiety. Results will advance the field by providing crucial information needed for the refinement and testing of a tailored mind body intervention for FAPD and comorbid anxiety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 11 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Functional Connectivity of Amygdala with the Prefrontal Cortex
时间窗: through study completion, an average of 9 weeks
Changes in functional connectivity will be examined using the Blood Oxygenation Level Dependent (BOLD) effect
次要结局
- Screen for Child Anxiety Related Disorders(through study completion, an average of 9 weeks)
- State Anxiety(through study completion, an average of 9 weeks)
- Pain Intensity/Unpleasantness via Visual Analog Scale(through study completion, an average of 9 weeks)
- Child Pain History(through study completion, an average of 9 weeks)
- Regional Brain Activation in Areas Associated with Cognitive, Affective, and Visceral Afferent Aspects of Pain(through study completion, an average of 9 weeks)
- Neuroimaging data linked to pain and anxiety outcomes(through study completion, an average of 9 weeks)
- Affective Reactivity Index- Self Report(through study completion, an average of 9 weeks)
- Functional Disability Inventory(through study completion, an average of 9 weeks)
- Rome IV Diagnosis Checklist(at screening to determine eligibility)
- Pain Catastrophizing Scale for Children(through study completion, an average of 9 weeks)
- NIH Promis Pain Interference(through study completion, an average of 9 weeks)
- Peterson Pubertal Development Scale(through study completion, an average of 9 weeks)
- Medication use(through study completion, an average of 9 weeks)
- Generalized Anxiety Disorders 7 (GAD-7)(through study completion, an average of 9 weeks)
- Self-Efficacy Pain Scale- Child Version(through study completion, an average of 9 weeks)
- Children's Depression Inventory 2(through study completion, an average of 9 weeks)
- Patient Health Questionnaire 9(through study completion, an average of 9 weeks)
- Depression Anxiety Stress Scales(through study completion, an average of 9 weeks)
- Functional Disability Inventory- Parent Report(through study completion, an average of 9 weeks)
- Child COVID-19 Related Distress(through study completion, an average of 9 weeks)
- MRI Safety and Screening(at screening to determine eligibility)
- Fullness Rating Scale(through study completion, an average of 9 weeks)
- Pain Catastrophizing Scale(through study completion, an average of 9 weeks)
- Adverse Childhood Events (ACEs)(through study completion, an average of 9 weeks)
- COVID-19 Exposure and Family Impact Survey (CEFIS)(through study completion, an average of 9 weeks)
- Edinburgh Handedness Inventory(through study completion, an average of 9 weeks)
- Screen for Child Anxiety Related Disorders- Parent Report(through study completion, an average of 9 weeks)
- Self-Efficacy Chronic Pain Scale- Parent Version(through study completion, an average of 9 weeks)
- Affective Reactivity Index- Parent- Report(through study completion, an average of 9 weeks)
研究者
Natoshia Cunningham
Assistant Professor
Michigan State University