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
- 1
- 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
- •Children (boys and girls) between 11 and 16 years of age and their parent/primary caregiver.
- •Meets criteria for FAPD based on physician diagnosis of FAPD and ROME IV FAPD criteria
- •Meets criteria for presence of clinically significant anxiety (based on the Generalized Anxiety Disorders-7 [GAD-7] cut-off score ≥10).
- •Sufficient English language ability necessary to complete study measures and protocol.
排除标准
- •Children with significant medical condition(s) with an identifiable organic cause including those that may include abdominal pain symptoms (e.g., Inflammatory Bowel Diseases).
- •Children with a documented developmental delays, autism spectrum disorder, a previously diagnosed thought disorder (i.e., psychosis), or bipolar disorder.
- •Significant visual, hearing, or speech impairment.
- •Organic brain injury.
- •Participants who are currently in psychological therapy for pain or anxiety.
- •Participants with severe depressive symptoms (cut-score ≥20) on the Patient Health Questionnaire 9 [PHQ-9] or active suicidal ideation.
- •Exclusionary criteria specific to the fMRI component of the study:
- •Participants with an implant such as a cochlear implant device, a pacemaker or neurostimulator containing electrical circuitry or generating magnetic signals. Participants with any significant ferrous material in their body that could pose the potential for harm in the fMRI environment or cause signal suppression of key regions (i.e. orthodontia).
- •Female participants who report current/suspected pregnancy.
- •Participants with evidence of claustrophobia.
研究组 & 干预措施
ADAPT
Participants randomized to ADAPT will complete Aim to Decrease Anxiety and Pain Treatment (ADAPT), a remotely delivered tailored intervention that integrates mindfulness meditation with cognitive behavioral therapy. It consists of 6 sessions and blends pain and anxiety coping strategies. The first 2 sessions are interactive with a trained psychological provider and the following 4 sessions are web-based. Each web-based session is followed by therapist support.
干预措施: ADAPT (Behavioral)
Waitlist Control
Participants randomized to waitlist control will receive medical treatment as usual. These participants will be given the opportunity to complete ADAPT upon completion of the post assessment.
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)
- 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)
- Child Pain History(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