Neural Mechanisms of Treatment Response to ADAPT
- Conditions
- Functional Abdominal Pain SyndromeAnxiety
- Registration Number
- NCT03518216
- Lead Sponsor
- Michigan State University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 49
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Primary Outcome Measures
Name Time Method Functional Connectivity of Amygdala with the Prefrontal Cortex through study completion, an average of 9 weeks Changes in functional connectivity will be examined using the Blood Oxygenation Level Dependent (BOLD) effect
- Secondary Outcome Measures
Name Time Method Screen for Child Anxiety Related Disorders through study completion, an average of 9 weeks Patient-reported measure of anxiety symptoms over the past 3 months
State Anxiety through study completion, an average of 9 weeks 0 - 10 self-report of how anxious the child is feeling in the present moment
Pain Intensity/Unpleasantness via Visual Analog Scale through study completion, an average of 9 weeks State pain intensity and unpleasantness levels using a 0 - 10 scale
Regional Brain Activation in Areas Associated with Cognitive, Affective, and Visceral Afferent Aspects of Pain through study completion, an average of 9 weeks Changes in regional brain activity will be assessed by arterial spin labeling (ASL)
Neuroimaging data linked to pain and anxiety outcomes through study completion, an average of 9 weeks Changes in functional connectivity/regional brain activation will correspond with changes in pain and anxiety
Affective Reactivity Index- Self Report through study completion, an average of 9 weeks 7-item measure of emotional regulation
Child Pain History through study completion, an average of 9 weeks Demographic factors, school absences, and pain duration, location, etc via caregiver report
NIH Promis Pain Interference through study completion, an average of 9 weeks Measure of functional impairment due to pediatric pain
Peterson Pubertal Development Scale through study completion, an average of 9 weeks Pubertal status assessed via clinical interview
Medication use through study completion, an average of 9 weeks current medication use will be obtained via medical chart review and parent report
Generalized Anxiety Disorders 7 (GAD-7) through study completion, an average of 9 weeks Patient-reported measure of anxiety symptoms over the past 2 weeks. Measures contains 7 items measured on a scale of 0-21 with higher scores indicating greater anxiety.
Self-Efficacy Pain Scale- Child Version through study completion, an average of 9 weeks Measure of child self-efficacy when in pain
Children's Depression Inventory 2 through study completion, an average of 9 weeks A measure of depressive symptoms in the past 2 weeks
Patient Health Questionnaire 9 through study completion, an average of 9 weeks A 9-item measure of depressive symptoms in the past 2 weeks. Scores range from 0-27 with higher scores indicating greater depressive symptoms.
Depression Anxiety Stress Scales through study completion, an average of 9 weeks Measure of caregiver depression, anxiety, and tension/stress.
Functional Disability Inventory- Parent Report through study completion, an average of 9 weeks Parent-reported child anxiety symptoms over the past three months; ≥25 is clinical anxiety
Child COVID-19 Related Distress through study completion, an average of 9 weeks A visual analog scale item assessing for the child's COVID-related distress on a scale of 0-10. A greater score indicates greater distress.
MRI Safety and Screening at screening to determine eligibility Utilized to determine if patient can safely complete fMRI protocol
Fullness Rating Scale through study completion, an average of 9 weeks Youth will use scale to indicate how full they feel before and after water ingestion
Pain Catastrophizing Scale through study completion, an average of 9 weeks Maladaptive beliefs about pain and long-term outcomes completed by caregiver
Adverse Childhood Events (ACEs) through study completion, an average of 9 weeks A 9-item query for frequency of adverse events experienced during childhood. Frequency count ranges from 0-9 with a higher score indicating a greater number of adverse childhood events.
COVID-19 Exposure and Family Impact Survey (CEFIS) through study completion, an average of 9 weeks 38-item measure of COVID-19 related distress and impact on families and caregivers. Part 1 of the measure queries the frequency of COVID-related events on a scale of 0-25 with higher scores indicating a greater number of experienced events. Part 2 of the measures the adverse impact of COVID-related events and has a score range of 12-60 with higher scores indicating a greater adverse impact.
Edinburgh Handedness Inventory through study completion, an average of 9 weeks To assess the dominance of a person's right or left hand in everyday activities; one item was removed (striking a match) because it is not appropriate for children
Screen for Child Anxiety Related Disorders- Parent Report through study completion, an average of 9 weeks Parent-reported child anxiety symptoms over the past three months; ≥25 is clinical anxiety
Self-Efficacy Chronic Pain Scale- Parent Version through study completion, an average of 9 weeks Parent reported child self-efficacy during pain
Affective Reactivity Index- Parent- Report through study completion, an average of 9 weeks 7-item measure of child emotional regulation
Functional Disability Inventory through study completion, an average of 9 weeks A 15-item self report inventory measuring perceived pain-related disability
Rome IV Diagnosis Checklist at screening to determine eligibility Physician reported FAPD criteria (based on the Rome IV) met by the patient
Pain Catastrophizing Scale for Children through study completion, an average of 9 weeks Maladaptive beliefs about pain and long-term processes
Trial Locations
- Locations (1)
Michigan State University
🇺🇸Grand Rapids, Michigan, United States
Michigan State University🇺🇸Grand Rapids, Michigan, United States