Michigan State University
Grand Rapids, Michigan, 49503, United States
NCT Number: NCT03518216
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.
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Notify Me11 year–16 year
All sexes
Interventional
Not applicable
Grand Rapids, Michigan, 49503, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Aim to Decrease Anxiety and Pain Treatment is a remotely delivered tailored treatment integrating mindfulness meditation and cognitive behavioral therapy. It consists of 6 sessions and blends pain and anxiety coping strategies. The first 2 sessions will be interactive with a trained psychological provider and the following 4 sessions will be web-based. Each web-based session will be followed by therapist support. The intervention is delivered through a HIPAA compliant video platform.
Time frame: through study completion, an average of 9 weeks
Changes in functional connectivity will be examined using the Blood Oxygenation Level Dependent (BOLD) effect
Time frame: through study completion, an average of 9 weeks
Changes in regional brain activity will be assessed by arterial spin labeling (ASL)
Time frame: through study completion, an average of 9 weeks
Changes in functional connectivity/regional brain activation will correspond with changes in pain and anxiety
Time frame: through study completion, an average of 9 weeks
State pain intensity and unpleasantness levels using a 0 - 10 scale
Time frame: through study completion, an average of 9 weeks
0 - 10 self-report of how anxious the child is feeling in the present moment
Time frame: through study completion, an average of 9 weeks
Patient-reported measure of anxiety symptoms over the past 3 months
Time frame: 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.
Time frame: through study completion, an average of 9 weeks
A 15-item self report inventory measuring perceived pain-related disability
Time frame: at screening to determine eligibility
Physician reported FAPD criteria (based on the Rome IV) met by the patient
Time frame: at screening to determine eligibility
Utilized to determine if patient can safely complete fMRI protocol
Time frame: through study completion, an average of 9 weeks
Measure of child self-efficacy when in pain
Time frame: through study completion, an average of 9 weeks
7-item measure of emotional regulation
Time frame: through study completion, an average of 9 weeks
Maladaptive beliefs about pain and long-term processes
Time frame: through study completion, an average of 9 weeks
A measure of depressive symptoms in the past 2 weeks
Time frame: 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.
Time frame: through study completion, an average of 9 weeks
Measure of functional impairment due to pediatric pain
Time frame: through study completion, an average of 9 weeks
Pubertal status assessed via clinical interview
Time frame: 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
Time frame: through study completion, an average of 9 weeks
Youth will use scale to indicate how full they feel before and after water ingestion
Time frame: through study completion, an average of 9 weeks
Demographic factors, school absences, and pain duration, location, etc via caregiver report
Time frame: through study completion, an average of 9 weeks
Measure of caregiver depression, anxiety, and tension/stress.
Time frame: through study completion, an average of 9 weeks
Maladaptive beliefs about pain and long-term outcomes completed by caregiver
Time frame: through study completion, an average of 9 weeks
Parent-reported child anxiety symptoms over the past three months; ≥25 is clinical anxiety
Time frame: through study completion, an average of 9 weeks
Parent-reported child anxiety symptoms over the past three months; ≥25 is clinical anxiety
Time frame: through study completion, an average of 9 weeks
Parent reported child self-efficacy during pain
Time frame: through study completion, an average of 9 weeks
current medication use will be obtained via medical chart review and parent report
Time frame: through study completion, an average of 9 weeks
7-item measure of child emotional regulation
Time frame: 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.
Time frame: 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.
Time frame: 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.
Michigan State University
Other
Using fMRI to Understand Response to an Integrative Treatment for Pain and Anxiety in Pediatric Functional Abdominal Pain Disorders (FAPD)
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