An interventional study of ADAPT in Functional Abdominal Pain Syndrome and Anxiety, sponsored by Michigan State University. Completed at 1 site in United States. Open to participants aged 11 Years to 16 Years. Per ClinicalTrials.gov, last updated 2025-10-30.
Sponsored by Michigan State University · Not applicable, Interventional, and Treatment
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.
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.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's enrollment of 49 is below the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
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Exclusion Criteria
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.
Behavioral: ADAPT
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.
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.
Functional Connectivity of Amygdala with the Prefrontal Cortex
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
Regional Brain Activation in Areas Associated with Cognitive, Affective, and Visceral Afferent Aspects of Pain
Changes in regional brain activity will be assessed by arterial spin labeling (ASL)
Time frame: through study completion, an average of 9 weeks
Neuroimaging data linked to pain and anxiety outcomes
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
Pain Intensity/Unpleasantness via Visual Analog Scale
State pain intensity and unpleasantness levels using a 0 - 10 scale
Time frame: through study completion, an average of 9 weeks
State Anxiety
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
Screen for Child Anxiety Related Disorders
Patient-reported measure of anxiety symptoms over the past 3 months
Time frame: through study completion, an average of 9 weeks
Generalized Anxiety Disorders 7 (GAD-7)
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
Functional Disability Inventory
A 15-item self report inventory measuring perceived pain-related disability
Time frame: through study completion, an average of 9 weeks
Rome IV Diagnosis Checklist
Physician reported FAPD criteria (based on the Rome IV) met by the patient
Time frame: at screening to determine eligibility
MRI Safety and Screening
Utilized to determine if patient can safely complete fMRI protocol
Time frame: at screening to determine eligibility
Self-Efficacy Pain Scale- Child Version
Measure of child self-efficacy when in pain
Time frame: through study completion, an average of 9 weeks
Affective Reactivity Index- Self Report
7-item measure of emotional regulation
Time frame: through study completion, an average of 9 weeks
Pain Catastrophizing Scale for Children
Maladaptive beliefs about pain and long-term processes
Time frame: through study completion, an average of 9 weeks
Children's Depression Inventory 2
A measure of depressive symptoms in the past 2 weeks
Time frame: through study completion, an average of 9 weeks
Patient Health Questionnaire 9
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
NIH Promis Pain Interference
Measure of functional impairment due to pediatric pain
Time frame: through study completion, an average of 9 weeks
Peterson Pubertal Development Scale
Pubertal status assessed via clinical interview
Time frame: through study completion, an average of 9 weeks
Edinburgh Handedness Inventory
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
Fullness Rating Scale
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
Child Pain History
Demographic factors, school absences, and pain duration, location, etc via caregiver report
Time frame: through study completion, an average of 9 weeks
Depression Anxiety Stress Scales
Measure of caregiver depression, anxiety, and tension/stress.
Time frame: through study completion, an average of 9 weeks
Pain Catastrophizing Scale
Maladaptive beliefs about pain and long-term outcomes completed by caregiver
Time frame: through study completion, an average of 9 weeks
Screen for Child Anxiety Related Disorders- Parent Report
Parent-reported child anxiety symptoms over the past three months; ≥25 is clinical anxiety
Time frame: through study completion, an average of 9 weeks
Functional Disability Inventory- Parent Report
Parent-reported child anxiety symptoms over the past three months; ≥25 is clinical anxiety
Time frame: through study completion, an average of 9 weeks
Self-Efficacy Chronic Pain Scale- Parent Version
Parent reported child self-efficacy during pain
Time frame: through study completion, an average of 9 weeks
Medication use
current medication use will be obtained via medical chart review and parent report
Time frame: through study completion, an average of 9 weeks
Affective Reactivity Index- Parent- Report
7-item measure of child emotional regulation
Time frame: through study completion, an average of 9 weeks
Adverse Childhood Events (ACEs)
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
COVID-19 Exposure and Family Impact Survey (CEFIS)
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
Child COVID-19 Related Distress
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.
Time frame: through study completion, an average of 9 weeks
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