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Completed

NCT Number: NCT03518216

Neural Mechanisms of Treatment Response to ADAPT

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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Key information

Age range

11 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Michigan State University

Grand Rapids, Michigan, 49503, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

ADAPT

Behavioral

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.

Primary outcomes

  1. Functional Connectivity of Amygdala with the Prefrontal Cortex

    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

Secondary outcomes

  1. Regional Brain Activation in Areas Associated with Cognitive, Affective, and Visceral Afferent Aspects of Pain

    Time frame: through study completion, an average of 9 weeks

    Changes in regional brain activity will be assessed by arterial spin labeling (ASL)

  2. Neuroimaging data linked to pain and anxiety outcomes

    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

  3. Pain Intensity/Unpleasantness via Visual Analog Scale

    Time frame: through study completion, an average of 9 weeks

    State pain intensity and unpleasantness levels using a 0 - 10 scale

  4. State Anxiety

    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

  5. Screen for Child Anxiety Related Disorders

    Time frame: through study completion, an average of 9 weeks

    Patient-reported measure of anxiety symptoms over the past 3 months

  6. Generalized Anxiety Disorders 7 (GAD-7)

    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.

  7. Functional Disability Inventory

    Time frame: through study completion, an average of 9 weeks

    A 15-item self report inventory measuring perceived pain-related disability

  8. Rome IV Diagnosis Checklist

    Time frame: at screening to determine eligibility

    Physician reported FAPD criteria (based on the Rome IV) met by the patient

  9. MRI Safety and Screening

    Time frame: at screening to determine eligibility

    Utilized to determine if patient can safely complete fMRI protocol

  10. Self-Efficacy Pain Scale- Child Version

    Time frame: through study completion, an average of 9 weeks

    Measure of child self-efficacy when in pain

  11. Affective Reactivity Index- Self Report

    Time frame: through study completion, an average of 9 weeks

    7-item measure of emotional regulation

  12. Pain Catastrophizing Scale for Children

    Time frame: through study completion, an average of 9 weeks

    Maladaptive beliefs about pain and long-term processes

  13. Children's Depression Inventory 2

    Time frame: through study completion, an average of 9 weeks

    A measure of depressive symptoms in the past 2 weeks

  14. Patient Health Questionnaire 9

    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.

  15. NIH Promis Pain Interference

    Time frame: through study completion, an average of 9 weeks

    Measure of functional impairment due to pediatric pain

  16. Peterson Pubertal Development Scale

    Time frame: through study completion, an average of 9 weeks

    Pubertal status assessed via clinical interview

  17. Edinburgh Handedness Inventory

    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

  18. Fullness Rating Scale

    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

  19. Child Pain History

    Time frame: through study completion, an average of 9 weeks

    Demographic factors, school absences, and pain duration, location, etc via caregiver report

  20. Depression Anxiety Stress Scales

    Time frame: through study completion, an average of 9 weeks

    Measure of caregiver depression, anxiety, and tension/stress.

  21. Pain Catastrophizing Scale

    Time frame: through study completion, an average of 9 weeks

    Maladaptive beliefs about pain and long-term outcomes completed by caregiver

  22. Screen for Child Anxiety Related Disorders- Parent Report

    Time frame: through study completion, an average of 9 weeks

    Parent-reported child anxiety symptoms over the past three months; ≥25 is clinical anxiety

  23. Functional Disability Inventory- Parent Report

    Time frame: through study completion, an average of 9 weeks

    Parent-reported child anxiety symptoms over the past three months; ≥25 is clinical anxiety

  24. Self-Efficacy Chronic Pain Scale- Parent Version

    Time frame: through study completion, an average of 9 weeks

    Parent reported child self-efficacy during pain

  25. Medication use

    Time frame: through study completion, an average of 9 weeks

    current medication use will be obtained via medical chart review and parent report

  26. Affective Reactivity Index- Parent- Report

    Time frame: through study completion, an average of 9 weeks

    7-item measure of child emotional regulation

  27. Adverse Childhood Events (ACEs)

    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.

  28. COVID-19 Exposure and Family Impact Survey (CEFIS)

    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.

  29. Child COVID-19 Related Distress

    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.

Sponsors and collaborators

Lead sponsor

Michigan State University

Other

Collaborators

  • Corewell Health West
  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

Using fMRI to Understand Response to an Integrative Treatment for Pain and Anxiety in Pediatric Functional Abdominal Pain Disorders (FAPD)

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
May 8, 2018
Registry last updated
Oct 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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