Neural Mechanisms of Treatment Response to ADAPT

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.

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 Screen for
Child Anxiety Related Disorders [SCARED] cut-off score ≥25).

- Sufficient English language ability necessary to complete study measures and protocol.

- Meets criteria for presence of greater than minimal disability (based on Functional
Disability Inventory [FDI] cut off ≥8)

- Meets criteria for greater than minimal pain (based on Pain Intensity Visual Analog
Scale [VAS] cut off ≥3)

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 (T score ≥80) or active suicidal ideation
reported on the CDI during the baseline assessment.

- 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.