Clinical trial NCT03518216: Neural Mechanisms of Treatment Response to ADAPT
Official title: Using fMRI to Understand Response to an Integrative Treatment for Pain and Anxiety in Pediatric Functional Abdominal Pain Disorders (FAPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Functional Abdominal Pain Syndrome
Anxiety
Keywords: cognitive behavioral therapy
mindfulness meditation
fMRI
neuroimaging
Lead sponsor: Michigan State University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
name: Spectrum Health Hospitals
First posted: 2018-05-08
Enrollment: 49
Sex: ALL
Minimum age (years): 11
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Functional Connectivity of Amygdala with the Prefrontal Cortex
timeFrame: through study completion, an average of 9 weeks
Secondary outcomes:
measure: Regional Brain Activation in Areas Associated with Cognitive, Affective, and Visceral Afferent Aspects of Pain
timeFrame: through study completion, an average of 9 weeks
measure: Neuroimaging data linked to pain and anxiety outcomes
timeFrame: through study completion, an average of 9 weeks
measure: Pain Intensity/Unpleasantness via Visual Analog Scale
timeFrame: through study completion, an average of 9 weeks
measure: State Anxiety
timeFrame: through study completion, an average of 9 weeks
measure: Screen for Child Anxiety Related Disorders
timeFrame: through study completion, an average of 9 weeks
measure: Generalized Anxiety Disorders 7 (GAD-7)
timeFrame: through study completion, an average of 9 weeks
measure: Functional Disability Inventory
timeFrame: through study completion, an average of 9 weeks
measure: Rome IV Diagnosis Checklist
timeFrame: at screening to determine eligibility
measure: MRI Safety and Screening
timeFrame: at screening to determine eligibility
measure: Self-Efficacy Pain Scale- Child Version
timeFrame: through study completion, an average of 9 weeks
measure: Affective Reactivity Index- Self Report
timeFrame: through study completion, an average of 9 weeks
measure: Pain Catastrophizing Scale for Children
timeFrame: through study completion, an average of 9 weeks
measure: Children's Depression Inventory 2
timeFrame: through study completion, an average of 9 weeks
measure: Patient Health Questionnaire 9
timeFrame: through study completion, an average of 9 weeks
measure: NIH Promis Pain Interference
timeFrame: through study completion, an average of 9 weeks
measure: Peterson Pubertal Development Scale
timeFrame: through study completion, an average of 9 weeks
measure: Edinburgh Handedness Inventory
timeFrame: through study completion, an average of 9 weeks
measure: Fullness Rating Scale
timeFrame: through study completion, an average of 9 weeks
measure: Child Pain History
timeFrame: through study completion, an average of 9 weeks
measure: Depression Anxiety Stress Scales
timeFrame: through study completion, an average of 9 weeks
measure: Pain Catastrophizing Scale
timeFrame: through study completion, an average of 9 weeks
measure: Screen for Child Anxiety Related Disorders- Parent Report
timeFrame: through study completion, an average of 9 weeks
measure: Functional Disability Inventory- Parent Report
timeFrame: through study completion, an average of 9 weeks
measure: Self-Efficacy Chronic Pain Scale- Parent Version
timeFrame: through study completion, an average of 9 weeks
measure: Medication use
timeFrame: through study completion, an average of 9 weeks
measure: Affective Reactivity Index- Parent- Report
timeFrame: through study completion, an average of 9 weeks
measure: Adverse Childhood Events (ACEs)
timeFrame: through study completion, an average of 9 weeks
measure: COVID-19 Exposure and Family Impact Survey (CEFIS)
timeFrame: through study completion, an average of 9 weeks
measure: Child COVID-19 Related Distress
timeFrame: through study completion, an average of 9 weeks
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: Michigan State University
state: Michigan
Study officials:
affiliation: Michigan State University
name: Natoshia Cunningham, PhD
role: PRINCIPAL_INVESTIGATOR
References: