Anxiety, Functional Abdominal Pain Syndrome
Conditions
Keywords
cognitive behavioral therapy, mindfulness meditation, fMRI, neuroimaging
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.
Interventions
BEHAVIORALADAPT
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.
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Corewell Health West
Michigan State University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
11 Years to 16 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional Connectivity of Amygdala with the Prefrontal Cortex | through study completion, an average of 9 weeks | Changes in functional connectivity will be examined using the Blood Oxygenation Level Dependent (BOLD) effect |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neuroimaging data linked to pain and anxiety outcomes | through study completion, an average of 9 weeks | Changes in functional connectivity/regional brain activation will correspond with changes in pain and anxiety |
| Pain Intensity/Unpleasantness via Visual Analog Scale | through study completion, an average of 9 weeks | State pain intensity and unpleasantness levels using a 0 - 10 scale |
| State Anxiety | through study completion, an average of 9 weeks | 0 - 10 self-report of how anxious the child is feeling in the present moment |
| Screen for Child Anxiety Related Disorders | through study completion, an average of 9 weeks | Patient-reported measure of anxiety symptoms over the past 3 months |
| Generalized Anxiety Disorders 7 (GAD-7) | 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. |
| Functional Disability Inventory | through study completion, an average of 9 weeks | A 15-item self report inventory measuring perceived pain-related disability |
| Rome IV Diagnosis Checklist | at screening to determine eligibility | Physician reported FAPD criteria (based on the Rome IV) met by the patient |
| MRI Safety and Screening | at screening to determine eligibility | Utilized to determine if patient can safely complete fMRI protocol |
| Self-Efficacy Pain Scale- Child Version | through study completion, an average of 9 weeks | Measure of child self-efficacy when in pain |
| Affective Reactivity Index- Self Report | through study completion, an average of 9 weeks | 7-item measure of emotional regulation |
| Pain Catastrophizing Scale for Children | through study completion, an average of 9 weeks | Maladaptive beliefs about pain and long-term processes |
| Children's Depression Inventory 2 | through study completion, an average of 9 weeks | A measure of depressive symptoms in the past 2 weeks |
| Patient Health Questionnaire 9 | 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. |
| NIH Promis Pain Interference | through study completion, an average of 9 weeks | Measure of functional impairment due to pediatric pain |
| Regional Brain Activation in Areas Associated with Cognitive, Affective, and Visceral Afferent Aspects of Pain | through study completion, an average of 9 weeks | Changes in regional brain activity will be assessed by arterial spin labeling (ASL) |
| Edinburgh Handedness Inventory | 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 |
| Fullness Rating Scale | through study completion, an average of 9 weeks | Youth will use scale to indicate how full they feel before and after water ingestion |
| Child Pain History | through study completion, an average of 9 weeks | Demographic factors, school absences, and pain duration, location, etc via caregiver report |
| Depression Anxiety Stress Scales | through study completion, an average of 9 weeks | Measure of caregiver depression, anxiety, and tension/stress. |
| Pain Catastrophizing Scale | through study completion, an average of 9 weeks | Maladaptive beliefs about pain and long-term outcomes completed by caregiver |
| Screen for Child Anxiety Related Disorders- Parent Report | through study completion, an average of 9 weeks | Parent-reported child anxiety symptoms over the past three months; ≥25 is clinical anxiety |
| Functional Disability Inventory- Parent Report | through study completion, an average of 9 weeks | Parent-reported child anxiety symptoms over the past three months; ≥25 is clinical anxiety |
| Self-Efficacy Chronic Pain Scale- Parent Version | through study completion, an average of 9 weeks | Parent reported child self-efficacy during pain |
| Medication use | through study completion, an average of 9 weeks | current medication use will be obtained via medical chart review and parent report |
| Affective Reactivity Index- Parent- Report | through study completion, an average of 9 weeks | 7-item measure of child emotional regulation |
| Adverse Childhood Events (ACEs) | 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. |
| COVID-19 Exposure and Family Impact Survey (CEFIS) | 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. |
| Child COVID-19 Related Distress | 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. |
| Peterson Pubertal Development Scale | through study completion, an average of 9 weeks | Pubertal status assessed via clinical interview |
Countries
United States
Outcome results
None listed