Neural Mechanisms of Treatment Response to ADAPT

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03518216
• Other study ID #: 2017-4545
• Secondary ID: K23AT009458
• Status: Completed
• Phase: N/A
• Start date: July 3, 2018
• Est. completion date: April 3, 2024

Study information

• Verified date: April 2024
• Source: Michigan State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: April 3, 2024
• Est. primary completion date: April 3, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Pain
• Anxiety
• Functional Abdominal Pain Syndrome

Intervention

Behavioral:
• ADAPT
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.

Locations

Country	Name	City	State
United States	Michigan State University	Grand Rapids	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
Michigan State University	National Center for Complementary and Integrative Health (NCCIH), Spectrum Health Hospitals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Connectivity of Amygdala with the Prefrontal Cortex	Changes in functional connectivity will be examined using the Blood Oxygenation Level Dependent (BOLD) effect	through study completion, an average of 9 weeks
Secondary	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)	through study completion, an average of 9 weeks
Secondary	Neuroimaging data linked to pain and anxiety outcomes	Changes in functional connectivity/regional brain activation will correspond with changes in pain and anxiety	through study completion, an average of 9 weeks
Secondary	Pain Intensity/Unpleasantness via Visual Analog Scale	State pain intensity and unpleasantness levels using a 0 - 10 scale	through study completion, an average of 9 weeks
Secondary	State Anxiety	0 - 10 self-report of how anxious the child is feeling in the present moment	through study completion, an average of 9 weeks
Secondary	Screen for Child Anxiety Related Disorders	Patient-reported measure of anxiety symptoms over the past 3 months	through study completion, an average of 9 weeks
Secondary	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.	through study completion, an average of 9 weeks
Secondary	Functional Disability Inventory	A 15-item self report inventory measuring perceived pain-related disability	through study completion, an average of 9 weeks
Secondary	Rome IV Diagnosis Checklist	Physician reported FAPD criteria (based on the Rome IV) met by the patient	at screening to determine eligibility
Secondary	MRI Safety and Screening	Utilized to determine if patient can safely complete fMRI protocol	at screening to determine eligibility
Secondary	Self-Efficacy Pain Scale- Child Version	Measure of child self-efficacy when in pain	through study completion, an average of 9 weeks
Secondary	Affective Reactivity Index- Self Report	7-item measure of emotional regulation	through study completion, an average of 9 weeks
Secondary	Pain Catastrophizing Scale for Children	Maladaptive beliefs about pain and long-term processes	through study completion, an average of 9 weeks
Secondary	Children's Depression Inventory 2	A measure of depressive symptoms in the past 2 weeks	through study completion, an average of 9 weeks
Secondary	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.	through study completion, an average of 9 weeks
Secondary	NIH Promis Pain Interference	Measure of functional impairment due to pediatric pain	through study completion, an average of 9 weeks
Secondary	Peterson Pubertal Development Scale	Pubertal status assessed via clinical interview	through study completion, an average of 9 weeks
Secondary	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	through study completion, an average of 9 weeks
Secondary	Fullness Rating Scale	Youth will use scale to indicate how full they feel before and after water ingestion	through study completion, an average of 9 weeks
Secondary	Child Pain History	Demographic factors, school absences, and pain duration, location, etc via caregiver report	through study completion, an average of 9 weeks
Secondary	Depression Anxiety Stress Scales	Measure of caregiver depression, anxiety, and tension/stress.	through study completion, an average of 9 weeks
Secondary	Pain Catastrophizing Scale	Maladaptive beliefs about pain and long-term outcomes completed by caregiver	through study completion, an average of 9 weeks
Secondary	Screen for Child Anxiety Related Disorders- Parent Report	Parent-reported child anxiety symptoms over the past three months; =25 is clinical anxiety	through study completion, an average of 9 weeks
Secondary	Functional Disability Inventory- Parent Report	Parent-reported child anxiety symptoms over the past three months; =25 is clinical anxiety	through study completion, an average of 9 weeks
Secondary	Self-Efficacy Chronic Pain Scale- Parent Version	Parent reported child self-efficacy during pain	through study completion, an average of 9 weeks
Secondary	Medication use	current medication use will be obtained via medical chart review and parent report	through study completion, an average of 9 weeks
Secondary	Affective Reactivity Index- Parent- Report	7-item measure of child emotional regulation	through study completion, an average of 9 weeks
Secondary	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.	through study completion, an average of 9 weeks
Secondary	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.	through study completion, an average of 9 weeks
Secondary	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.	through study completion, an average of 9 weeks