- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03518216
Neural Mechanisms of Treatment Response to ADAPT
April 16, 2024 updated by: Natoshia Cunningham, Michigan State University
Using fMRI to Understand Response to an Integrative Treatment for Pain and Anxiety in Pediatric Functional Abdominal Pain Disorders (FAPD)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
49
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michigan
-
Grand Rapids, Michigan, United States, 49503
- Michigan State University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
9 years to 14 years (Child)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ADAPT
Participants randomized to ADAPT will complete Aim to Decrease Anxiety and Pain Treatment (ADAPT), a remotely delivered tailored intervention that integrates mindfulness meditation with cognitive behavioral therapy.
It consists of 6 sessions and blends pain and anxiety coping strategies.
The first 2 sessions are interactive with a trained psychological provider and the following 4 sessions are web-based.
Each web-based session is followed by therapist support.
|
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.
|
No Intervention: Waitlist Control
Participants randomized to waitlist control will receive medical treatment as usual.
These participants will be given the opportunity to complete ADAPT upon completion of the post assessment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
through study completion, an average of 9 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
through study completion, an average of 9 weeks
|
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
|
through study completion, an average of 9 weeks
|
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
|
through study completion, an average of 9 weeks
|
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
|
through study completion, an average of 9 weeks
|
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
|
through study completion, an average of 9 weeks
|
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.
|
through study completion, an average of 9 weeks
|
Functional Disability Inventory
Time Frame: through study completion, an average of 9 weeks
|
A 15-item self report inventory measuring perceived pain-related disability
|
through study completion, an average of 9 weeks
|
Rome IV Diagnosis Checklist
Time Frame: at screening to determine eligibility
|
Physician reported FAPD criteria (based on the Rome IV) met by the patient
|
at screening to determine eligibility
|
MRI Safety and Screening
Time Frame: at screening to determine eligibility
|
Utilized to determine if patient can safely complete fMRI protocol
|
at screening to determine eligibility
|
Self-Efficacy Pain Scale- Child Version
Time Frame: through study completion, an average of 9 weeks
|
Measure of child self-efficacy when in pain
|
through study completion, an average of 9 weeks
|
Affective Reactivity Index- Self Report
Time Frame: through study completion, an average of 9 weeks
|
7-item measure of emotional regulation
|
through study completion, an average of 9 weeks
|
Pain Catastrophizing Scale for Children
Time Frame: through study completion, an average of 9 weeks
|
Maladaptive beliefs about pain and long-term processes
|
through study completion, an average of 9 weeks
|
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
|
through study completion, an average of 9 weeks
|
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.
|
through study completion, an average of 9 weeks
|
NIH Promis Pain Interference
Time Frame: through study completion, an average of 9 weeks
|
Measure of functional impairment due to pediatric pain
|
through study completion, an average of 9 weeks
|
Peterson Pubertal Development Scale
Time Frame: through study completion, an average of 9 weeks
|
Pubertal status assessed via clinical interview
|
through study completion, an average of 9 weeks
|
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
|
through study completion, an average of 9 weeks
|
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
|
through study completion, an average of 9 weeks
|
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
|
through study completion, an average of 9 weeks
|
Depression Anxiety Stress Scales
Time Frame: through study completion, an average of 9 weeks
|
Measure of caregiver depression, anxiety, and tension/stress.
|
through study completion, an average of 9 weeks
|
Pain Catastrophizing Scale
Time Frame: through study completion, an average of 9 weeks
|
Maladaptive beliefs about pain and long-term outcomes completed by caregiver
|
through study completion, an average of 9 weeks
|
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
|
through study completion, an average of 9 weeks
|
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
|
through study completion, an average of 9 weeks
|
Self-Efficacy Chronic Pain Scale- Parent Version
Time Frame: through study completion, an average of 9 weeks
|
Parent reported child self-efficacy during pain
|
through study completion, an average of 9 weeks
|
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
|
through study completion, an average of 9 weeks
|
Affective Reactivity Index- Parent- Report
Time Frame: through study completion, an average of 9 weeks
|
7-item measure of child emotional regulation
|
through study completion, an average of 9 weeks
|
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.
|
through study completion, an average of 9 weeks
|
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.
|
through study completion, an average of 9 weeks
|
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.
|
through study completion, an average of 9 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Natoshia Cunningham, PhD, Michigan State University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 3, 2018
Primary Completion (Actual)
April 3, 2024
Study Completion (Actual)
April 3, 2024
Study Registration Dates
First Submitted
April 20, 2018
First Submitted That Met QC Criteria
May 4, 2018
First Posted (Actual)
May 8, 2018
Study Record Updates
Last Update Posted (Actual)
April 17, 2024
Last Update Submitted That Met QC Criteria
April 16, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-4545
- K23AT009458 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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