Functional Abdominal Pain SyndromeNCT03518216
Neural Mechanisms of Treatment Response to ADAPT
A study testing ADAPT in people with Functional Abdominal Pain Syndrome and Anxiety, run by Michigan State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 11 to 16 years
- Conditions the study is for
- Functional Abdominal Pain Syndrome, Anxiety
- What is being tested?
- ADAPT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jul 2018to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Michigan State University
Grand Rapids, Michigan, 49503
About this study
Official title: 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.
Read the 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.
- Conditions
- Functional Abdominal Pain Syndrome, Anxiety
- Being tested
- ADAPT
- Keywords
- cognitive behavioral therapy, mindfulness meditation, fMRI, neuroimaging
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADAPTBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| ADAPT | Experimental | 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. Receives: Behavioral: ADAPT |
| Waitlist Control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Functional Connectivity of Amygdala with the Prefrontal Cortex
Changes in functional connectivity will be examined using the Blood Oxygenation Level Dependent (BOLD) effect
Measured: through study completion, an average of 9 weeks
Secondary outcomes (29)
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)
Measured: through study completion, an average of 9 weeks
Neuroimaging data linked to pain and anxiety outcomes
Changes in functional connectivity/regional brain activation will correspond with changes in pain and anxiety
Measured: through study completion, an average of 9 weeks
Pain Intensity/Unpleasantness via Visual Analog Scale
State pain intensity and unpleasantness levels using a 0 - 10 scale
Measured: through study completion, an average of 9 weeks
State Anxiety
0 - 10 self-report of how anxious the child is feeling in the present moment
Measured: through study completion, an average of 9 weeks
Screen for Child Anxiety Related Disorders
Patient-reported measure of anxiety symptoms over the past 3 months
Measured: through study completion, an average of 9 weeks
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.
Measured: through study completion, an average of 9 weeks
Functional Disability Inventory
A 15-item self report inventory measuring perceived pain-related disability
Measured: through study completion, an average of 9 weeks
Rome IV Diagnosis Checklist
Physician reported FAPD criteria (based on the Rome IV) met by the patient
Measured: at screening to determine eligibility
MRI Safety and Screening
Utilized to determine if patient can safely complete fMRI protocol
Measured: at screening to determine eligibility
Self-Efficacy Pain Scale- Child Version
Measure of child self-efficacy when in pain
Measured: through study completion, an average of 9 weeks
Affective Reactivity Index- Self Report
7-item measure of emotional regulation
Measured: through study completion, an average of 9 weeks
Pain Catastrophizing Scale for Children
Maladaptive beliefs about pain and long-term processes
Measured: through study completion, an average of 9 weeks
Children's Depression Inventory 2
A measure of depressive symptoms in the past 2 weeks
Measured: through study completion, an average of 9 weeks
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.
Measured: through study completion, an average of 9 weeks
NIH Promis Pain Interference
Measure of functional impairment due to pediatric pain
Measured: through study completion, an average of 9 weeks
Peterson Pubertal Development Scale
Pubertal status assessed via clinical interview
Measured: through study completion, an average of 9 weeks
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
Measured: through study completion, an average of 9 weeks
Fullness Rating Scale
Youth will use scale to indicate how full they feel before and after water ingestion
Measured: through study completion, an average of 9 weeks
Child Pain History
Demographic factors, school absences, and pain duration, location, etc via caregiver report
Measured: through study completion, an average of 9 weeks
Depression Anxiety Stress Scales
Measure of caregiver depression, anxiety, and tension/stress.
Measured: through study completion, an average of 9 weeks
Pain Catastrophizing Scale
Maladaptive beliefs about pain and long-term outcomes completed by caregiver
Measured: through study completion, an average of 9 weeks
Screen for Child Anxiety Related Disorders- Parent Report
Parent-reported child anxiety symptoms over the past three months; ≥25 is clinical anxiety
Measured: through study completion, an average of 9 weeks
Functional Disability Inventory- Parent Report
Parent-reported child anxiety symptoms over the past three months; ≥25 is clinical anxiety
Measured: through study completion, an average of 9 weeks
Self-Efficacy Chronic Pain Scale- Parent Version
Parent reported child self-efficacy during pain
Measured: through study completion, an average of 9 weeks
Medication use
current medication use will be obtained via medical chart review and parent report
Measured: through study completion, an average of 9 weeks
Affective Reactivity Index- Parent- Report
7-item measure of child emotional regulation
Measured: through study completion, an average of 9 weeks
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.
Measured: through study completion, an average of 9 weeks
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.
Measured: through study completion, an average of 9 weeks
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.
Measured: through study completion, an average of 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2018
- Study start3 Jul 2018
- Primary completion3 Apr 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Functional Abdominal Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), Corewell Health West
- Responsible party
- Principal investigator, Natoshia Cunningham, Michigan State University
- Investigators
- Natoshia Cunningham, PhD, Principal investigator, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03518216
- Sponsor's protocol ID
- 2017-4545
- Other IDs
- K23AT009458
- Status last verified
- Apr 2024
- First submitted
- 20 Apr 2018
- Last updated
- 30 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cunningham NR, Adler MA, Barber Garcia BN, Abounader T, Miller AK, Monzalvo M, Hashemi I, Cox R, Ely SL, Zhou Y, DeLano M, Mulderink T, Reeves MJ, Peugh JL, Kashikar-Zuck S, Coghill RC, Arnetz JE, Zhu DC. Study protocol for a pilot clinical trial to understand neural mechanisms of response to a psychological treatment for pain and anxiety in pediatric functional abdominal pain disorders (FAPD). PLoS One. 2024 Mar 18;19(3):e0299170. doi: 10.1371/journal.pone.0299170. eCollection 2024.
PubMed 38498587
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using fMRI to Understand Response to an Integrative Treatment for Pain and Anxiety in Pediatric Functional Abdominal Pain Disorders (FAPD)
- ClinicalTrials.gov ID
- NCT03518216
- Acronym / sponsor ID
- 2017-4545
- Conditions
- Functional Abdominal Pain Syndrome, Anxiety
- Keywords
- cognitive behavioral therapy, mindfulness meditation, fMRI, neuroimaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), Corewell Health West
- Study start
- 3 Jul 2018 (actual)
- Primary completion
- 3 Apr 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 8 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADAPT | Experimental | Behavioral: ADAPTParticipants 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. |
| Waitlist Control | No intervention | –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. |
Who may qualify
- Ages
- 11 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADAPTAim 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. | Behavioural | ADAPT |
Primary outcome
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
29 secondary outcomes
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
Neuroimaging data linked to pain and anxiety outcomes
Time frame: 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 Anxiety
Time frame: through study completion, an average of 9 weeks
Screen for Child Anxiety Related Disorders
Time frame: through study completion, an average of 9 weeks
Generalized Anxiety Disorders 7 (GAD-7)
Time frame: through study completion, an average of 9 weeks
Functional Disability Inventory
Time frame: through study completion, an average of 9 weeks
Rome IV Diagnosis Checklist
Time frame: at screening to determine eligibility
MRI Safety and Screening
Time frame: at screening to determine eligibility
Self-Efficacy Pain Scale- Child Version
Time frame: through study completion, an average of 9 weeks
Affective Reactivity Index- Self Report
Time frame: through study completion, an average of 9 weeks
Pain Catastrophizing Scale for Children
Time frame: through study completion, an average of 9 weeks
Children's Depression Inventory 2
Time frame: through study completion, an average of 9 weeks
Patient Health Questionnaire 9
Time frame: through study completion, an average of 9 weeks
NIH Promis Pain Interference
Time frame: through study completion, an average of 9 weeks
Peterson Pubertal Development Scale
Time frame: through study completion, an average of 9 weeks
Edinburgh Handedness Inventory
Time frame: through study completion, an average of 9 weeks
Fullness Rating Scale
Time frame: through study completion, an average of 9 weeks
Child Pain History
Time frame: through study completion, an average of 9 weeks
Depression Anxiety Stress Scales
Time frame: through study completion, an average of 9 weeks
Pain Catastrophizing Scale
Time frame: 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
Functional Disability Inventory- Parent Report
Time frame: 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
Medication use
Time frame: through study completion, an average of 9 weeks
Affective Reactivity Index- Parent- Report
Time frame: through study completion, an average of 9 weeks
Adverse Childhood Events (ACEs)
Time frame: 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
Child COVID-19 Related Distress
Time frame: through study completion, an average of 9 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2025.
- Derived from this study: PubMed 38498587Cunningham NR, Adler MA, Barber Garcia BN, Abounader T, Miller AK, Monzalvo M, Hashemi I, Cox R, Ely SL, Zhou Y, DeLano M, Mulderink T, Reeves MJ, Peugh JL, Kashikar-Zuck S, Coghill RC, Arnetz JE, Zhu DC. Study protocol for a pilot clinical trial to understand neural mechanisms of response to a psychological treatment for pain and anxiety in pediatric functional abdominal pain disorders (FAPD). PLoS One. 2024 Mar 18;19(3):e0299170. doi: 10.1371/journal.pone.0299170. eCollection 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natoshia Cunningham, PhD principal investigator
Michigan State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ADAPT in people with Functional Abdominal Pain Syndrome and Anxiety, run by Michigan State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Connectivity of Amygdala with the Prefrontal Cortex (time frame: through study completion, an average of 9 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03518216, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2025.