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Neural Mechanisms of Treatment Response to ADAPT

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ClinicalTrials.gov Identifier: NCT03518216
Recruitment Status : Recruiting
First Posted : May 8, 2018
Last Update Posted : July 24, 2018
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

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.

Condition or disease Intervention/treatment Phase
Functional Abdominal Pain Syndrome Anxiety Behavioral: ADAPT Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 93 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Using fMRI to Understand Response to an Integrative Treatment for Pain and Anxiety in Pediatric Functional Abdominal Pain Disorders (FAPD)
Actual Study Start Date : July 3, 2018
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ADAPT
Participants randomized to ADAPT will complete Aim to Decrease Anxiety and Pain Treatment (ADAPT),a 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 in person with a trained psychological provider and the following 4 sessions are web-based. Each web-based session is followed by therapist phone support.
Behavioral: ADAPT
Aim to Decrease Anxiety and Pain Treatment is a 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 in person with a trained psychological provider and the following 4 sessions will be web-based. Each web-based session will be followed by therapist phone support.

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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)

  2. 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

  3. 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

  4. 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

  5. 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

  6. Functional Disability Inventory [ Time Frame: through study completion, an average of 9 weeks ]
    A 15-item self report inventory measuring perceived pain-related disability

  7. Rome IV Diagnosis Checklist [ Time Frame: at screening to determine eligibility ]
    Physician reported FAPD criteria (based on the Rome IV) met by the patient

  8. MRI Safety and Screening [ Time Frame: at screening to determine eligibility ]
    Utilized to determine if patient can safely complete fMRI protocol

  9. Self-Efficacy Pain Scale- Child Version [ Time Frame: through study completion, an average of 9 weeks ]
    Measure of child self-efficacy when in pain

  10. Affective Reactivity Index- Self Report [ Time Frame: through study completion, an average of 9 weeks ]
    7-item measure of emotional regulation

  11. Pain Catastrophizing Scale for Children [ Time Frame: through study completion, an average of 9 weeks ]
    Maladaptive beliefs about pain and long-term processes

  12. 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

  13. NIH Promis Pain Interference [ Time Frame: through study completion, an average of 9 weeks ]
    Measure of functional impairment due to pediatric pain

  14. Peterson Pubertal Development Scale [ Time Frame: through study completion, an average of 9 weeks ]
    Pubertal status assessed via clinical interview

  15. 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

  16. 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

  17. 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

  18. Depression Anxiety Stress Scales [ Time Frame: through study completion, an average of 9 weeks ]
    Measure of caregiver depression, anxiety, and tension/stress.

  19. Pain Catastrophizing Scale [ Time Frame: through study completion, an average of 9 weeks ]
    Maladaptive beliefs about pain and long-term outcomes completed by caregiver

  20. 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

  21. 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

  22. Self-Efficacy Chronic Pain Scale- Parent Version [ Time Frame: through study completion, an average of 9 weeks ]
    Parent reported child self-efficacy during pain

  23. 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

  24. Affective Reactivity Index- Parent- Report [ Time Frame: through study completion, an average of 9 weeks ]
    7-item measure of child emotional regulation



Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 Screen for Child Anxiety Related Disorders [SCARED] cut-off score ≥25).
  • Sufficient English language ability necessary to complete study measures and protocol.
  • Meets criteria for presence of greater than minimal disability (based on Functional Disability Inventory [FDI] cut off ≥8)
  • Meets criteria for greater than minimal pain (based on Pain Intensity Visual Analog Scale [VAS] cut off ≥3)

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 (T score ≥80) or active suicidal ideation reported on the CDI during the baseline assessment.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03518216


Contacts
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Contact: Natoshia Cunningham, PhD 513-636-2403 Natoshia.Cunningham@cchmc.org
Contact: Christine Le, BA 513-803-7584 Christine.Le@cchmc.org

Locations
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United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Natoshia Cunningham, PhD    513-636-2403    natoshia.cunningham@cchmc.org   
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
National Center for Complementary and Integrative Health (NCCIH)
  Study Documents (Full-Text)

Documents provided by Children's Hospital Medical Center, Cincinnati:

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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT03518216     History of Changes
Other Study ID Numbers: 2017-4545
K23AT009458 ( U.S. NIH Grant/Contract )
First Posted: May 8, 2018    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Children's Hospital Medical Center, Cincinnati:
cognitive behavioral therapy
mindfulness meditation
fMRI
neuroimaging
Additional relevant MeSH terms:
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Abdominal Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Signs and Symptoms, Digestive