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Web-based Management of Pediatric Functional Abdominal Pain

Primary Purpose

Gastrointestinal Disorders, Functional

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Online Cognitive Behavior Therapy
Online Education
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastrointestinal Disorders, Functional focused on measuring Irritable bowel syndrome, Intervention studies, Visceral pain, Chronic pain, Abdominal pain, Dyspepsia, Nausea, Nociception, Parents, Coping behavior, Anxiety, Depression, Catastrophization, Reinforcement (psychology), Self efficacy, Health services overutilization, Questionnaires, Self report, Health surveys, Prospective studies, Adolescent health, Mental health services, Health services accessibility, Health diaries, National Institute of Child Health & Human Development (US.), Telemedicine, E-Health, Web-based intervention, Parenting education

Eligibility Criteria

11 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Referred for medical evaluation of abdominal pain of more than 3 months duration
  • No prior diagnosis of organic disease that explains the pain
  • Access to a computer and the internet

Exclusion Criteria:

  • Presence of major medical condition (e.g., diabetes)
  • Does not speak English
  • Has a disability that precludes participation
  • Does not have a participating parent/guardian
  • Found to have significant organic disease (e.g., ulcerative colitis) in the medical evaluation

Sites / Locations

  • Vanderbilt Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Online Cognitive Behavior Therapy

Online Education

Arm Description

Online cognitive behavior therapy for coping with pain

Educational information about pain

Outcomes

Primary Outcome Measures

Change from baseline somatic symptoms
Change from baseline somatic symptoms as measured by the Children's Somatization Inventory
Change from baseline abdominal pain
Change from baseline abdominal pain as measured by Abdominal Pain Index

Secondary Outcome Measures

Change from baseline activity limitations
Change from baseline activity limitations as measured by the Patient Reported Outcomes Measurement Information System Pain Interference Scale

Full Information

First Posted
December 10, 2014
Last Updated
March 25, 2019
Sponsor
Vanderbilt University Medical Center
Collaborators
Seattle Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02327377
Brief Title
Web-based Management of Pediatric Functional Abdominal Pain
Official Title
Predicting Treatment Outcomes in Pediatric Functional Abdominal Pain
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
January 16, 2019 (Actual)
Study Completion Date
January 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
Collaborators
Seattle Children's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Functional abdominal pain (FAP), a pediatric pain condition without significant organic pathology, is a precursor to chronic pain and high healthcare utilization in young adulthood. This project aims to identify child and family characteristics that predict differential responses to a Cognitive Behavior Therapy intervention administered online to patients with FAP and their parents. The goal is to acquire scientific knowledge to guide individualized treatment of patients with FAP.
Detailed Description
The goal of our research is to identify individual differences in pediatric functional abdominal pain (FAP) that predict differential health outcomes and can be used to develop tailored approaches to the evaluation and treatment of FAP. Effective treatment of FAP is a critical public health issue because it is among the most common pain problems during childhood and prospectively predicts risk for chronic pain, disability, and frequent health service utilization (HSU) in early adulthood. Although cognitive behavior therapy (CBT) delivered by highly trained professionals in face-to-face sessions has been found to reduce pain in some FAP patients, such intensive resources are not generally available to the large population of FAP patients. This study will evaluate an alternative, more efficient approach to treating pediatric FAP. The study builds on and integrates recent work by two leading investigators in pediatric pain. First, in a prospective natural history study of pediatric onset FAP patients followed into late adolescence/early adulthood, PI Walker and colleagues identified three distinct patient profiles (i.e., Low Pain Adaptive, High Pain Adaptive, High Pain Dysfunctional) comprised of pain severity, pain cognitions, and affect at the time of the initial FAP evaluation in childhood. These profiles predicted chronic pain and related health outcomes at follow-up (FU) nearly a decade later. Patients with the High Pain Dysfunctional profile at baseline had the poorest symptom outcomes and also exhibited pro-nociceptive central pain modulation in laboratory pain testing at FU. The heterogeneity of the FAP pain profile groups suggests that they may differ in treatment needs and in the extent to which they benefit significantly more from adjunctive behavioral treatment as compared to usual care alone. Second, Co-Investigator Palermo developed and tested a CBT intervention delivered online (Web-based Management of Adolescent Pain; Web-MAP) which is an efficient, easily disseminated treatment that significantly reduced pain and disability in youth with a variety of chronic pain diagnoses in comparison to youth randomized to a usual care, wait-list control group. This study merges these lines of research into an innovative study that will, for the first time: (Aim 1) evaluate the efficacy of WebMAP administered to FAP patients and their parents; (Aim 2) evaluate baseline moderators of treatment response, including our previously validated FAP pain profiles, pro-nociceptive central pain modulation, and parent characteristics (protectiveness, modeling pain behavior, catastrophizing about the child's pain); and (Aim 3) evaluate potential mediators of the effect of WebMAP on health outcomes. Pediatric patients (n = 300) ages 11-17 years will be randomized to either WebMAP or a Usual Care (UC) control group following their initial subspecialty FAP evaluation. Assessments will be at baseline, mid- and post-treatment, and at 6- and 12-months post baseline. Study results will produce knowledge that can be used to more efficiently target interventions to FAP patients according to their individual needs and thereby extend evidence-based care to more patients and ultimately reduce overall costs of care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Disorders, Functional
Keywords
Irritable bowel syndrome, Intervention studies, Visceral pain, Chronic pain, Abdominal pain, Dyspepsia, Nausea, Nociception, Parents, Coping behavior, Anxiety, Depression, Catastrophization, Reinforcement (psychology), Self efficacy, Health services overutilization, Questionnaires, Self report, Health surveys, Prospective studies, Adolescent health, Mental health services, Health services accessibility, Health diaries, National Institute of Child Health & Human Development (US.), Telemedicine, E-Health, Web-based intervention, Parenting education

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
344 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Online Cognitive Behavior Therapy
Arm Type
Experimental
Arm Description
Online cognitive behavior therapy for coping with pain
Arm Title
Online Education
Arm Type
Active Comparator
Arm Description
Educational information about pain
Intervention Type
Behavioral
Intervention Name(s)
Online Cognitive Behavior Therapy
Intervention Type
Behavioral
Intervention Name(s)
Online Education
Primary Outcome Measure Information:
Title
Change from baseline somatic symptoms
Description
Change from baseline somatic symptoms as measured by the Children's Somatization Inventory
Time Frame
2 months after baseline
Title
Change from baseline abdominal pain
Description
Change from baseline abdominal pain as measured by Abdominal Pain Index
Time Frame
long-term follow-up (6 and 12 months after baseline)
Secondary Outcome Measure Information:
Title
Change from baseline activity limitations
Description
Change from baseline activity limitations as measured by the Patient Reported Outcomes Measurement Information System Pain Interference Scale
Time Frame
2 months after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Referred for medical evaluation of abdominal pain of more than 3 months duration No prior diagnosis of organic disease that explains the pain Access to a computer and the internet Exclusion Criteria: Presence of major medical condition (e.g., diabetes) Does not speak English Has a disability that precludes participation Does not have a participating parent/guardian Found to have significant organic disease (e.g., ulcerative colitis) in the medical evaluation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lynn Walker, PhD
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt Children's Hospital
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34793406
Citation
Walker LS, Stone AL, Han GT, Garber J, Bruehl S, Smith CA, Anderson J, Palermo TM. Internet-delivered cognitive behavioral therapy for youth with functional abdominal pain: a randomized clinical trial testing differential efficacy by patient subgroup. Pain. 2021 Dec 1;162(12):2945-2955. doi: 10.1097/j.pain.0000000000002288.
Results Reference
derived

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Web-based Management of Pediatric Functional Abdominal Pain

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