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CompletedNCT02327377Updated Mar 28, 2019

Web-based Management of Pediatric Functional Abdominal Pain

An interventional study of Online Cognitive Behavior Therapy and Online Education in Gastrointestinal Disorders, Functional, sponsored by Vanderbilt University Medical Center. Completed at 1 site in United States. Open to participants aged 11 Years to 17 Years. Per ClinicalTrials.gov, last updated 2019-03-28.

Sponsored by Vanderbilt University Medical Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
344
Allocation
Randomized
Ages
11 Years to 17 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • 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
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In context

Gastrointestinal Diseases

639 studies on the registry are indexed under Gastrointestinal Diseases; 126 are open to participants now.

This study's enrollment of 344 is above the median of 77 across 428 interventional studies indexed under Gastrointestinal Diseases.

Browse Gastrointestinal Diseases studies →

Lead sponsor

Vanderbilt University Medical Center is the lead sponsor of 833 studies on the registry; 159 are open to participants now.

Of its 124 completed or terminated interventional studies of FDA-regulated products, 92 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
11 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
344 participants (actual)

Study arms

  • Experimental
    Online Cognitive Behavior Therapy

    Online cognitive behavior therapy for coping with pain

    Behavioral: Online Cognitive Behavior Therapy

  • Active comparator
    Online Education

    Educational information about pain

    Behavioral: Online Education

Interventions

  • BehavioralOnline Cognitive Behavior Therapy
  • BehavioralOnline Education
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What researchers measure

Primary outcomes

  1. Change from baseline somatic symptoms

    Change from baseline somatic symptoms as measured by the Children's Somatization Inventory

    Time frame: 2 months after baseline

  2. Change from baseline abdominal pain

    Change from baseline abdominal pain as measured by Abdominal Pain Index

    Time frame: long-term follow-up (6 and 12 months after baseline)

Secondary outcomes

  1. Change from baseline activity limitations

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

    Time frame: 2 months after baseline

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Study locations

1 site
  • Vanderbilt Children's Hospital
    Nashville, Tennessee 37232, United States
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References and documents

Publications

  • 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. PubMed 34793406 ↗

Study documents

  • Informed consent form · Feb 5, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 28, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02327377
Responsible party
Lynn Walker (Professor of Pediatrics; Division Director, Adolescent & Young Adult Health, Vanderbilt University Medical Center) — Principal investigator
First posted
Dec 30, 2014
Start date
Apr 2014
Primary completion
Jan 16, 2019
Completion
Jan 28, 2019
Last update
Mar 28, 2019

Study contacts

Lynn Walker, PhD
principal investigator · Vanderbilt University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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