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Gastrointestinal Disorders, FunctionalNCT02327377

Web-based Management of Pediatric Functional Abdominal Pain

A study testing Online Cognitive Behavior Therapy and Online Education in people with Gastrointestinal Disorders, Functional, run by Vanderbilt University Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 11 to 17 years
Conditions the study is for
Gastrointestinal Disorders, Functional
What is being tested?
Online Cognitive Behavior Therapy and Online Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
344 participants
Where
1 siteUnited States
Study dates
Apr 2014to 28 Jan 2019
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 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Vanderbilt Children's Hospital

    Nashville, Tennessee, 37232

Other trials in United States

About this study

Official title: Predicting Treatment Outcomes in Pediatric Functional Abdominal Pain

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.

Being tested
Online Cognitive Behavior Therapy, Online Education
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
Medical subject headings
Gastrointestinal Diseases, Irritable Bowel Syndrome, Visceral Pain, Chronic Pain, Abdominal Pain, Dyspepsia, Nausea, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Online Cognitive Behavior TherapyBehavioural

  • Online EducationBehavioural

Study groups in NCT02327377
Study groupRoleWhat they receive
Online Cognitive Behavior TherapyExperimentalOnline cognitive behavior therapy for coping with pain
Receives: Behavioral: Online Cognitive Behavior Therapy
Online EducationActive comparatorEducational information about pain
Receives: Behavioral: Online Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline somatic symptoms

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

    Measured: 2 months after baseline

  2. Change from baseline abdominal pain

    Change from baseline abdominal pain as measured by Abdominal Pain Index

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

Secondary outcomes (1)
  1. Change from baseline activity limitations

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

    Measured: 2 months after baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2014 (estimated)
  2. Study startApr 2014
  3. Primary completion16 Jan 2019
  4. Study completion28 Jan 2019

Resources

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
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
344 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02327377
Sponsor's protocol ID
140559
Status last verified
Mar 2019
First submitted
10 Dec 2014
Last updated
28 Mar 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

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

Questions about this trial

What is this clinical trial studying?

A study testing Online Cognitive Behavior Therapy and Online Education in people with Gastrointestinal Disorders, Functional, run by Vanderbilt University Medical Center 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 3 inclusion and 5 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 28 Mar 2019. 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?

Change from baseline somatic symptoms (time frame: 2 months after baseline). The study lists 2 primary outcomes in all. 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 NCT02327377, 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 28 Mar 2019.

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