Internet Based Cognitive Behavioral Therapy in Pediatric Chronic Pancreatitis

NCT03707431 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-04-09

Study results available
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Summary

Abdominal pain is common in children with chronic and acute recurring pancreatitis (CP, ARP), and as they continue into adulthood, the disease progresses with increased pain and greater exposure to opioids. Despite the relevancy of early pain self-management for childhood pancreatitis, there have been no studies of non-pharmacological pain intervention in this population. The proposed project will evaluate a web-based cognitive behavioral pain management program delivered to a cohort of well-phenotyped children with CP/ARP and some community participants to reduce pain, pain-related disability and enhance HRQOL; it will also identify genetic risk factors and clinical and behavioral phenotypic factors associated with treatment response to enable precision medicine approaches.

Conditions

  • Chronic Pancreatitis
  • Acute Recurrent Pancreatitis

Interventions

BEHAVIORAL

Web-based CBT

The eight child modules include: 1) education about chronic pain, 2) recognizing stress and negative emotions, 3) deep breathing and relaxation, 4) implementing coping skills at school, 5) cognitive skills (e.g., reducing negative thoughts), 6) lifestyle interventions, 7) staying active (e.g., pleasant activity scheduling), 8) relapse prevention. The eight parent modules are: 1) education about chronic pain, 2) recognizing stress and negative emotions, 3) operant strategies I (using attention and praise to increase coping), 4) operant strategies II (using rewards to increase positive coping and reach school goals), 5) modeling, 6) lifestyle, 7) communication, 8) relapse prevention.

BEHAVIORAL

Pain Education

The pain education website provides publicly available educational information about pancreatitis and abdominal pain. There is general information about pancreatitis from available web sources (e.g., National Pancreas Foundation) as well as information about chronic pain in childhood. The content does not include any instruction in the behavioral and cognitive skills taught within the WebMAP program.

Sponsors & Collaborators

  • University of Iowa

    collaborator OTHER
  • University of Virginia

    collaborator OTHER
  • Washington University School of Medicine

    collaborator OTHER
  • M.D. Anderson Cancer Center

    collaborator OTHER
  • The University of Texas Health Science Center, Houston

    collaborator OTHER
  • Children's Hospital Medical Center, Cincinnati

    collaborator OTHER
  • Children's Hospital Los Angeles

    collaborator OTHER
  • Children's Hospital of Philadelphia

    collaborator OTHER
  • University of Toronto

    collaborator OTHER
  • McGill University Health Centre/Research Institute of the McGill University Health Centre

    collaborator OTHER
  • Medical College of Wisconsin

    collaborator OTHER
  • Massachusetts General Hospital

    collaborator OTHER
  • University of Minnesota

    collaborator OTHER
  • Ohio State University

    collaborator OTHER
  • University of Pittsburgh

    collaborator OTHER
  • University of California, San Francisco

    collaborator OTHER
  • University of Utah

    collaborator OTHER
  • Indiana University

    collaborator OTHER
  • Sydney Children's Hospitals Network

    collaborator OTHER
  • Cedars-Sinai Medical Center

    collaborator OTHER
  • Stanford University

    collaborator OTHER
  • Ariel Precision Medicine

    collaborator INDUSTRY
  • University of Texas Southwestern Medical Center

    collaborator OTHER
  • Seattle Children's Hospital

    lead OTHER

Principal Investigators

  • Tonya Palermo, PhD · Seattle Children's Hospital

  • Aliye Uc, MD · University of Iowa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-25
Primary Completion
2024-07-31
Completion
2024-07-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03707431 on ClinicalTrials.gov