Internet Based Cognitive Behavioral Therapy in Pediatric Chronic Pancreatitis
NCT03707431 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90
Last updated 2026-04-09
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 - collaborator OTHER
-
Ohio State University
collaborator OTHER -
University of Pittsburgh
collaborator OTHER -
University of California, San Francisco
collaborator OTHER - collaborator OTHER
-
Indiana University
collaborator OTHER -
Sydney Children's Hospitals Network
collaborator OTHER -
Cedars-Sinai Medical Center
collaborator OTHER - 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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