Internet Based Cognitive Behavioral Therapy in Pediatric Chronic Pancreatitis
NCT ID: NCT03707431
Last Updated: 2024-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
90 participants
INTERVENTIONAL
2019-04-25
2024-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Web-based CBT (WebMAP)
Receives access to WebMAP
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.
Pain Education (WebED)
Receives access to WebED
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. ages 10-19 years
3. at least 4 acute pancreatitis flare-ups/attacks in past year, or at least 1 instance of moderate (4/10 pain) pancreatitis/abdominal pain in the past month
4. access to the Internet on any web-enabled device
Exclusion Criteria
2. inability to read at the 5th grade level due to learning problem or developmental delay
3. children with cystic fibrosis who have pancreatic insufficiency at the time of diagnosis
4. patients with Shwachman-Bodian-Diamond Syndrome
5. Acute Recurrent Pancreatitis (ARP) with no evidence of chronic or persistent pain
6. anticipated surgery (TPIAT or other) during study participation
10 Years
19 Years
ALL
No
Sponsors
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University of Iowa
OTHER
University of Virginia
OTHER
Washington University School of Medicine
OTHER
M.D. Anderson Cancer Center
OTHER
The University of Texas Health Science Center, Houston
OTHER
Children's Hospital Medical Center, Cincinnati
OTHER
Children's Hospital Los Angeles
OTHER
Children's Hospital of Philadelphia
OTHER
University of Toronto
OTHER
McGill University Health Centre/Research Institute of the McGill University Health Centre
OTHER
Medical College of Wisconsin
OTHER
Massachusetts General Hospital
OTHER
University of Minnesota
OTHER
Ohio State University
OTHER
University of Pittsburgh
OTHER
University of California, San Francisco
OTHER
University of Utah
OTHER
Indiana University
OTHER
Sydney Children's Hospitals Network
OTHER
Cedars-Sinai Medical Center
OTHER
Stanford University
OTHER
Ariel Precision Medicine
INDUSTRY
University of Texas Southwestern Medical Center
OTHER
Seattle Children's Hospital
OTHER
Responsible Party
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Tonya Palermo
Professor, Anesthesiology and Pain Medicine
Principal Investigators
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Tonya Palermo, PhD
Role: PRINCIPAL_INVESTIGATOR
Seattle Children's Hospital
Aliye Uc, MD
Role: PRINCIPAL_INVESTIGATOR
University of Iowa
Locations
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Seattle Children's Hospital
Seattle, Washington, United States
Countries
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References
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Palermo TM, Murray C, Aalfs H, Abu-El-Haija M, Barth B, Bellin MD, Ellery K, Fishman DS, Gariepy CE, Giefer MJ, Goday P, Gonska T, Heyman MB, Husain SZ, Lin TK, Liu QY, Mascarenhas MR, Maqbool A, McFerron B, Morinville VD, Nathan JD, Ooi CY, Perito ER, Pohl JF, Schwarzenberg SJ, Sellers ZM, Serrano J, Shah U, Troendle D, Zheng Y, Yuan Y, Lowe M, Uc A; Consortium for the Study of Chronic Pancreatitis, Diabetes and Pancreatic Cancer. Web-based cognitive-behavioral intervention for pain in pediatric acute recurrent and chronic pancreatitis: Protocol of a multicenter randomized controlled trial from the study of chronic pancreatitis, diabetes and pancreatic cancer (CPDPC). Contemp Clin Trials. 2020 Jan;88:105898. doi: 10.1016/j.cct.2019.105898. Epub 2019 Nov 19.
Other Identifiers
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