Internet Based Cognitive Behavioral Therapy in Pediatric Chronic Pancreatitis

  • STATUS
    Recruiting
  • End date
    May 31, 2024
  • participants needed
    260
  • sponsor
    Seattle Children's Hospital
Updated on 29 May 2022
analgesics
abdominal pain

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.

Description

Abdominal pain is present in 81% of children and adolescents with CP and ARP. Effective treatments that target pain in these children will lessen the risk of opioid exposure and continued pain and disability into adulthood. We plan to recruit a large multicenter sample of 260 children and adolescents (ages 10-19 years) with CP/ARP and their parents from INSPPIRE 2 (INSPPIRE:INternational Study Group of Pediatric Pancreatitis: In search for a cuRE) centers and pancreatitis community groups (e.g. NPF) to evaluate the efficacy of WebMAP, a web-based cognitive behavioral pain management program (CBT). The study design is a two (group) x three (time point) randomized, controlled, double-blinded trial. Participants will be randomly assigned to receive online access to either pain education (WebED) or CBT (WebMAP) over an 8-10 week treatment period. The primary study outcome is abdominal pain symptoms measured at pre-treatment, immediately post-treatment, and at 6-month follow-up. Secondary outcomes include pain-related disability, health-related quality of life, depression and anxiety symptoms, and medication use. This project represents a significant advance in pain management for children with CP/ARP by evaluating the first ever nonpharmacologic pain intervention in these patients, which may guide future developments in the management of chronic pain associated with CP/ARP.

Details
Condition Chronic Pancreatitis, Acute Recurrent Pancreatitis
Treatment Pain education, Web-based CBT
Clinical Study IdentifierNCT03707431
SponsorSeattle Children's Hospital
Last Modified on29 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosed with CP or ARP
ages 10-19 years
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
access to the Internet on any web-enabled device

Exclusion Criteria

non-English speaking
inability to read at the 5th grade level due to learning problem or developmental delay
children with cystic fibrosis who have pancreatic insufficiency at the time of diagnosis
patients with Shwachman-Bodian-Diamond Syndrome
Acute Recurrent Pancreatitis (ARP) with no evidence of chronic or persistent pain
anticipated surgery (TPIAT or other) during study participation
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