Internet Based Cognitive Behavioral Therapy in Pediatric Chronic Pancreatitis

Seattle Children's Healthcare System

Status: Completed

Conditions: Chronic Pancreatitis; Acute Recurrent Pancreatitis

Treatments: Behavioral: Pain Education; Behavioral: Web-based CBT

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03707431

1R01DK118752-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 10 to 19 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosed with CP or ARP
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

1. non-English speaking
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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups

Web-based CBT (WebMAP)

Experimental group

Description:

Receives access to WebMAP

Treatment:

Behavioral: Web-based CBT

Pain Education (WebED)

Active Comparator group

Description:

Receives access to WebED

Treatment:

Behavioral: Pain Education