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.

Abstract

Introduction: Abdominal pain is common and is associated with high disease burden and health care costs in pediatric acute recurrent and chronic pancreatitis (ARP/CP). Despite the strong central component of pain in ARP/CP and the efficacy of psychological therapies for other centralized pain syndromes, no studies have evaluated psychological pain interventions in children with ARP/CP. The current trial seeks to 1) evaluate the efficacy of a psychological pain intervention for pediatric ARP/CP, and 2) examine baseline patient-specific genetic, clinical, and psychosocial characteristics that may predict or moderate treatment response.

Methods: This single-blinded randomized placebo-controlled multicenter trial aims to enroll 260 youth (ages 10-18) with ARP/CP and their parents from twenty-one INSPPIRE (INternational Study Group of Pediatric Pancreatitis: In search for a cuRE) centers. Participants will be randomly assigned to either a web-based cognitive behavioral pain management intervention (Web-based Management of Adolescent Pain Chronic Pancreatitis; WebMAP; N = 130) or to a web-based pain education program (WebED; N = 130). Assessments will be completed at baseline (T1), immediately after completion of the intervention (T2) and at 6 months post-intervention (T3). The primary study outcome is abdominal pain severity. Secondary outcomes include pain-related disability, pain interference, health-related quality of life, emotional distress, impact of pain, opioid use, and healthcare utilization.

Conclusions: This is the first clinical trial to evaluate the efficacy of a psychological pain intervention for children with CP for reduction of abdominal pain and improvement of health-related quality of life. Findings will inform delivery of web-based pain management and potentially identify patient-specific biological and psychosocial factors associated with favorable response to therapy. Clinical Trial Registration #: NCT03707431.

Keywords: Acute recurrent pancreatitis; Children; Chronic pancreatitis; Cognitive-behavioral therapy; Internet intervention; Pain.

Publication types

  • Clinical Trial Protocol
  • Research Support, N.I.H., Extramural

MeSH terms

  • Abdominal Pain / etiology
  • Abdominal Pain / therapy*
  • Adolescent
  • Analgesics, Opioid / therapeutic use
  • Child
  • Cognitive Behavioral Therapy / methods*
  • Humans
  • Internet-Based Intervention*
  • Multicenter Studies as Topic
  • Pain Management / methods*
  • Pain Measurement
  • Pancreatitis / complications
  • Pancreatitis / physiopathology*
  • Pancreatitis, Chronic / complications
  • Pancreatitis, Chronic / physiopathology*
  • Quality of Life
  • Randomized Controlled Trials as Topic
  • Recurrence

Substances

  • Analgesics, Opioid

Associated data

  • ClinicalTrials.gov/NCT03707431