Digital cognitive-behavioral therapy for pain management in individuals with recurrent acute and chronic pancreatitis (IMPACT-2): study protocol for a hybrid effectiveness-implementation trial

Background: Abdominal pain is a cardinal symptom of pancreatitis, present in up to 90% of patients with recurrent acute pancreatitis (RAP) and chronic pancreatitis (CP). Increases in pain severity and constancy are associated with significant morbidity including depression and anxiety symptoms, low physical functioning, sleep disturbance, and low quality of life, as well as high economic and societal burden. Our pilot study of digital cognitive-behavioral therapy (CBT) demonstrated preliminary efficacy in improving pain and disability in adults with recurrent acute and chronic pancreatitis pain. Building on these promising findings, this hybrid effectiveness-implementation clinical trial seeks to test the effectiveness of digital CBT in a large sample and to gather data on future implementation of this scalable intervention. Methods: This multisite, pragmatic clinical trial is recruiting 280 adults (ages 18 +) with recurrent acute or chronic pancreatitis who report chronic pain. Participants are randomized 1:1 respectively to one of two groups: (1) Digital CBT, providing access to the Pancreatitis Pain Course to learn pain self-management skills (e.g., relaxation, activity pacing, goal setting), or (2) Digital Pain Education (access to education website about pancreatitis pain). Evaluations are completed at baseline, 2 months, and 6 months follow up. This study leverages resources of the Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC), a NIH-sponsored U01 consortium, with recruitment from their nine clinical centers and from self-referral in the community through partnerships with community-based and clinical organizations. Relevant stakeholder groups (patients, providers, organizational managers) will participate in a process evaluation to inform future implementation in clinic and community settings. Primary effectiveness outcomes are pain interference and severity. Secondary outcomes include opioid use, depression, anxiety, quality of life, and sleep. Discussion: Findings from the IMPACT-2 trial will significantly advance solutions for non-pharmacological pain management in RAP and CP. If successful, our project will address a critical need for low-cost, accessible pain self-management. Trial registration: NCT06386224; first posted: 04–26–2024.