Internet-Delivered Pain Self-Management to Reduce Pain and Interference in Chronic Pancreatitis

NIH RePORTER · NIH · R01 · $726,463 · view on reporter.nih.gov ↗

Abstract

Project Summary Severe abdominal pain is a cardinal symptom of pancreatitis, present in up to 90% of patients with recurrent acute pancreatitis (RAP) and chronic pancreatitis (CP). As pain increases in severity and constancy, it is 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. Painful RAP and CP is most often managed with chronic opioids, which unfortunately have limited efficacy and substantial risk for adverse side effects. This application focuses on addressing this treatment gap in pain management with a well-established nonpharmacologic intervention. Our team has established efficacy of an internet-delivered cognitive-behavioral therapy (CBT) intervention for chronic pain, and recently adapted it for pancreatitis pain (the Pancreatitis Pain Course), showing promise for reducing pain and disability in this population. We propose a hybrid effectiveness-implementation design type 1 trial to make rapid translational gains with the primary goal of gathering data on CBT treatment effects on pancreatitis pain and pain interference in individuals with RAP and CP with a secondary goal of gathering implementation data to inform dissemination of the Pancreatitis Pain Course to real-world settings. Our central hypothesis is that the Pancreatitis Pain Course will be effective in reducing pain interference and severity in individuals with painful RAP and CP. Our specific aims are to 1) Determine the effectiveness of the Pancreatitis Pain Course in improving pancreatitis pain outcomes, 2) (Exploratory) Explore the moderating effects of social determinants of health with changes in pain interference and severity following treatment, and 3) Identify implementation facilitators, challenges, and solutions for structures and processes that contribute to the seamless integration of the Pancreatitis Pain Course into clinical centers and the community. This study will leverage resources of the Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC) Consortium, a NIDDK-sponsored U01 consortium with recruitment from their nine clinical centers and from self-referral in the community through partnership with the National Pancreas Foundation. Using a multicenter randomized-controlled pragmatic clinical trial, we will enroll 280 individuals with painful CP into the clinical trial and randomize them to CBT, providing access to the Pancreatitis Pain Course to learn pain self-management skills (e.g., relaxation, activity pacing, goal setting) or education control (access to education website about RAP and CP pain). We will collect patient-reported outcomes at baseline, two months, and six-month follow-up. Relevant stakeholder groups (patients, providers, organizational managers) will participate in a process evaluation to inform future implementation in clinic and community settings. The proposed investigation will si...

Key facts

NIH application ID
10916518
Project number
5R01DK137520-02
Recipient
SEATTLE CHILDREN'S HOSPITAL
Principal Investigator
DARWIN LEWIS CONWELL
Activity code
R01
Funding institute
NIH
Fiscal year
2024
Award amount
$726,463
Award type
5
Project period
2023-09-01 → 2028-07-31