An interventional study of Internet-delivered pain self-management (CBT Condition) and Education Program in Pancreatitis, Chronic Pancreatitis and Acute Recurrent Pancreatitis, sponsored by Seattle Children's Hospital. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-17.
Sponsored by Seattle Children's Hospital · Not applicable, Interventional, and Supportive care
Severe and disabling abdominal pain is common in individuals with chronic pancreatitis. Although pain is associated with reduced quality of life and high economic and societal costs, there are limited effective options for pain management in this population. This study proposes an evidence-based psychological intervention approach using an internet-delivered pain self-management program to minimize the impact of pain and improve quality of life. The ultimate goal is to maximize the public health impact of the intervention with successful implementation and dissemination to pancreas clinics and to the community.
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. This application focuses on addressing this treatment gap in pain management with a well-established nonpharmacologic intervention. The investigators propose a hybrid effectiveness-implementation design type 1 trial to make rapid translational gains with the primary goal of gathering data on treatment effects of internet-delivered pain self-management 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 program to real-world settings. Our central hypothesis is that pain self-management will be effective in reducing pain interference and severity in individuals with painful RAP and CP. This study will leverage resources of the Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC) Consortium, a National Institute of Diabetes and Digestive and Kidney Diseases-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, the study team will enroll 280 individuals with painful CP into the clinical trial and randomize them to learn pain self-management skills (e.g., relaxation, activity pacing, goal setting) or receive education, and 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 significantly advance solutions for nonopioid pain management in CP.
264 studies on the registry are indexed under Pancreatitis, Chronic; 76 are open to participants now.
This study's planned enrollment of 280 is above the median of 45 across 143 interventional studies indexed under Pancreatitis, Chronic.
Browse Pancreatitis, Chronic studies →Seattle Children's Hospital is the lead sponsor of 215 studies on the registry; 44 are open to participants now.
Compared within Pancreatitis, Chronic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Pancreatitis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
Participants randomized to the CBT condition will receive access to a pain self-management program, available through any internet-enabled device. The design and treatment content follow a cognitive-behavioral framework in which participants receive information to understand their CP pain, learn a range of cognitive and behavioral skills to manage their symptoms and difficulties, and practice and adopt the skills taught in the program. The program consists of 5 online lessons, which are in the form of a slide show, and 5 downloadable lesson summaries, which provide homework assignments to assist participants in learning and applying the skills described in the lessons. These materials are released over the course of eight weeks and include a combination of didactic information and narrative examples. Several detailed case stories and real-world examples of individuals with CP pain are integrated throughout the course.
Behavioral: Internet-delivered pain self-management (CBT Condition)
Participants randomized to the education program will receive access to a website with information about pancreatitis pain from publicly available educational websites (e.g., National Pancreas Foundation). Participants assigned to the education program will complete five modules released over the same time interval as the CBT group.
Behavioral: Education Program
Participants will login to the website for 15-20 minutes per week, and complete 5 modules focused on different skills delivered over 8 weeks (e.g., symptom identification, changing negative thoughts, activity pacing)
Participants will login to the website for 15-20 minutes per week, and complete 5 modules focusing on pancreatitis pain topics, including: an introduction to pancreatitis, treatment options, specific therapies, surgical procedures.
Change in pain severity and pain interference
The Brief Pain Inventory Short Form (BPI) assesses pain intensity and pain interference in a 24-hour time frame. Participants will complete prospective monitoring for seven days at each assessment. Four pain intensity items evaluate worst, least, average, and current pain intensity and 7 pain intensity items evaluate pain interference with sleep, mood, walking ability, general physical activity, work, relationships, and enjoyment of life.
Time frame: Baseline, 2-month follow-up, 6-month follow-up
Change in disease-specific pain
The Comprehensive Pain Assessment Tool for Chronic Pancreatitis (COMPAT) is a modified 5-item measure assessing 5 pancreatitis specific pain dimensions (patterns, severity, provocation, spreading, descriptive) and an overall score.
Time frame: Baseline, 2-month follow-up, 6-month follow-up
Change in physical functioning
The Patient Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Short Form 6b is a modified five-item measure assessing impairment in physical functioning. Responses are rated on a 5-point scale (1-5) with higher scores indicating greater perceived difficulty with activities.
Time frame: Baseline, 2-month follow-up, 6-month follow-up
Change in psychological functioning
Depressive symptoms will be assessed with the Patient Health Questionnaire (PHQ-9). Anxiety symptoms will be assessed with the Generalized Anxiety Disorder Assessment (GAD-7). Items are scored on a 0-3 scale where 0 = Not at all, 1 = Several Days, 2 = More than half the days and 3 = Nearly every day. Clinical cutoffs are available on both scales to determine clinical severity.
Time frame: Baseline, 2-month follow-up, 6-month follow-up
Change in pain catastrophizing
The Pain Catastrophizing Scale - Short Form 6 will be used to assess magnification of, rumination about, and hopelessness regarding pain. Items are rated on a 5-point scale (0 = Not at all, 5 = All the time) and summed to create a total score.
Time frame: Baseline, 2-month follow-up, 6-month follow-up
Change in sleep disturbance
The PROMIS Sleep Disturbance 6a is a six-item measure of sleep quality and disturbance. Items are scored on a 5-point Likert scale ranging from 1 = Very good, to 5 = Very poor. T scores are computed with a population mean of 50 and standard deviation of 10.
Time frame: Baseline, 2-month follow-up, 6-month follow-up
Change in disease specific health-related quality of life
Disease-specific health-related quality of life (HRQL) will be assessed using the Pancreatitis Quality of Life Instrument (PANQOLI) which includes 18 items that map onto five subscales and a total HRQL score.
Time frame: Baseline, 2-month follow-up, 6-month follow-up
Change in patient global impression of change
Participants will respond to the following, single-item question, "Since the start of the study my overall status is . . ." using a 7-point rating scale (1 = very much improved, 7 = very much worse).
Time frame: 2-month follow-up, 6-month follow-up
Change in opioid use
Participants will report medication use on the BPI from a drop down list (e.g., opioid, acetaminophen, other) indicating doses. Number of days of opioid use on the BPI over seven days will be used for analysis.
Time frame: Baseline, 2-month follow-up, 6-month follow-up
Treatment acceptability
A treatment acceptability and satisfaction measure, the Treatment Evaluation Inventory will be administered at posttreatment. Scores above 27 indicate that patients perceive the treatment to be at least "moderately acceptable".
Time frame: 2-month follow-up
Change in substance use
Tobacco, Alcohol, Prescription Medication, and Other Substance Use Tool (TAPS) consists of a four-item screen for the use of tobacco, alcohol, and illicit drugs, and the nonmedical use of prescription drugs, followed by a substance-specific assessment of risk level for individuals who screen positive. These data will be used to characterize the extent of substance-use comorbidity in the sample.
Time frame: Baseline, 6-month follow-up
Plan to share: No
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