Internet-Delivered Pain Self-Management for Persons With Acute Recurrent and Chronic Pancreatitis Pain

NCT06386224 | Recruiting

• 1 other identifier: 1R01DK137520-01
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreatitis; Acute Recurrent Pancreatitis; Chronic Pancreatitis

Keywords

Pancreatitis; Pain; Internet Intervention; Behavioral Intervention; Cognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 2-month follow-up, 6-month follow-up

Secondary Outcomes (10)

• Change in disease-specific pain

  Baseline, 2-month follow-up, 6-month follow-up

• Change in physical functioning

  Baseline, 2-month follow-up, 6-month follow-up

• Change in psychological functioning

  Baseline, 2-month follow-up, 6-month follow-up

• Change in pain catastrophizing

  Baseline, 2-month follow-up, 6-month follow-up

• Change in sleep disturbance

  Baseline, 2-month follow-up, 6-month follow-up

Study Arms (2)

Internet-delivered pain self-management (CBT Condition)

EXPERIMENTAL

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)

Education Program

PLACEBO COMPARATOR

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

Interventions

Internet-delivered pain self-management (CBT Condition) BEHAVIORAL

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)

Internet-delivered pain self-management (CBT Condition)

Education Program BEHAVIORAL

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.

Education Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Willingness to use personal device with internet access (smart phone, computer, iPad) or to borrow a study iPad/hotspot
• Diagnosis of CP defined as having obvious morphological features of CP (i.e., Cambridge 3-4 stage or the presence of pancreatic calcifications on CT scan and/or magnetic resonance cholangiopancreatography)
• Diagnosis of RAP defined as having abdominal pain of a duration of \>=3 months, one episode of acute pancreatitis (AP), or RAP.
• Having experienced moderate pain intensity (rated as 4 or higher on a 0-10 Numerical Rating Scale) in the last month from RAP or CP.

You may not qualify if:

• Undergoing treatment for cancer
• Unable to read English well enough to complete questionnaires or read the study website
• Currently experiencing suicidal ideation
• Having received endoscopic therapy in the past 30 days
• Currently receiving treatment from a psychologist (\> 4 sessions)

Sponsors & Collaborators

• Seattle Children's Hospital: lead
• University of Kentucky: collaborator

Study Sites (1)

Seattle Children's Hospital

Seattle, Washington, 98105, United States

RECRUITING

Related Publications (1)

• Palermo TM, Ohls O, Dear B, Doorenbos AZ, Yadav D, Zhou C, Bellin M, Fisher W, Fogel E, Forsmark C, Hart PA, Park WG, Pandol S, Trikudanathan G, Conwell DL. 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. Trials. 2026 Feb 9. doi: 10.1186/s13063-026-09517-6. Online ahead of print.

  PMID: 41664170 DERIVED

MeSH Terms

Conditions

Pancreatitis; Pancreatitis, Chronic; Pain

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Central Study Contacts

Tonya Palermo, PhD

CONTACT

206-884-4208; tonya.palermo@seattlechildrens.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants are not informed of their condition assignment and both receive online programs for chronic pancreatitis. Investigators are blinded \& masked to study condition, and all outcomes are assessed via self-reported REDCap surveys. Care providers are not involved in the study (N/A).
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Anesthesiology and Pain Medicine

Model Details: Participants randomized to the active intervention arm will receive access to the Pancreatitis Pain Course to learn cognitive-behavioral (CBT) pain self-management skills (e.g., changing negative thoughts, relaxation, activity pacing, goal setting). Participants randomized to the control arm will receive access to an education website.

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: April 26, 2024
• Study Start: May 1, 2024
• Primary Completion: March 31, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)