Recruiting

Pain Self-Management

Sponsor:

Seattle Children's Hospital

Code:

NCT06386224

Conditions

Pancreatitis

Chronic Pancreatitis

Acute Recurrent Pancreatitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Internet-delivered pain self-management (CBT Condition)

Education Program

Study Details

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

Chronic Pancreatitis

Acute Recurrent Pancreatitis

Study ID

NCT06386224

Start date

May 1, 2024

Status verified date

Jul, 2026

Completion date

Jul 1, 2028

Anticipated

Primary completion date

Jul 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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)

Study Design

Enrollment

280 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Internet-delivered pain self-management (CBT Condition)

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.

placebo comparator: Education Program

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.

Interventions

Internet-delivered pain self-management (CBT Condition)

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)

Education Program

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.

Primary outcome measure

  • Change in pain severity and pain interference [ Time Frame: Baseline, 2-month follow-up, 6-month follow-up ]

Central Contacts and Locations

Central contacts

Tonya Palermo, PhD

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

Locations

Seattle Children's Hospital

Recruiting

Seattle, Washington, United States, 98105

Contacts

Tonya Palermo, PhD

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

Principal Investigator:

Tonya M Palermo, PhD

More Information

Sponsor

Seattle Children's Hospital

Last update posted

Jul 17, 2026

Last verified

Jul, 2026

Keywords

  • Pancreatitis
  • Pain
  • Internet Intervention
  • Behavioral Intervention
  • Cognitive Behavioral Therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Seattle Children's Hospital on 2026-07-17.