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Behavioral Intervention

Online Pain Management for Chronic Pancreatitis (IMPACT-2 Trial)

N/A

Recruiting

Research Sponsored by Seattle Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

Currently experiencing suicidal ideation

Having received endoscopic therapy in the past 30 days

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2-month follow-up, 6-month follow-up

Summary

This trial aims to help people with chronic pancreatitis who suffer from severe abdominal pain. The study will use an online program to teach self-management techniques to reduce pain and improve quality of life. The goal

Who is the study for?

This trial is for people with severe and disabling abdominal pain due to chronic or acute pancreatitis. Participants should have access to the internet as the program is delivered online.

What is being tested?

The study tests an internet-delivered pain self-management program based on cognitive-behavioral therapy (CBT) against a standard educational program, aiming to reduce pain and improve life quality.

What are the potential side effects?

Since this trial involves non-medical interventions like CBT and education programs, there are no direct physical side effects; however, emotional discomfort may arise from discussing painful experiences.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My diagnosis is chronic pancreatitis with clear signs on scans.

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I have had abdominal pain for 3 months or more, or I've had acute pancreatitis.

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I am 18 years old or older.

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I have had moderate pain (4 or higher on a scale of 0-10) from my condition in the last month.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently having thoughts about harming myself.

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I have undergone endoscopic therapy within the last month.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2-month follow-up, 6-month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2-month follow-up, 6-month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2-month follow-up, 6-month follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in pain severity and pain interference

Secondary study objectives

Change in disease specific health-related quality of life

Change in disease-specific pain

Change in opioid use

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Internet-delivered pain self-management (CBT Condition)Experimental Treatment1 Intervention

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.

Group II: Education ProgramPlacebo Group1 Intervention

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.

0 / 6Eligibility criteria met