Internet-Delivered Pain Self-Management for Persons With Acute Recurrent and Chronic Pancreatitis Pain (IMPACT-2)

July 15, 2026 updated by: Tonya Palermo, Seattle Children's Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
280

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98105
        • Recruiting
        • Seattle Children's Hospital
        • Contact:
        • Principal Investigator:
          • Tonya M Palermo, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: 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)
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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in pain severity and pain interference
Time Frame: Baseline, 2-month follow-up, 6-month follow-up
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in disease-specific pain
Time Frame: Baseline, 2-month follow-up, 6-month follow-up
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.
Baseline, 2-month follow-up, 6-month follow-up
Change in physical functioning
Time Frame: Baseline, 2-month follow-up, 6-month follow-up
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.
Baseline, 2-month follow-up, 6-month follow-up
Change in psychological functioning
Time Frame: Baseline, 2-month follow-up, 6-month follow-up
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.
Baseline, 2-month follow-up, 6-month follow-up
Change in pain catastrophizing
Time Frame: Baseline, 2-month follow-up, 6-month follow-up
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.
Baseline, 2-month follow-up, 6-month follow-up
Change in sleep disturbance
Time Frame: Baseline, 2-month follow-up, 6-month follow-up
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.
Baseline, 2-month follow-up, 6-month follow-up
Change in disease specific health-related quality of life
Time Frame: Baseline, 2-month follow-up, 6-month follow-up
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.
Baseline, 2-month follow-up, 6-month follow-up
Change in patient global impression of change
Time Frame: 2-month follow-up, 6-month follow-up
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).
2-month follow-up, 6-month follow-up
Change in opioid use
Time Frame: Baseline, 2-month follow-up, 6-month follow-up
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.
Baseline, 2-month follow-up, 6-month follow-up
Treatment acceptability
Time Frame: 2-month follow-up
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".
2-month follow-up
Change in substance use
Time Frame: Baseline, 6-month follow-up
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.
Baseline, 6-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seattle Children's Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Kentucky

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 23, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 26, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1R01DK137520-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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