PancreatitisIMPACT-2NCT06386224
Internet-Delivered Pain Self-Management for Persons With Acute Recurrent and Chronic Pancreatitis Pain
A study testing Internet-delivered pain self-management (CBT Condition) and Education Program in people with Pancreatitis and Chronic Pancreatitis, run by Seattle Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatitis, Chronic Pancreatitis, Acute Recurrent Pancreatitis
- What is being tested?
- Internet-delivered pain self-management (CBT Condition) and Education Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 280 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2024to 1 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Seattle Children's Hospital
Seattle, Washington, 98105
Tonya Palermo, PhD, 206-884-4208, tonya.palermo@seattlechildrens.org
Tonya M Palermo, PhD
About this study
Official title: 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.
Read the 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.
- Being tested
- Internet-delivered pain self-management (CBT Condition), Education Program
- Keywords
- Pancreatitis, Pain, Internet Intervention, Behavioral Intervention, Cognitive Behavioral Therapy
- Medical subject headings
- Pancreatitis, Pancreatitis, Chronic, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-delivered pain self-management (CBT Condition)Behavioural
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 ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Education Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 2-month follow-up, 6-month follow-up
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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".
Measured: 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.
Measured: Baseline, 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start1 May 2024
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kentucky
- Responsible party
- Principal investigator, Tonya Palermo, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06386224
- Sponsor's protocol ID
- 1R01DK137520-01
- Acronym
- IMPACT-2
- Status last verified
- Jul 2026
- First submitted
- 23 Apr 2024
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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;27(1):204. doi: 10.1186/s13063-026-09517-6.
PubMed 41664170
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-Delivered Pain Self-Management to Reduce Pain and Interference in Chronic Pancreatitis
- ClinicalTrials.gov ID
- NCT06386224
- Acronym / sponsor ID
- IMPACT-2 / 1R01DK137520-01
- Keywords
- Pancreatitis, Pain, Internet Intervention, Behavioral Intervention, Cognitive Behavioral Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Collaborators
- University of Kentucky
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 26 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Internet-delivered pain self-management (CBT Condition) | Experimental | Behavioral: 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. |
| Education Program | Placebo comparator | Behavioral: Education ProgramParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Behavioural | Internet-delivered pain self-management (CBT Condition) |
| Education ProgramParticipants 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. | Behavioural | Education Program |
Primary outcome
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.
10 secondary outcomes
Change in disease-specific pain
Time frame: Baseline, 2-month follow-up, 6-month follow-up
Change in physical functioning
Time frame: Baseline, 2-month follow-up, 6-month follow-up
Change in psychological functioning
Time frame: Baseline, 2-month follow-up, 6-month follow-up
Change in pain catastrophizing
Time frame: Baseline, 2-month follow-up, 6-month follow-up
Change in sleep disturbance
Time frame: 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
Change in patient global impression of change
Time frame: 2-month follow-up, 6-month follow-up
Change in opioid use
Time frame: Baseline, 2-month follow-up, 6-month follow-up
Treatment acceptability
Time frame: 2-month follow-up
Change in substance use
Time frame: Baseline, 6-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Derived from this study: PubMed 41664170Palermo 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;27(1):204. doi: 10.1186/s13063-026-09517-6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-delivered pain self-management (CBT Condition) and Education Program in people with Pancreatitis and Chronic Pancreatitis, run by Seattle Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tonya Palermo, PhD (206-884-4208, tonya.palermo@seattlechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain severity and pain interference (time frame: Baseline, 2-month follow-up, 6-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06386224, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.