Online Pain Management for Chronic Pancreatitis

(IMPACT-2 Trial)

Overseen By Tonya Palermo, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Seattle Children's Hospital

Disqualifiers: Cancer, Suicidal ideation, others

Compensation: Varies

Number of Visits: 7

Duration: 8 weeks

280 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help people with chronic pancreatitis (a long-term inflammation of the pancreas) manage severe abdominal pain through an online program. The program teaches pain management skills via five online lessons based on cognitive-behavioral therapy, which focuses on changing thought patterns. Participants will either use this Internet-delivered pain self-management program (CBT Condition) or receive educational content about pancreatitis. Individuals who have experienced moderate abdominal pain for at least three months, have internet access, and can use an online device might be a good fit. As an unphased trial, this study offers a unique opportunity to contribute to innovative pain management strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on an online pain management program, so it's best to discuss your medications with the trial coordinators.

What prior data suggests that this internet-delivered pain self-management program is safe for individuals with chronic pancreatitis?

Research has shown that online cognitive-behavioral therapy (CBT) is safe and well-tolerated for managing chronic pain. Studies have found moderate to large improvements in pain levels and the impact of pain on daily life within three months of starting treatment. No major negative effects have been reported, making this method a promising option for managing chronic pain without medication. The online format also allows easy access, which can be especially helpful for people with mobility issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the internet-delivered pain self-management program for chronic pancreatitis because it offers a new way to manage pain using cognitive-behavioral therapy (CBT) techniques online. Unlike traditional pain management options, which often rely on medications or in-person therapy sessions, this program allows participants to access pain management resources from any internet-enabled device. It provides structured, interactive lessons that teach individuals cognitive and behavioral skills to manage their pain, which can be completed at their own pace over eight weeks. This innovative approach not only increases accessibility but also empowers patients with chronic pancreatitis to take an active role in their pain management.

What evidence suggests that this internet-delivered pain self-management program is effective for chronic pancreatitis pain?

Research has shown that online cognitive-behavioral therapy (CBT) can significantly help people manage chronic pain. In studies with patients experiencing long-term pain, those using online CBT reported noticeable reductions in both pain intensity and its impact on daily activities. In this trial, participants randomized to the Internet-delivered pain self-management (CBT Condition) will receive a program designed to manage chronic pancreatitis pain. Early results suggest this method holds promise for individuals with chronic pancreatitis pain. Participants have learned to manage their pain better through the skills and strategies taught in these online programs. This approach helps individuals use techniques to lessen pain's impact, leading to a better quality of life. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

Willingness to use personal device with internet access (smart phone, computer, iPad) or to borrow a study iPad/hotspot

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

Exclusion Criteria

Unable to read English well enough to complete questionnaires or read the study website

I am currently having thoughts about harming myself.

I am currently receiving treatment for cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive internet-delivered pain self-management or education program over eight weeks

8 weeks

5 online lessons

Follow-up

Participants are monitored for changes in pain severity, interference, and other outcomes

6 months

Assessments at baseline, 2-month, and 6-month follow-up

What Are the Treatments Tested in This Trial?

Interventions

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

Trial Overview

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.

How Is the Trial Designed?

Group I: Internet-delivered pain self-management (CBT Condition) Experimental Treatment 1 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 Program Placebo Group 1 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.

Who Is Running the Clinical Trial?

Seattle Children's Hospital

Lead Sponsor

Trials

319

Recruited

5,232,000+

University of Kentucky

Collaborator

Trials

198

Recruited

224,000+

Published Research Related to This Trial

The Internet-delivered cognitive behavioral pain management course, known as the Pain Course, showed significant effectiveness in reducing disability, depression, and anxiety among 55 participants, with improvements maintained at a 3-month follow-up.

The program was highly acceptable, with a 76% completion rate and 85% of participants recommending it, indicating that it is a feasible option for managing chronic pain in a publicly funded online therapy setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness, acceptability and feasibility of an Internet-delivered cognitive behavioral pain management program in a routine online therapy clinic in Canada. Hadjistavropoulos, HD., Schneider, LH., Hadjistavropoulos, T., et al.[2022]

A randomized non-inferiority trial is being conducted with 230 patients suffering from chronic low back pain to compare the effectiveness of traditional in-person cognitive behavioral therapy (CBT) with an innovative interactive voice response (IVR)-based CBT, aiming to enhance access to treatment.

The primary goal is to assess pain intensity immediately after treatment, while secondary outcomes will evaluate pain-related interference, emotional functioning, and quality of life over time, potentially demonstrating that IVR-based CBT can effectively provide care to more patients without compromising treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cooperative pain education and self-management (COPES): study design and protocol of a randomized non-inferiority trial of an interactive voice response-based self-management intervention for chronic low back pain. Heapy, AA., Higgins, DM., LaChappelle, KM., et al.[2022]

Adding telephone support to the Reboot Online pain management program significantly improved participant enrollment (93% vs. 78%) and commencement rates (91% vs. 60%) compared to the program without support, indicating that clinician guidance can enhance initial engagement.

Despite the increased engagement, the overall completion rates and clinical effectiveness of the program were similar between the two groups, suggesting that while support helps get participants started, it may not influence their ability to finish the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Adjunct Telephone Support on Adherence and Outcomes of the Reboot Online Pain Management Program: Randomized Controlled Trial. Gardner, T., Schultz, R., Haskelberg, H., et al.[2022]

Web-based cognitive behavioral therapy (CBT) effectively reduced pain interference and intensity in patients with chronic musculoskeletal pain, regardless of whether they received additional phone-based support from nurses.

The study found no significant differences in pain-related outcomes between the group receiving nurse support and the control group, except for a slight improvement in sleep disturbance favoring the nurse support group, suggesting that web-based CBT alone may be a cost-effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nurse-Supported Web-Based Cognitive Behavioral Therapy for Chronic Musculoskeletal Pain: A Randomized Controlled Trial. Diab, R., Bomar, R., Slaven, J., et al.[2023]

Internet-delivered psychological therapies significantly reduced pain and disability in adults with chronic pain, particularly for those with non-headache conditions, showing moderate to small effect sizes post-treatment.

However, there was no clear evidence that these therapies improved depression or anxiety, and the overall efficacy for headache conditions remains uncertain, highlighting the need for further research and exploration of patient satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological therapies (Internet-delivered) for the management of chronic pain in adults. Eccleston, C., Fisher, E., Craig, L., et al.[2022]

The COPES trial demonstrated that interactive voice response-based cognitive behavioral therapy (IVR-CBT) is as effective as in-person CBT for managing chronic back pain, with similar reductions in pain intensity after 3 months.

IVR-CBT also showed lower dropout rates, suggesting it may be a more accessible and convenient option for patients, enhancing their ability to engage in treatment compared to traditional in-person therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interactive Voice Response-Based Self-management for Chronic Back Pain: The COPES Noninferiority Randomized Trial. Heapy, AA., Higgins, DM., Goulet, JL., et al.[2019]

A 4-week smartphone intervention following an inpatient chronic pain rehabilitation program showed modest long-term benefits in reducing catastrophizing and increasing acceptance of pain among participants, despite no significant differences between groups at the 11-month follow-up.

While the intervention group experienced improvements in their pain-related thoughts and acceptance, the control group showed negative effects in functioning and emotional distress, highlighting the potential value of ongoing support through digital interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A smartphone-based intervention with diaries and therapist feedback to reduce catastrophizing and increase functioning in women with chronic widespread pain. part 2: 11-month follow-up results of a randomized trial. Kristjánsdóttir, ÓB., Fors, EA., Eide, E., et al.[2021]

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