Internet Based Cognitive Behavioral Therapy in Pediatric Chronic Pancreatitis

NCT03707431 | Completed Results DMC

• 1 other identifier: 1R01DK118752-01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Abdominal pain is common in children with chronic and acute recurring pancreatitis (CP, ARP), and as they continue into adulthood, the disease progresses with increased pain and greater exposure to opioids. Despite the relevancy of early pain self-management for childhood pancreatitis, there have been no studies of non-pharmacological pain intervention in this population. The proposed project will evaluate a web-based cognitive behavioral pain management program delivered to a cohort of well-phenotyped children with CP/ARP and some community participants to reduce pain, pain-related disability and enhance HRQOL; it will also identify genetic risk factors and clinical and behavioral phenotypic factors associated with treatment response to enable precision medicine approaches.

Conditions

Chronic Pancreatitis; Acute Recurrent Pancreatitis

Keywords

Adolescent; Pancreatitis; Pain; Internet Intervention; Behavioral Intervention

Outcome Measures

Primary Outcomes (1)

• Change in Adolescent Abdominal Pain Severity

  The Abdominal Pain Index (API) assesses characteristics of abdominal pain during the previous 2 weeks including the number of days with pain, number of pain episodes per day, typical pain episode duration, and typical pain intensity. An index is computed with higher scores indicating greater abdominal pain severity. A mean score is reported on a scale of 0 to 4, where higher values indicate more severe (worse) abdominal pain severity.

  Baseline, 12 weeks, 6 months

Secondary Outcomes (8)

• Change in Pain-related Disability

  Baseline, 12 weeks, 6 months

• Change in Health-related Quality of Life

  Baseline, 12 weeks, 6 months

• Change in Emotional Distress

  Baseline, 12 weeks, 6 months

• Change in Opioid Use

  Baseline, 6 months

• Change in Pain Self-efficacy

  Baseline, 12 weeks, 6 months

Study Arms (2)

Web-based CBT (WebMAP)

EXPERIMENTAL

Receives access to WebMAP

Behavioral: Web-based CBT

Pain Education (WebED)

ACTIVE COMPARATOR

Receives access to WebED

Behavioral: Pain Education

Interventions

Web-based CBT BEHAVIORAL

The eight child modules include: 1) education about chronic pain, 2) recognizing stress and negative emotions, 3) deep breathing and relaxation, 4) implementing coping skills at school, 5) cognitive skills (e.g., reducing negative thoughts), 6) lifestyle interventions, 7) staying active (e.g., pleasant activity scheduling), 8) relapse prevention. The eight parent modules are: 1) education about chronic pain, 2) recognizing stress and negative emotions, 3) operant strategies I (using attention and praise to increase coping), 4) operant strategies II (using rewards to increase positive coping and reach school goals), 5) modeling, 6) lifestyle, 7) communication, 8) relapse prevention.

Also known as: WebMAP

Web-based CBT (WebMAP)

Pain Education BEHAVIORAL

The pain education website provides publicly available educational information about pancreatitis and abdominal pain. There is general information about pancreatitis from available web sources (e.g., National Pancreas Foundation) as well as information about chronic pain in childhood. The content does not include any instruction in the behavioral and cognitive skills taught within the WebMAP program.

Also known as: WebED

Pain Education (WebED)

Eligibility Criteria

• Age: 10 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosed with CP or ARP
• ages 10-19 years
• at least 4 acute pancreatitis flare-ups/attacks in past year, or at least 1 instance of moderate (4/10 pain) pancreatitis/abdominal pain in the past month
• access to the Internet on any web-enabled device

You may not qualify if:

• non-English speaking
• inability to read at the 5th grade level due to learning problem or developmental delay
• children with cystic fibrosis who have pancreatic insufficiency at the time of diagnosis
• patients with Shwachman-Bodian-Diamond Syndrome
• Acute Recurrent Pancreatitis (ARP) with no evidence of chronic or persistent pain
• anticipated surgery (TPIAT or other) during study participation

Sponsors & Collaborators

• Seattle Children's Hospital: lead
• University of Iowa: collaborator
• University of Virginia: collaborator
• Washington University School of Medicine: collaborator
• M.D. Anderson Cancer Center: collaborator
• The University of Texas Health Science Center, Houston: collaborator
• Children's Hospital Medical Center, Cincinnati: collaborator
• Children's Hospital Los Angeles: collaborator
• Children's Hospital of Philadelphia: collaborator
• University of Toronto: collaborator
• McGill University Health Centre/Research Institute of the McGill University Health Centre: collaborator
• Medical College of Wisconsin: collaborator
• Massachusetts General Hospital: collaborator
• University of Minnesota: collaborator
• Ohio State University: collaborator
• University of Pittsburgh: collaborator
• University of California, San Francisco: collaborator
• University of Utah: collaborator
• Indiana University: collaborator
• Sydney Children's Hospitals Network: collaborator
• Cedars-Sinai Medical Center: collaborator
• Stanford University: collaborator
• Ariel Precision Medicine: collaborator
• University of Texas Southwestern Medical Center: collaborator

Study Sites (1)

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Related Publications (1)

• Palermo TM, Murray C, Aalfs H, Abu-El-Haija M, Barth B, Bellin MD, Ellery K, Fishman DS, Gariepy CE, Giefer MJ, Goday P, Gonska T, Heyman MB, Husain SZ, Lin TK, Liu QY, Mascarenhas MR, Maqbool A, McFerron B, Morinville VD, Nathan JD, Ooi CY, Perito ER, Pohl JF, Schwarzenberg SJ, Sellers ZM, Serrano J, Shah U, Troendle D, Zheng Y, Yuan Y, Lowe M, Uc A; Consortium for the Study of Chronic Pancreatitis, Diabetes and Pancreatic Cancer. Web-based cognitive-behavioral intervention for pain in pediatric acute recurrent and chronic pancreatitis: Protocol of a multicenter randomized controlled trial from the study of chronic pancreatitis, diabetes and pancreatic cancer (CPDPC). Contemp Clin Trials. 2020 Jan;88:105898. doi: 10.1016/j.cct.2019.105898. Epub 2019 Nov 19.

  PMID: 31756383 BACKGROUND

MeSH Terms

Conditions

Pancreatitis, Chronic; Pancreatitis; Pain

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Limitations and Caveats

We relied on a self-reported diagnosis of ARP or CP for adolescents from the community, which may be inaccurate, and could have impacted our ability to distinguish between diagnostic groups. In addition, we did not reach our enrollment goal due to the COVID-19 pandemic's impact on clinic visits and a lower frequency of pain complaints than anticipated, causing many participants to be ineligible. This made it less likely we would statistically detect a small or moderate effect ("underpowered").

Results Point of Contact

• Title: Tonya Palermo
• Organization: Seattle Children's Research Institute

tonya.palermo@seattlechildrens.org

2068840000

Study Officials

• Tonya Palermo, PhD

  Seattle Children's Hospital

  PRINCIPAL INVESTIGATOR

• Aliye Uc, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Anesthesiology and Pain Medicine

Model Details: Randomized and double-blinded controlled trial of web-based CBT (WebMAP) vs pain education (WebED).

Study Record Dates

• First Submitted: October 2, 2018
• First Posted: October 16, 2018
• Study Start: April 25, 2019
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: April 9, 2026
• Results First Posted: April 9, 2026

Record last verified: 2026-03

Locations

US (1)