Internet Based Cognitive Behavioral Therapy in Pediatric Chronic Pancreatitis

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Brief Title

Internet Based Cognitive Behavioral Therapy in Pediatric Chronic Pancreatitis

Official Title

A Randomized Trial of a Web-based Non-pharmacological Pain Intervention for Pediatric Chronic Pancreatitis

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.
    

Detailed Description

      Abdominal pain is present in 81% of children and adolescents with CP and ARP. Effective
      treatments that target pain in these children will lessen the risk of opioid exposure and
      continued pain and disability into adulthood. We plan to recruit a large multicenter sample
      of 260 children and adolescents (ages 10-19 years) with CP/ARP and their parents from
      INSPPIRE 2 (INSPPIRE:INternational Study Group of Pediatric Pancreatitis: In search for a
      cuRE) centers and pancreatitis community groups (e.g. NPF) to evaluate the efficacy of
      WebMAP, a web-based cognitive behavioral pain management program (CBT). The study design is a
      two (group) x three (time point) randomized, controlled, double-blinded trial. Participants
      will be randomly assigned to receive online access to either pain education (WebED) or CBT
      (WebMAP) over an 8-10 week treatment period. The primary study outcome is abdominal pain
      symptoms measured at pre-treatment, immediately post-treatment, and at 6-month follow-up.
      Secondary outcomes include pain-related disability, health-related quality of life,
      depression and anxiety symptoms, and medication use. This project represents a significant
      advance in pain management for children with CP/ARP by evaluating the first ever
      nonpharmacologic pain intervention in these patients, which may guide future developments in
      the management of chronic pain associated with CP/ARP.
    


Study Type

Interventional


Primary Outcome

Change in abdominal pain severity

Secondary Outcome

 Change in pain-related disability

Condition

Chronic Pancreatitis

Intervention

Web-based CBT

Study Arms / Comparison Groups

 Web-based CBT (WebMAP)
Description:  Receives access to WebMAP

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

260

Start Date

April 25, 2019

Completion Date

May 31, 2023

Primary Completion Date

January 31, 2023

Eligibility Criteria

        Inclusion Criteria:

          1. Diagnosed with CP or ARP

          2. ages 10-19 years

          3. 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

          4. access to the Internet on any web-enabled device

        Exclusion criteria:

          1. non-English speaking

          2. inability to read at the 5th grade level due to learning problem or developmental
             delay

          3. children with cystic fibrosis who have pancreatic insufficiency at the time of
             diagnosis

          4. patients with Shwachman-Bodian-Diamond Syndrome

          5. Acute Recurrent Pancreatitis (ARP) with no evidence of chronic or persistent pain

          6. anticipated surgery (TPIAT or other) during study participation
      

Gender

All

Ages

10 Years - 19 Years

Accepts Healthy Volunteers

No

Contacts

Tonya Palermo, PhD, 206-884-4208, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03707431

Organization ID

1R01DK118752-01


Responsible Party

Principal Investigator

Study Sponsor

Seattle Children's Hospital

Collaborators

 University of Iowa

Study Sponsor

Tonya Palermo, PhD, Principal Investigator, Seattle Children's Research Institute


Verification Date

December 2020