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Internet Based Cognitive Behavioral Therapy in Pediatric Chronic Pancreatitis

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ClinicalTrials.gov Identifier: NCT03707431
Recruitment Status : Recruiting
First Posted : October 16, 2018
Last Update Posted : July 30, 2019
Sponsor:
Collaborators:
University of Iowa
University of Virginia
Washington University School of Medicine
M.D. Anderson Cancer Center
The University of Texas Health Science Center, Houston
Children's Hospital Medical Center, Cincinnati
Children's Hospital Los Angeles
Children's Hospital of Philadelphia
University of Toronto
McGill University Health Centre/Research Institute of the McGill University Health Centre
Medical College of Wisconsin
Massachusetts General Hospital
University of Minnesota - Clinical and Translational Science Institute
Ohio State University
University of Pittsburgh
University of California, San Francisco
University of Utah
Indiana University
Sydney Children's Hospitals Network
Cedars-Sinai Medical Center
Stanford University
Ariel Precision Medicine
University of Texas Southwestern Medical Center
Information provided by (Responsible Party):
Tonya Palermo, Seattle Children's Hospital

Brief Summary:
Abdominal pain is common in children with chronic pancreatitis (CP), 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 CP, 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 to reduce pain, pain-related disability and enhance HRQOL and will identify genetic risk factors and clinical and behavioral phenotypic factors associated with treatment response to enable precision medicine approaches.

Condition or disease Intervention/treatment Phase
Chronic Pancreatitis Behavioral: Web-based CBT Behavioral: Pain Education Not Applicable

Detailed Description:
Abdominal pain is present in 81% of children and adolescents with chronic pancreatitis (CP). 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 10-17 years) with CP and their parents from INSPPIRE 2 (INSPPIRE:INternational Study Group of Pediatric Pancreatitis: In search for a cuRE) centers 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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized and double-blinded controlled trial of web-based CBT (WebMAP) vs pain education (WebED).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Trial of a Web-based Non-pharmacological Pain Intervention for Pediatric Chronic Pancreatitis
Actual Study Start Date : April 25, 2019
Estimated Primary Completion Date : January 31, 2023
Estimated Study Completion Date : May 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Web-based CBT (WebMAP)
Receives access to WebMAP
Behavioral: Web-based CBT
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.
Other Name: WebMAP

Active Comparator: Pain Education (WebED)
Receives access to WebED
Behavioral: Pain Education
The pain education website provides publically available educational information about chronic 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.
Other Name: WebED




Primary Outcome Measures :
  1. Change in abdominal pain severity [ Time Frame: Baseline, 12 weeks, 6 months ]
    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.


Secondary Outcome Measures :
  1. Change in pain-related disability [ Time Frame: Baseline, 12 weeks, 6 months ]
    The Child Activity Limitations Interview (CALI-9) is a daily diary validated to assess perceived difficulty in completing 9 daily activities as a measure of pain-related disability. Responses are rated on a 5-point scale (0-4) with higher scores indicating greater perceived difficulty with activities. Youth will provide ratings daily for 7 days on their online diaries at each assessment period. Mean total activity limitations across the reporting period is used in analyses, with higher scores indicating greater disability.

  2. Change in health-related quality of life [ Time Frame: Baseline, 12 weeks, 6 months ]
    The Pediatric Quality of Life Inventory (Peds-QL) assesses several domains of functioning, including physical, social, emotional, and academic functioning. The PedsQL is widely used as it demonstrates good reliability for both the parent and child self-report measures. Higher scores indicate fewer difficulties (better) health-related quality of life. Sub scales of physical and psychosocial health will be used in analyses.

  3. Change in emotional distress [ Time Frame: Baseline, 12 weeks, 6 months ]
    The Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Emotional Distress Scales include an 8-item scale of anxiety that assesses fear (e.g., fearfulness), anxious misery (e.g., worry) and hyperarousal (e.g., nervousness) and 8-item scale of depressive symptoms that evaluates negative mood, view of self and social cognitions. Raw scores and T-scores are computed with T-scores above 60 indicating clinically elevated symptoms.

  4. Change in opioid use [ Time Frame: Baseline, 12 weeks, 6 months ]
    Youth and parents will report on over the counter and prescription (opioid and non-opioid) medication use in the preceding 7 days.

  5. Change in pain self-efficacy [ Time Frame: Baseline, 12 weeks, 6 months ]
    The Pain Self-Efficacy Scale is a 7-item measure that assesses the child's beliefs in carrying out activities when in pain. The scale has demonstrated good internal consistency, cross-informant reliability with parent report, and strong construct validity. Higher scores indicate higher self-efficacy.

  6. Change in parent impact of pain [ Time Frame: Baseline, 12 weeks, 6 months ]
    Parents will complete the Bath Adolescent Pain Questionnaire-Parent Impact Questionnaire (BAPQ-PIQ), a measure of the impact of parenting an adolescent with chronic pain. The BAPQ-PIQ is a 62-item questionnaire with 8 scales including: depressive symptoms, anxiety, pain catastrophizing, self-blame, partner relationship, social functioning, parental behavior, and parental role strain. Items are rated on a 5-point frequency response scale (0 = never, 4 = always) with higher scores indicating more impaired functioning for all subscales. The BAPQ-PIQ has demonstrated good reliability and validity among parents of youth with chronic pain. Sub scales will be analyzed separately.

  7. Change in pain interference [ Time Frame: Baseline, 12 weeks, 6 months ]
    The PROMIS Pain Interference - Pediatric Short Form includes 8 items to assess consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. The scale has been validated in pediatric patients with chronic pain. Raw scores and T-scores are computed with T-scores above 60 indicating clinically elevated symptoms.

  8. Change in health service utilization [ Time Frame: Baseline, 6 months ]

    Parents will complete the Client Service Receipt Inventory-Pain version, a measure of service use, out-of-pocket expenses, and lost work time incurred by families for the evaluation or management of the child's chronic pain. Questions pertain to hospital admissions, outpatient services, community services (e.g., tutor, lawyer), medications, lost work time, paid help, and other costs. We will compute the following variables: total number of services used by category, number of lost parental work days, and number of out-of-pocket expenses.

    visits, medications, other treatments, and indirect costs as reported by the parent.




Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. CP is diagnosed in the presence of: (1) typical abdominal pain plus characteristic imaging findings; or (2) exocrine pancreatic insufficiency plus imaging findings; or (3) diabetes plus imaging findings
  2. ages 10-17 years
  3. pain duration > 3 months and pain frequency > once/week
  4. average pain rating ≥ 5 on two items from the Brief Pain Inventory asking about average pain intensity in the past week (0-10 scale) and activity interference due to pain (0-10 scale)
  5. 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 or developmental delay
  3. only 1 attack of acute pancreatitis (AP)
  4. diagnoses of AP based on levels of amylase or lipase ≤ 3 times greater than upper limits of normal without characteristic findings on imaging
  5. children with cystic fibrosis who have pancreatic insufficiency at the time of diagnosis
  6. patients with Shwachman-Bodian-Diamond Syndrome
  7. Acute Recurrent Pancreatitis (ARP) with no evidence of chronic or persistent pain

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03707431


Contacts
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Contact: Tonya Palermo, PhD 206-987-2518 tonya.palermo@seattlechildrens.org
Contact: Homer Aalfs, BS 206-884-1845 homer.aalfs@seattlechildrens.org

Locations
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United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Principal Investigator: Tonya M Palermo, PhD         
Sponsors and Collaborators
Seattle Children's Hospital
University of Iowa
University of Virginia
Washington University School of Medicine
M.D. Anderson Cancer Center
The University of Texas Health Science Center, Houston
Children's Hospital Medical Center, Cincinnati
Children's Hospital Los Angeles
Children's Hospital of Philadelphia
University of Toronto
McGill University Health Centre/Research Institute of the McGill University Health Centre
Medical College of Wisconsin
Massachusetts General Hospital
University of Minnesota - Clinical and Translational Science Institute
Ohio State University
University of Pittsburgh
University of California, San Francisco
University of Utah
Indiana University
Sydney Children's Hospitals Network
Cedars-Sinai Medical Center
Stanford University
Ariel Precision Medicine
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: Tonya Palermo, PhD Seattle Children's Research Institute
Principal Investigator: Aliye Uc, MD University of Iowa

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Responsible Party: Tonya Palermo, Professor, Anesthesiology and Pain Medicine, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT03707431     History of Changes
Other Study ID Numbers: 1R01DK118752-01 ( U.S. NIH Grant/Contract )
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tonya Palermo, Seattle Children's Hospital:
Adolescent
Pancreatitis
Pain
Internet Intervention
Behavioral Intervention
Additional relevant MeSH terms:
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Pancreatitis
Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases