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Internet Based Cognitive Behavioral Therapy in Pediatric Chronic Pancreatitis

Primary Purpose

Chronic Pancreatitis, Acute Recurrent Pancreatitis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Web-based CBT
Pain Education
Sponsored by
Seattle Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pancreatitis focused on measuring Adolescent, Pancreatitis, Pain, Internet Intervention, Behavioral Intervention

Eligibility Criteria

10 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seattle Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Web-based CBT (WebMAP)

Pain Education (WebED)

Arm Description

Receives access to WebMAP

Receives access to WebED

Outcomes

Primary Outcome Measures

Change in 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.

Secondary Outcome Measures

Change in pain-related disability
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.
Change in health-related quality of life
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.
Change in emotional distress
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.
Change in opioid use
Youth and parents will report on over the counter and prescription (opioid and non-opioid) medication use in the preceding 7 days.
Change in pain self-efficacy
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.
Change in parent impact of pain
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.
Change in pain interference
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.
Change in health service utilization
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.

Full Information

First Posted
October 2, 2018
Last Updated
July 17, 2023
Sponsor
Seattle Children's Hospital
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, 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
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1. Study Identification

Unique Protocol Identification Number
NCT03707431
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 25, 2019 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seattle Children's Hospital
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, 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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pancreatitis, Acute Recurrent Pancreatitis
Keywords
Adolescent, Pancreatitis, Pain, Internet Intervention, Behavioral Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized and double-blinded controlled trial of web-based CBT (WebMAP) vs pain education (WebED).
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
260 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Web-based CBT (WebMAP)
Arm Type
Experimental
Arm Description
Receives access to WebMAP
Arm Title
Pain Education (WebED)
Arm Type
Active Comparator
Arm Description
Receives access to WebED
Intervention Type
Behavioral
Intervention Name(s)
Web-based CBT
Other Intervention Name(s)
WebMAP
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Pain Education
Other Intervention Name(s)
WebED
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in abdominal pain severity
Description
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.
Time Frame
Baseline, 12 weeks, 6 months
Secondary Outcome Measure Information:
Title
Change in pain-related disability
Description
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.
Time Frame
Baseline, 12 weeks, 6 months
Title
Change in health-related quality of life
Description
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.
Time Frame
Baseline, 12 weeks, 6 months
Title
Change in emotional distress
Description
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.
Time Frame
Baseline, 12 weeks, 6 months
Title
Change in opioid use
Description
Youth and parents will report on over the counter and prescription (opioid and non-opioid) medication use in the preceding 7 days.
Time Frame
Baseline, 12 weeks, 6 months
Title
Change in pain self-efficacy
Description
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.
Time Frame
Baseline, 12 weeks, 6 months
Title
Change in parent impact of pain
Description
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.
Time Frame
Baseline, 12 weeks, 6 months
Title
Change in pain interference
Description
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.
Time Frame
Baseline, 12 weeks, 6 months
Title
Change in health service utilization
Description
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.
Time Frame
Baseline, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tonya Palermo, PhD
Phone
206-884-4208
Email
tonya.palermo@seattlechildrens.org
First Name & Middle Initial & Last Name or Official Title & Degree
Homer Aalfs, BS
Phone
206-884-1845
Email
homer.aalfs@seattlechildrens.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tonya Palermo, PhD
Organizational Affiliation
Seattle Children's Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Aliye Uc, MD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tonya M Palermo, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
31756383
Citation
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.
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Internet Based Cognitive Behavioral Therapy in Pediatric Chronic Pancreatitis

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