Internet Based Cognitive Behavioral Therapy in Pediatric Chronic Pancreatitis

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03707431

Enrollment

Registered

2018-10-16

Start date

2019-04-25

Completion date

2024-07-31

Last updated

2026-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Recurrent Pancreatitis, Chronic Pancreatitis

Keywords

Adolescent, Pancreatitis, Pain, Internet Intervention, Behavioral Intervention

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.

Interventions

BEHAVIORALWeb-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.

BEHAVIORALPain Education

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

10 Years to 19 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Change in Adolescent Abdominal Pain Severity	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. A mean score is reported on a scale of 0 to 4, where higher values indicate more severe (worse) abdominal pain severity.

Secondary

Measure	Time frame	Description
Change in Pain-related Disability	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. The maximum possible total score is 36.
Change in Health-related Quality of Life	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. All scales range from 0 to 100.
Change in Emotional Distress	Baseline, 12 weeks, 6 months	The Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Emotional Distress Scales include an 8-item scale of anxiety (Pediatric v2.0 SF8a Anxiety) that assesses fear (e.g., fearfulness), anxious misery (e.g., worry) and hyperarousal (e.g., nervousness) and 8-item scale of depressive symptoms (Pediatric v2.0 SF8a 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 (worse) symptoms. The general population mean T-score is 50, with a standard deviation of 10. Anxiety T-scores range from 33.5-83.3, and depression T-scores range from 35.2-82.4.
Change in Opioid Use	Baseline, 6 months	Over the counter and prescription (opioid and non-opioid) medication use in the preceding 7 days.
Change in Pain Self-efficacy	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 (score range 7-35) indicate higher self-efficacy.
Change in Parent Impact of Pain	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 (leisure) 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 (worse) 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. For brevity given the number of time points and subscales, the depression (range: 0-36) and anxiety (range: 0-24) subscales are reported here.
Change in Pain Interference	Baseline, 12 weeks, 6 months	The PROMIS Pain Interference - v2.0 Pediatric Short Form 8a 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 (worse) symptoms. T-scores range from 34-78. The general population mean T-score is 50, with a standard deviation of 10.
Change in Health Service Utilization	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. For brevity, we will report the 2 primary variables used in analysis found to be related to child pain: the number of doctor outpatient service visits and number of emergency dept visits.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORTonya Palermo, PhD

Seattle Children's Hospital

PRINCIPAL_INVESTIGATORAliye Uc, MD

University of Iowa

Participant flow

Recruitment details

We enrolled 90 adolescents (ages 10-19, 63% female) with ARP or CP and their parents or caregivers into this randomized placebo-controlled multicenter trial from 15 INSPPIRE (INternational Study Group of Pediatric Pancreatitis: In search for a cuRE) centers or from the community. The number of participants refers to dyads (parents and adolescents). Enrollment, randomization and progression through the study was by dyad.

Baseline characteristics

Characteristic	—
Adolescent Pancreatitis Diagnosis Type Acute Recurrent Pancreatitis (ARP)	23 Participants
Adolescent Pancreatitis Diagnosis Type Chronic Pancreatitis (CP)	22 Participants
Adolescent Pancreatitis Diagnosis Type Unknown	2 Participants
Age, Continuous	15.16 age (years) STANDARD_DEVIATION 2.31
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	34 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	5 Participants
Race (NIH/OMB) Black or African American	2 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants
Race (NIH/OMB) White	67 Participants
Recruitment Source Community	10 Participants
Recruitment Source INSPPIRE2	66 Participants
Sex: Female, Male Female	23 Participants
Sex: Female, Male Male	20 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	0 / 44	0 / 46	0 / 44	0 / 46
other Total, other adverse events	0 / 44	0 / 46	0 / 44	0 / 46
serious Total, serious adverse events	0 / 44	0 / 46	0 / 44	0 / 46

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 10, 2026