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NCT03707431

Internet Based Cognitive Behavioral Therapy in Pediatric Chronic Pancreatitis

Completed NA Results posted Last updated 9 April 2026
What this trial tests

NA trial testing Web-based CBT in Chronic Pancreatitis in 90 participants. Completed in 31 July 2024.

Timeline
25 April 2019
Primary endpoint
31 July 2024
31 July 2024

Quick facts

Lead sponsorSeattle Children's Hospital
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment90
Start date25 April 2019
Primary completion31 July 2024
Estimated completion31 July 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Seattle Children's Hospital

Who can join

Adults 10 to 19, any sex, with Chronic Pancreatitis or Acute Recurrent Pancreatitis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Adolescent Abdominal Pain Severity Primary · 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.

T1 (Baseline)
GroupValue95% CI
Pain Education (WebED)2.11± 1.06
Web-based CBT (WebMAP)1.74± 1.61
T2 (Post-treatment, 12 weeks)
GroupValue95% CI
Pain Education (WebED)1.99± 1.22
Web-based CBT (WebMAP)1.61± 1.19
T3 (6-month follow-up)
GroupValue95% CI
Pain Education (WebED)1.62± 1.27
Web-based CBT (WebMAP)1.48± 1.19
Change in Pain-related Disability Secondary · 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.

T1 (Baseline)
GroupValue95% CI
Pain Education (WebED)22.03± 7.11
Web-based CBT (WebMAP)20.47± 6.18
T2 (Post-treatment, 12 weeks)
GroupValue95% CI
Pain Education (WebED)22.09± 9.96
Web-based CBT (WebMAP)18.95± 5.59
T3 (6-month Follow-up)
GroupValue95% CI
Pain Education (WebED)24.24± 8.57
Web-based CBT (WebMAP)16.48± 6.72
Change in Health-related Quality of Life Secondary · 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.

T1 Physical Health (Baseline)
GroupValue95% CI
Pain Education (WebED)59.59± 23.81
Web-based CBT (WebMAP)60.73± 24.57
T2 Physical Health (Post-treatment, 12 weeks)
GroupValue95% CI
Pain Education (WebED)62.27± 25.22
Web-based CBT (WebMAP)64.03± 24.38
T3 Physical Health (6-month follow-up)
GroupValue95% CI
Pain Education (WebED)64.10± 27.31
Web-based CBT (WebMAP)64.81± 22.38
T1 Psychosocial Health (Baseline)
GroupValue95% CI
Pain Education (WebED)62.27± 15.33
Web-based CBT (WebMAP)62.2± 21.06
T2 Psychosocial Health (Post-treatment, 12 weeks)
GroupValue95% CI
Pain Education (WebED)66.06± 19.94
Web-based CBT (WebMAP)65.58± 20.71
T3 Psychosocial Health (6-month follow-up)
GroupValue95% CI
Pain Education (WebED)70.69± 17.95
Web-based CBT (WebMAP)64.99± 18.37
Change in Emotional Distress Secondary · 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 deviati

T1 Depression (Baseline)
GroupValue95% CI
Pain Education (WebED)50.97± 9.78
Web-based CBT (WebMAP)50.53± 11.48
T2 Depression (Post-treatment, 12 weeks)
GroupValue95% CI
Pain Education (WebED)51.22± 10.54
Web-based CBT (WebMAP)50.20± 13.11
T3 Depression (6-month follow-up)
GroupValue95% CI
Pain Education (WebED)50.04± 10.69
Web-based CBT (WebMAP)51.10± 12.12
T1 Anxiety (Baseline)
GroupValue95% CI
Pain Education (WebED)51.07± 10.44
Web-based CBT (WebMAP)10.19± 10.06
T2 Anxiety (Post-treatment, 12 weeks)
GroupValue95% CI
Pain Education (WebED)51.06± 12.38
Web-based CBT (WebMAP)48.68± 11.56
T3 Anxiety (6-month follow-up)
GroupValue95% CI
Pain Education (WebED)48.95± 10.19
Web-based CBT (WebMAP)50.26± 11.12
Change in Opioid Use Secondary · Baseline, 6 months

Over the counter and prescription (opioid and non-opioid) medication use in the preceding 7 days.

T1 (Baseline)
GroupValue95% CI
Pain Education (WebED)9
Web-based CBT (WebMAP)6
Pain Education (WebED)35
Web-based CBT (WebMAP)40
T3 (6-month follow-up)
GroupValue95% CI
Pain Education (WebED)7
Web-based CBT (WebMAP)4
Pain Education (WebED)37
Web-based CBT (WebMAP)40
Change in Pain Self-efficacy Secondary · 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.

T1 (Baseline)
GroupValue95% CI
Pain Education (WebED)21.76± 6.19
Web-based CBT (WebMAP)22.72± 6.07
T2 (Post-treatment, 12 weeks)
GroupValue95% CI
Pain Education (WebED)19.78± 6.85
Web-based CBT (WebMAP)21.11± 7.06
T3 (6-month follow-up)
GroupValue95% CI
Pain Education (WebED)20.37± 8
Web-based CBT (WebMAP)20.3± 5.64
Change in Parent Impact of Pain Secondary · 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 reliabi

T1 Depression (Baseline)
GroupValue95% CI
Pain Education (WebED)13.67± 6.17
Web-based CBT (WebMAP)13.57± 5.84
T2 Depression (Post-treatment, 12 weeks)
GroupValue95% CI
Pain Education (WebED)13.31± 6.13
Web-based CBT (WebMAP)12.01± 6.73
T3 Depression (6-month follow-up)
GroupValue95% CI
Pain Education (WebED)12.21± 5.28
Web-based CBT (WebMAP)12.37± 6.48
T1 Anxiety (Baseline)
GroupValue95% CI
Pain Education (WebED)11.60± 5.03
Web-based CBT (WebMAP)10.31± 5.70
T2 Anxiety (Post-treatment, 12 weeks)
GroupValue95% CI
Pain Education (WebED)10.19± 4.75
Web-based CBT (WebMAP)9.12± 6.17
T3 Anxiety (6-month follow-up)
GroupValue95% CI
Pain Education (WebED)9.28± 5.14
Web-based CBT (WebMAP)9.81± 5.75
Change in Pain Interference Secondary · 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.

T1 (Baseline)
GroupValue95% CI
Pain Education (WebED)56.44± 11.17
Web-based CBT (WebMAP)55.83± 12.01
T2 (Post-treatment, 12 weeks)
GroupValue95% CI
Pain Education (WebED)56.65± 11.00
Web-based CBT (WebMAP)53.21± 13.28
T3 (6-month follow-up)
GroupValue95% CI
Pain Education (WebED)53.3± 12.84
Web-based CBT (WebMAP)55.69± 10.71
Change in Health Service Utilization Secondary · 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 cost

T1 Emergency Visits (Baseline)
GroupValue95% CI
Pain Education (WebED)1.98± 1.92
Web-based CBT (WebMAP)2.73± 4.05
T3 Emergency Visits (6-month follow-up)
GroupValue95% CI
Pain Education (WebED)1.62± 1.95
Web-based CBT (WebMAP)1.72± 2.15
T1 Outpatient Dr Visits (Baseline)
GroupValue95% CI
Pain Education (WebED)4.71± 3.24
Web-based CBT (WebMAP)4.27± 3.01
T3 Outpatient Dr Visits (6-month follow-up)
GroupValue95% CI
Pain Education (WebED)4.55± 3.03
Web-based CBT (WebMAP)4.35± 3.69

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. 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).
    Palermo TM, Murray C, Aalfs H, Abu-El-Haija M, et al · · 2020 · cited 17× · PMID 31756383 · DOI 10.1016/j.cct.2019.105898

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