Pancreatic Cancer Research

Clinical trialNACompleted

Internet Based Cognitive Behavioral Therapy in Pediatric Chronic Pancreatitis

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

Outcome
Outcome unknown
Phase
NA
Status
Completed
Study type
Interventional
Start
25 April 2019
Expected end
31 July 2024
Enrollment
90 participants
Sites
1
Primary outcomes
Change in Adolescent Abdominal Pain Severity
Sponsor
Other
Results posted
2026-04-09
Last update
9 April 2026

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Brief summary public domain (ClinicalTrials.gov)

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 public domain (ClinicalTrials.gov)

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.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Change in Adolescent Abdominal Pain Severity [Baseline, 12 weeks, 6 months]. Mean, scores on a scale (Standard Deviation). T1 (Baseline): Pain Education (WebED) (n=44): 2.11 (1.06); Web-based CBT (WebMAP) (n=46): 1.74 (1.61). T2 (Post-treatment, 12 weeks): Pain Education (WebED) (n=44): 1.99 (1.22); Web-based CBT (WebMAP) (n=46): 1.61 (1.19). T3 (6-month follow-up): Pain Education (WebED) (n=44): 1.62 (1.27); Web-based CBT (WebMAP) (n=46): 1.48 (1.19).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Change in Pain-related Disability [Baseline, 12 weeks, 6 months]. Mean, CALI total score (7-day average) (Standard Deviation). T1 (Baseline): Pain Education (WebED) (n=44): 22.03 (7.11); Web-based CBT (WebMAP) (n=46): 20.47 (6.18). T2 (Post-treatment, 12 weeks): Pain Education (WebED) (n=44): 22.09 (9.96); Web-based CBT (WebMAP) (n=46): 18.95 (5.59). T3 (6-month Follow-up): Pain Education (WebED) (n=44): 24.24 (8.57); Web-based CBT (WebMAP) (n=46): 16.48 (6.72).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Change in Health-related Quality of Life [Baseline, 12 weeks, 6 months]. Mean, Scores on a scale (Standard Deviation). T1 Physical Health (Baseline): Pain Education (WebED) (n=44): 59.59 (23.81); Web-based CBT (WebMAP) (n=46): 60.73 (24.57). T2 Physical Health (Post-treatment, 12 weeks): Pain Education (WebED) (n=44): 62.27 (25.22); Web-based CBT (WebMAP) (n=46): 64.03 (24.38). T3 Physical Health (6-month follow-up): Pain Education (WebED) (n=44): 64.10 (27.31); Web-based CBT (WebMAP) (n=46): 64.81 (22.38). T1 Psychosocial Health (Baseline): Pain Education (WebED) (n=44): 62.27 (15.33); Web-based CBT (WebMAP) (n=46): 62.2 (21.06). T2 Psychosocial Health (Post-treatment, 12 weeks): Pain Education (WebED) (n=44): 66.06 (19.94); Web-based CBT (WebMAP) (n=46): 65.58 (20.71). T3 Psychosocial Health (6-month follow-up): Pain Education (WebED) (n=44): 70.69 (17.95); Web-based CBT (WebMAP) (n=46): 64.99 (18.37).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Change in Emotional Distress [Baseline, 12 weeks, 6 months]. Mean, T-score (Standard Deviation). T1 Depression (Baseline): Pain Education (WebED) (n=44): 50.97 (9.78); Web-based CBT (WebMAP) (n=46): 50.53 (11.48). T2 Depression (Post-treatment, 12 weeks): Pain Education (WebED) (n=44): 51.22 (10.54); Web-based CBT (WebMAP) (n=46): 50.20 (13.11). T3 Depression (6-month follow-up): Pain Education (WebED) (n=44): 50.04 (10.69); Web-based CBT (WebMAP) (n=46): 51.10 (12.12). T1 Anxiety (Baseline): Pain Education (WebED) (n=44): 51.07 (10.44); Web-based CBT (WebMAP) (n=46): 10.19 (10.06). T2 Anxiety (Post-treatment, 12 weeks): Pain Education (WebED) (n=44): 51.06 (12.38); Web-based CBT (WebMAP) (n=46): 48.68 (11.56). T3 Anxiety (6-month follow-up): Pain Education (WebED) (n=44): 48.95 (10.19); Web-based CBT (WebMAP) (n=46): 50.26 (11.12).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Change in Opioid Use [Baseline, 6 months]. Count Of Participants, Participants. T1 (Baseline) / Using opioid medication: Pain Education (WebED) (n=44): 9; Web-based CBT (WebMAP) (n=46): 6. T1 (Baseline) / Not using opioid medication: Pain Education (WebED) (n=44): 35; Web-based CBT (WebMAP) (n=46): 40. T3 (6-month follow-up) / Using opioid medication: Pain Education (WebED) (n=44): 7; Web-based CBT (WebMAP) (n=46): 4. T3 (6-month follow-up) / Not using opioid medication: Pain Education (WebED) (n=44): 37; Web-based CBT (WebMAP) (n=46): 40.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Change in Pain Self-efficacy [Baseline, 12 weeks, 6 months]. Mean, scores on a scale (Standard Deviation). T1 (Baseline): Pain Education (WebED) (n=44): 21.76 (6.19); Web-based CBT (WebMAP) (n=46): 22.72 (6.07). T2 (Post-treatment, 12 weeks): Pain Education (WebED) (n=44): 19.78 (6.85); Web-based CBT (WebMAP) (n=46): 21.11 (7.06). T3 (6-month follow-up): Pain Education (WebED) (n=44): 20.37 (8); Web-based CBT (WebMAP) (n=46): 20.3 (5.64).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Change in Parent Impact of Pain [Baseline, 12 weeks, 6 months]. Mean, scores on a scale (Standard Deviation). T1 Depression (Baseline): Pain Education (WebED) (n=44): 13.67 (6.17); Web-based CBT (WebMAP) (n=46): 13.57 (5.84). T2 Depression (Post-treatment, 12 weeks): Pain Education (WebED) (n=44): 13.31 (6.13); Web-based CBT (WebMAP) (n=46): 12.01 (6.73). T3 Depression (6-month follow-up): Pain Education (WebED) (n=44): 12.21 (5.28); Web-based CBT (WebMAP) (n=46): 12.37 (6.48). T1 Anxiety (Baseline): Pain Education (WebED) (n=44): 11.60 (5.03); Web-based CBT (WebMAP) (n=46): 10.31 (5.70). T2 Anxiety (Post-treatment, 12 weeks): Pain Education (WebED) (n=44): 10.19 (4.75); Web-based CBT (WebMAP) (n=46): 9.12 (6.17). T3 Anxiety (6-month follow-up): Pain Education (WebED) (n=44): 9.28 (5.14); Web-based CBT (WebMAP) (n=46): 9.81 (5.75).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Change in Pain Interference [Baseline, 12 weeks, 6 months]. Mean, T Score (Standard Deviation). T1 (Baseline): Pain Education (WebED) (n=44): 56.44 (11.17); Web-based CBT (WebMAP) (n=46): 55.83 (12.01). T2 (Post-treatment, 12 weeks): Pain Education (WebED) (n=44): 56.65 (11.00); Web-based CBT (WebMAP) (n=46): 53.21 (13.28). T3 (6-month follow-up): Pain Education (WebED) (n=44): 53.3 (12.84); Web-based CBT (WebMAP) (n=46): 55.69 (10.71).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Change in Health Service Utilization [Baseline, 6 months]. Mean, number of visits (Standard Deviation). T1 Emergency Visits (Baseline): Pain Education (WebED) (n=44): 1.98 (1.92); Web-based CBT (WebMAP) (n=46): 2.73 (4.05). T3 Emergency Visits (6-month follow-up): Pain Education (WebED) (n=44): 1.62 (1.95); Web-based CBT (WebMAP) (n=46): 1.72 (2.15). T1 Outpatient Dr Visits (Baseline): Pain Education (WebED) (n=44): 4.71 (3.24); Web-based CBT (WebMAP) (n=46): 4.27 (3.01). T3 Outpatient Dr Visits (6-month follow-up): Pain Education (WebED) (n=44): 4.55 (3.03); Web-based CBT (WebMAP) (n=46): 4.35 (3.69).