N/A
Completed N=90
Internet Based Cognitive Behavioral Therapy in Pediatric Chronic Pancreatitis
Acute Pancreatitis · Acute Recurrent Pancreatitis
Source: ClinicalTrials.gov NCT03707431 ↗
Enrolled (actual)
90
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcomePrimary: Change in Adolescent Abdominal Pain Severity — 2.11; 1.74; 1.99; 1.61 scores on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Adolescent Abdominal Pain Severity |
2.11; 1.74; 1.99; 1.61; 1.62; 1.48 | — |
| SECONDARY Change in Pain-related Disability |
22.03; 20.47; 22.09; 18.95; 24.24; 16.48 | — |
| SECONDARY Change in Health-related Quality of Life |
59.59; 60.73; 62.27; 64.03; 64.10; 64.81 | — |
| SECONDARY Change in Emotional Distress |
50.97; 50.53; 51.22; 50.20; 50.04; 51.10 | — |
| SECONDARY Change in Opioid Use |
9; 6; 35; 40; 7; 4 | — |
| SECONDARY Change in Pain Self-efficacy |
21.76; 22.72; 19.78; 21.11; 20.37; 20.3 | — |
| SECONDARY Change in Parent Impact of Pain |
13.67; 13.57; 13.31; 12.01; 12.21; 12.37 | — |
| SECONDARY Change in Pain Interference |
56.44; 55.83; 56.65; 53.21; 53.3; 55.69 | — |
| SECONDARY Change in Health Service Utilization |
1.98; 2.73; 1.62; 1.72; 4.71; 4.27 | — |
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
Data sourced from ClinicalTrials.gov (NCT03707431). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.