Internet Based Cognitive Behavioral Therapy in Pediatric Chronic

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03707431
Study type	Interventional
Source	Seattle Children's Hospital
Contact
Status	Active, not recruiting
Phase	N/A
Start date	April 25, 2019
Completion date	July 31, 2024

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03112759` - Assessing the Utility of Cognitive Behavioral Therapy for Pain Control in Patients With Chronic Pancreatitis	N/A
Enrolling by invitation	`NCT05410795` - Establishment and Verification of Pancreatic Volume Formula Based on Imaging
Active, not recruiting	`NCT02965898` - The Effect of Vitamin D Substitution on the Development of Chronic Pancreatitis	N/A
Completed	`NCT02868047` - Establishing Standards for Normal Pancreatic EUS	N/A
Completed	`NCT01452217` - Non-invasive MRI to Quantify the Effect of Secretin on Pancreatic Blood Flow and Perfusion in Healthy Volunteers	Phase 1
Completed	`NCT00685087` - A Prospective Study of Natural History of Pancreatitis	N/A
Completed	`NCT04949828` - Effect of CREON on Exocrine Pancreatic Insufficiency (EPI) Symptoms
Recruiting	`NCT06068426` - Incorporating Endoscopic Ultrasound and Elastography Towards Improving Outcomes of Pediatric Pancreatitis Management	N/A
Recruiting	`NCT05042284` - Effect of Non-enteric Coated Enzymes Substitution on Pain in Patients With Chronic Pancreatitis	N/A
Active, not recruiting	`NCT05764629` - An Observational Study on Post-chronic Pancreatitis Diabetes Mellitus
Completed	`NCT03850977` - Is There an Association Between Chronic Pancreatitis and Pulmonary Function
Recruiting	`NCT05692596` - The Pancreas Interception Center (PIC) for Early Detection, Prevention, and Novel Therapeutics
Recruiting	`NCT06015945` - Role of Home-based Transcutaneous Electrical Acustimulation for Treatment of Pain in Patients With Chronic Pancreatitis	N/A
Completed	`NCT04619511` - Risk Factors for Post-ESWL and Post-ERCP Pancreatitis
Completed	`NCT03283566` - Hydroxychloroquine and Metabolic Outcomes in Patients Undergoing TPAIT	Phase 2
Recruiting	`NCT03434392` - QST Study: Predicting Treatment Response in Chronic Pancreatitis Using Quantitative Sensory Testing	N/A
Not yet recruiting	`NCT05540197` - Arginine-stimulated Prediction of Early Outcome After Islet Transplantation
Completed	`NCT01430234` - Enzyme Suppletion in Exocrine Pancreatic Dysfunction	Phase 4
Completed	`NCT01318369` - Efficacy Study of Δ9-THC to Treat Chronic Abdominal Pain	Phase 2
Terminated	`NCT01442454` - Endoscopic Ultrasound (EUS) Features of Chronic Pancreatitis	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Internet Based Cognitive Behavioral Therapy in Pediatric Chronic Pancreatitis

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms