Internet Based Cognitive Behavioral Therapy in Pediatric Chronic Pancreatitis

Chronic Pancreatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03707431
• Other study ID #: 1R01DK118752-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 25, 2019
• Est. completion date: July 31, 2024

Study information

• Verified date: January 2024
• Source: Seattle Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Recurrent Pancreatitis
• Chronic Pancreatitis
• Pancreatitis
• Pancreatitis, Chronic

Intervention

Behavioral:
• Web-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.
• Pain 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.

Locations

Country	Name	City	State
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (24)

Lead Sponsor

Collaborator

Seattle Children's Hospital

Ariel Precision Medicine, Cedars-Sinai Medical Center, Children's Hospital Los Angeles, Children's Hospital Medical Center, Cincinnati, Children's Hospital of Philadelphia, Indiana University, M.D. Anderson Cancer Center, Massachusetts General Hospital, McGill University Health Centre/Research Institute of the McGill University Health Centre, Medical College of Wisconsin, Ohio State University, Stanford University, Sydney Children's Hospitals Network, The University of Texas Health Science Center, Houston, University of California, San Francisco, University of Iowa, University of Minnesota, University of Pittsburgh, University of Texas Southwestern Medical Center, University of Toronto, University of Utah, University of Virginia, Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (1)

Palermo TM, Murray C, Aalfs H, Abu-El-Haija M, Barth B, Bellin MD, Ellery K, Fishman DS, Gariepy CE, Giefer MJ, Goday P, Gonska T, Heyman MB, Husain SZ, Lin TK, Liu QY, Mascarenhas MR, Maqbool A, McFerron B, Morinville VD, Nathan JD, Ooi CY, Perito ER, Pohl JF, Schwarzenberg SJ, Sellers ZM, Serrano J, Shah U, Troendle D, Zheng Y, Yuan Y, Lowe M, Uc A; Consortium for the Study of Chronic Pancreatitis, Diabetes and Pancreatic Cancer. 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). Contemp Clin Trials. 2020 Jan;88:105898. doi: 10.1016/j.cct.2019.105898. Epub 2019 Nov 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in abdominal pain severity	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.	Baseline, 12 weeks, 6 months
Secondary	Change in pain-related disability	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.	Baseline, 12 weeks, 6 months
Secondary	Change in health-related quality of life	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.	Baseline, 12 weeks, 6 months
Secondary	Change in emotional distress	The Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Emotional Distress Scales include an 8-item scale of anxiety that assesses fear (e.g., fearfulness), anxious misery (e.g., worry) and hyperarousal (e.g., nervousness) and 8-item scale of 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 symptoms.	Baseline, 12 weeks, 6 months
Secondary	Change in opioid use	Youth and parents will report on over the counter and prescription (opioid and non-opioid) medication use in the preceding 7 days.	Baseline, 12 weeks, 6 months
Secondary	Change in pain self-efficacy	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 indicate higher self-efficacy.	Baseline, 12 weeks, 6 months
Secondary	Change in parent impact of pain	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 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 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.	Baseline, 12 weeks, 6 months
Secondary	Change in pain interference	The PROMIS Pain Interference - Pediatric Short Form 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 symptoms.	Baseline, 12 weeks, 6 months
Secondary	Change in health service utilization	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.	Baseline, 6 months