Internet Based Cognitive Behavioral Therapy in Pediatric Chronic Pancreatitis
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|ClinicalTrials.gov Identifier: NCT03707431|
Recruitment Status : Recruiting
First Posted : October 16, 2018
Last Update Posted : January 2, 2020
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pancreatitis Acute Recurrent Pancreatitis||Behavioral: Web-based CBT Behavioral: Pain Education||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||260 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized and double-blinded controlled trial of web-based CBT (WebMAP) vs pain education (WebED).|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized Trial of a Web-based Non-pharmacological Pain Intervention for Pediatric Chronic Pancreatitis|
|Actual Study Start Date :||April 25, 2019|
|Estimated Primary Completion Date :||January 31, 2023|
|Estimated Study Completion Date :||May 31, 2023|
Experimental: Web-based CBT (WebMAP)
Receives access to WebMAP
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.
Other Name: WebMAP
Active Comparator: Pain Education (WebED)
Receives access to WebED
Behavioral: 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.
Other Name: WebED
- Change in abdominal pain severity [ Time Frame: 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.
- Change in pain-related disability [ Time Frame: 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.
- Change in health-related quality of life [ Time Frame: 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.
- Change in emotional distress [ Time Frame: Baseline, 12 weeks, 6 months ]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.
- Change in opioid use [ Time Frame: Baseline, 12 weeks, 6 months ]Youth and parents will report on over the counter and prescription (opioid and non-opioid) medication use in the preceding 7 days.
- Change in pain self-efficacy [ Time Frame: 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 indicate higher self-efficacy.
- Change in parent impact of pain [ Time Frame: 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 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.
- Change in pain interference [ Time Frame: Baseline, 12 weeks, 6 months ]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.
- Change in health service utilization [ Time Frame: 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 costs as reported by the parent.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03707431
|Contact: Tonya Palermo, PhDemail@example.com|
|Contact: Homer Aalfs, BSfirstname.lastname@example.org|
|United States, Washington|
|Seattle Children's Hospital||Recruiting|
|Seattle, Washington, United States, 98105|
|Principal Investigator: Tonya M Palermo, PhD|
|Principal Investigator:||Tonya Palermo, PhD||Seattle Children's Research Institute|
|Principal Investigator:||Aliye Uc, MD||University of Iowa|