Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
137 participants
INTERVENTIONAL
2018-01-01
2022-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Education Control
In addition to standard medical care, youth in the education control group will be provided with access to a self-guided education study website, which will contain static education about SCD (no self-management skills, goal-setting, or social support content) to access over 8-weeks.
Education
Education about sickle cell disease to increase disease knowledge
Pain Self-Management Intervention
In addition to standard medical SCD care, youth in the pain self-management intervention group will receive the iCanCope with SCD mobile intervention including goal-setting, peer social support, and pain self-management skills over a period of 8 weeks.
Pain self-management
The program is designed to enhance self-efficacy. The app will guide youth in setting structured and personalized goals aimed at improving their pain and functioning. The pain self-management skills will include personalized CBT-based coping skills including deep breathing, relaxation, and cognitive skills (e.g., staying positive). The app will provide in-the-moment access to pain coping strategies to promote positive changes in mood, behavior, and pain.
Education
Education about sickle cell disease to increase disease knowledge
Interventions
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Pain self-management
The program is designed to enhance self-efficacy. The app will guide youth in setting structured and personalized goals aimed at improving their pain and functioning. The pain self-management skills will include personalized CBT-based coping skills including deep breathing, relaxation, and cognitive skills (e.g., staying positive). The app will provide in-the-moment access to pain coping strategies to promote positive changes in mood, behavior, and pain.
Education
Education about sickle cell disease to increase disease knowledge
Eligibility Criteria
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Inclusion Criteria
* diagnosed with any type of SCD
* able to speak and read English
* score at least 4 (indicating some days with pain interference over the past month) on the Sickle Cell Pain Burden Interview
* willing and able to complete online measures
Exclusion Criteria
* have previously received more than 4 sessions of outpatient psychological therapy for pain management in the 6 months prior to the time of screening.
12 Years
18 Years
ALL
No
Sponsors
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The Hospital for Sick Children
OTHER
Emory University
OTHER
Connecticut Children's Medical Center
OTHER
University of Mississippi Medical Center
OTHER
University of Florida
OTHER
Boston Medical Center
OTHER
Northwestern University
OTHER
Seattle Children's Hospital
OTHER
Responsible Party
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Tonya Palermo
Professor, Anesthesiology and Pain Medicine
Principal Investigators
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Tonya M Palermo, PhD
Role: PRINCIPAL_INVESTIGATOR
Seattle Children's Hospital
Locations
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Connecticut Children's Medical Center
Hartford, Connecticut, United States
Emory University
Atlanta, Georgia, United States
Seattle Children's Hospital
Seattle, Washington, United States
The Hospital for Sick Children
Toronto, Ontario, Canada
Countries
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References
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Palermo TM, Srinakarin K, Zhou C, Lalloo C, Dampier C, Zempsky WT, Badawy SM, Bakshi N, Ko YJ, Nishat F, Stinson JN. Moderators of digital cognitive-behavioral therapy for youth with sickle cell disease pain: secondary analysis of a randomized controlled trial. Pain. 2025 Mar 13;166(9):e233-e243. doi: 10.1097/j.pain.0000000000003583.
Palermo TM, Lalloo C, Zhou C, Dampier C, Zempsky W, Badawy SM, Bakshi N, Ko YJ, Nishat F, Stinson JN. A cognitive-behavioral digital health intervention for sickle cell disease pain in adolescents: a randomized, controlled, multicenter trial. Pain. 2024 Jan 1;165(1):164-176. doi: 10.1097/j.pain.0000000000003009. Epub 2023 Sep 21.
Lalloo C, Nishat F, Zempsky W, Bakshi N, Badawy S, Ko YJ, Dampier C, Stinson J, Palermo TM. Characterizing User Engagement With a Digital Intervention for Pain Self-management Among Youth With Sickle Cell Disease and Their Caregivers: Subanalysis of a Randomized Controlled Trial. J Med Internet Res. 2022 Aug 30;24(8):e40096. doi: 10.2196/40096.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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