Status:
COMPLETED
Development and Adaptation of I-STRONG for SCD
Lead Sponsor:
Emory University
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Sickle Cell Disease
Eligibility:
All Genders
12-18 years
Phase:
NA
Brief Summary
This study develops and tests the feasibility and acceptability of an adapted intervention, Integrative Strong Body and Mind Training (I-STRONG), in adolescents with pain from sickle cell disease.
Detailed Description
Pain is the hallmark feature of sickle cell disease (SCD), a life-limiting chronic illness that disproportionately affects African Americans. Well-documented racial disparities complicate effective pa...
Eligibility Criteria
Inclusion
- Diagnosed with SCD (any genotype)
- Score of at least 3 (indicating medium to high risk for chronic pain) on the Pediatric Pain Screening Tool
- Stable disease-modifying treatments, if applicable, as defined by no newly initiated or significantly increased dosages (mg/kg) in the past 3 months (Aim 2 only)
- English fluency (Aim 2 only)
Exclusion
- Comorbid medical conditions typically associated with pain but unrelated to SCD (e.g., rheumatologic disorders or inflammatory bowel disease)
- Presence of a condition(s) or diagnosis, either physical or psychological, or physical exam finding that precludes participation (e.g., severe avascular necrosis with limited or non-weight bearing restrictions, significant cognitive or developmental limitations, active suicidal ideation) (Aim 2 only)
- Adolescent receiving active treatment (e.g., weekly appointments with a provider) for nonpharmacological therapies (e.g, structured behavioral pain management, physical therapy, or acupuncture program) that overlap with the active phase of the study intervention (Aim 2 only)
Key Trial Info
Start Date :
June 8 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 14 2024
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT06110754
Start Date
June 8 2023
End Date
June 14 2024
Last Update
December 19 2025
Active Locations (2)
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1
Children's Healthcare of Atlanta (CHOA)
Atlanta, Georgia, United States, 30322
2
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229