Development and Adaptation of I-STRONG for SCD

Completed · Not applicable

Conditions studied: Sickle Cell Disease

In brief

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.

Key facts

Study ID

NCT06110754

Run by

Emory University

People needed

45

Starts

2023-06-08

Expected to finish

2024-06-14

Last updated by the study team

2025-12-19

Who can join

Age: 12 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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)

Where it is running

• Children's Healthcare of Atlanta (CHOA) — Atlanta, Georgia, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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