N/A
Completed N=45
Development and Adaptation of I-STRONG for SCD
Source: ClinicalTrials.gov NCT06110754 ↗Enrolled (actual)
45
Serious AEs
33.3%
Results posted
Dec 2025
Primary outcomePrimary: Brief Pain Inventory (BPI) Pain Severity Score — 5.75; 4.36; 3.89 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Brief Pain Inventory (BPI) Pain Severity Score |
5.75; 4.36; 3.89 | — |
| SECONDARY Brief Pain Inventory (BPI) Pain Interference Score |
3.45; 4.24; 2.94 | — |
| SECONDARY Patient Health Questionnaire (PHQ-8) Score |
6.50; 5.33; 6.82; 5.11; 5.40; 5.22 | — |
| SECONDARY General Anxiety Disorder (GAD-2) Score |
2.08; 2.11; 1.45; 1.11; 1.20; 1.11 | — |
| SECONDARY Pain Catastrophizing Scale Score |
24.33; 28.33; 22.82; 30.56; 21.00; 26.33 | — |
| SECONDARY Pediatric Quality of Life Inventory (PedsQL) Score |
69.03; 64.85; 73.83 | — |
| SECONDARY Adolescent Sleep-Wake Scale (ASWS) Score |
38.00; 37.55; 41.00 | — |
| SECONDARY National Institute on Drug Abuse (NIDA)-Modified ASSIST (NM ASSIST) Tool Level 2 |
0.58; 0.50 | — |
| SECONDARY Days of Opioid Use Per Week |
1.00; 1.70; 2.25 | — |
| SECONDARY Change in Patient Global Impression of Change (PGIC) Score |
1.36; 1.44 | — |
| SECONDARY Treatment Evaluation Inventory-Short Form (TEI-SF) Score |
34.36; 33.30 | — |
| SECONDARY Tampa Scale of Kinesiophobia (TSK) Score |
25.42; 25.82; 24.00 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT06110754). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.