Trial results for the Integrative Strong Body and Mind Training (I-STRONG) intervention in adolescents with Sickle Cell Disease were posted on ClinicalTrials.gov on 2025-12-19, detailing feasibility and acceptability in 45 participants.
Background
Sickle cell disease (SCD) is a genetic blood disorder characterized by chronic pain, which significantly impacts the quality of life for affected individuals, particularly adolescents. Pain crises are a hallmark of SCD, often leading to hospitalizations and long-term complications. Managing this chronic pain often requires a multifaceted approach, including pharmacological and non-pharmacological strategies. Interventions that address both physical and mental well-being are crucial for adolescents navigating the challenges of SCD. The development of adapted programs like I-STRONG aims to provide comprehensive support, focusing on pain management and mental health in this vulnerable population.
Trial design
This completed study, identified as Phase NA, enrolled 45 participants with Sickle Cell Disease. The trial's primary objective was to develop and test the feasibility and acceptability of an adapted intervention, Integrative Strong Body and Mind Training (I-STRONG), specifically for adolescents experiencing pain from sickle cell disease. The study did not list specific primary outcomes but focused on evaluating the intervention's practical application and participant reception. The intervention, I-STRONG, was designed to support adolescents with SCD.
Key results
The trial results provide various measurements for pain severity, pain interference, and depressive symptoms for adolescents with SCD and their parents following the I-STRONG intervention:
- For adolescents with SCD, the Brief Pain Inventory (BPI) Pain Severity Scores were observed with a mean of 5.75 (Standard Deviation 2.63), a mean of 4.36 (Standard Deviation 1.96), and a mean of 3.89 (Standard Deviation 2.15) units on a scale.
- Adolescents with SCD also showed Brief Pain Inventory (BPI) Pain Interference Scores with a mean of 3.45 (Standard Deviation 3.09), a mean of 4.24 (Standard Deviation 2.62), and a mean of 2.94 (Standard Deviation 2.15) units on a scale.
- Patient Health Questionnaire (PHQ-8) Scores for adolescents with SCD were reported with a mean of 6.50 (Standard Deviation 5.69), a mean of 6.82 (Standard Deviation 6.52), and a mean of 5.40 (Standard Deviation 3.41) on a scale.
- For parents of adolescents with SCD, Patient Health Questionnaire (PHQ-8) Scores were observed with a mean of 5.33 (Standard Deviation 4.8), a mean of 5.11 (Standard Deviation 7.8), and a mean of 5.22 (Standard Deviation 7.6) on a scale.
What this means
The posted results offer initial insights into pain severity, pain interference, and depressive symptoms among adolescents with sickle cell disease and their parents who participated in the I-STRONG intervention. While the study primarily focused on feasibility and acceptability, the reported mean scores provide baseline data points for these outcomes within the study population. For instance, the BPI Pain Severity Scores for adolescents ranged from a mean of 3.89 to 5.75, indicating varying levels of pain experience. Similarly, the PHQ-8 scores for both adolescents and parents provide a snapshot of depressive symptom levels. These findings contribute to understanding the potential impact of such an intervention and can inform the design of future efficacy trials for pain and mental health management in adolescents with SCD.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT06110754, titled "Development and Adaptation of I-STRONG for SCD", were posted on 2025-12-19 on clinicaltrials.gov.