Sickle cell disease (SCD) is a condition that is associated with pain, medical complications related to vaso-occlusive episodes, and psychological stress. These complications can impact health-related quality of life for patients with SCD.
Researchers from the University of Pittsburgh in Pittsburgh, Pennsylvania, and other research institutions are conducting a study evaluating the performance of 2 smartphone-based interventions in addressing SCD pain outcomes. Details of the study were reported in a recent issue of JMIR Research Protocols.
“Current standards for pain management in SCD are unsatisfactory and primarily focus on opioids, with little evidence for nonpharmacological interventions in this population,” the researchers explained in their report.
In the randomized Cognitive Behavioral Therapy and Real-Time Pain Management Intervention for Sickle Cell via Mobile Applications study (CaRISMA; ClinicalTrials.gov Identifier: NCT04419168), adult patients with SCD are being recruited in person at 6 academic sites and online through 4 community-based organizations.
The CaRISMA trial includes 2 study arms, involving either cognitive behavioral therapy (CBT arm; 175 patients) or SCD education (Education arm; 175 patients). Both interventions are 12-week programs delivered via smartphone and include health-coach support. A chatbot app and an online support group are also provided.
The CBT intervention emphasizes the development of coping skills and learning through practice. The Education intervention emphasizes development of knowledge about SCD, pain, and lifestyle recommendations.
The primary study outcome is the change in pain interference at particular intervals, and the secondary outcome is change in daily pain intensity. Another objective is to examine whether there is a relationship between baseline depression symptoms and pain outcomes. Other outcomes are also being assessed in this trial, such as medical outcomes, quality-of-life outcomes, adverse events with the intervention, and others. For assessment of the primary pain outcome, patients receive a questionnaire at baseline and at 3, 6, and 12 months.
“The CaRISMA trial will fill a knowledge gap in the SCD literature by evaluating the effectiveness of two remotely delivered pain management programs for adults with SCD: digital CBT and digital Education,” the researchers wrote in their report. The study is expected to be completed in October 2022, with results anticipated in February 2023.
Badawy SM, Abebe KZ, Reichman CA, et al. Comparing the effectiveness of education versus digital cognitive behavioral therapy for adults with sickle cell disease: protocol for the Cognitive Behavioral Therapy and Real-time Pain Management Intervention for Sickle Cell via Mobile Applications (CaRISMA) study. JMIR Res Protoc. 2021;10(5):e29014. doi:10.2196/29014