JMIR Publications

ABSTRACT

Background:

Background:

Patients with sickle cell disease (SCD) suffer a significant disease burden that affects their psychosocial well-being. Digital cognitive-behavioral therapy (CBT) has been utilized in other patient populations with clinical benefits. Although evidence-based, non-pharmacological interventions for pain management are widely used in other populations, this is not well studied in SCD. There are currently no large-scale, adequately powered clinical trials that evaluated the effectiveness and dissemination potential of digital behavioral pain management interventions for adults with SCD. Further, some important details remain unclear in SCD, in particular, what works best for whom and when.

Objective:

Objective:

Our primary goal is to compare the effectiveness of two mobile-phone–delivered programs for reducing SCD pain symptoms, digital cognitive behavioral therapy (digital CBT) versus pain and SCD education. Our secondary goal is to assess whether baseline depression symptoms moderate the effect of interventions on pain outcomes. We hypothesize that digital CBT will confer greater benefit on pain outcomes and depressive symptoms at 6 months. We also hypothesize that digital CBT will confer greater reduction in health care utilization (e.g., opioid prescriptions/refills, acute care visits) over 12 months.

Methods:

Methods:

Cognitive Behavioral Therapy and Real-Time Pain Management Intervention for Sickle Cell via Mobile Application (CaRISMA) is a multisite, pragmatic, randomized, comparative effectiveness trial funded by the Patient-Centered Outcomes Research Institute. CaRISMA is conducted at six clinical academic sites, with partnership and support from three community-based organizations (CBOs). In CaRISMA, we will evaluate the effectiveness of two 12-week, health coach supported, digital health programs with a total of 350 participants, CBT (n=175) and Education (n=175). Participants will complete a series of questionnaires at baseline, 3, 6, and 12 months. The primary outcome will be the change in pain interference between study arms. We will also evaluate changes in pain intensity, depressive symptoms, other patient-reported outcomes, and healthcare utilization as secondary outcomes. We have 80% power to detect a difference of 0.37 standard deviations between study arms on 6-month changes in the outcomes with expected 15% attrition at 6 months. An exploratory analysis will examine whether baseline depression symptoms moderate the effect of intervention on pain interference.

Results:

Results:

This study will be conducted from March 2021 through February 2022 with results expected to be available in Feb 2023.

Conclusions:

Conclusions:

Patients with SCD have disease burden and impairment of their health-related quality of life, particularly psychosocial and mental domains. CaRISMA proposes to leverage digital technology and overcome barriers to routine use of behavioral treatments for pain and depressive symptoms in adult SCD. The study will provide data on the comparative effectiveness of digital CBT and Education approaches and evaluate the potential for implementing evidence-based behavioral interventions for management of SCD pain. Clinical Trial: Trial Registration: NCT04419168.