Description

The PRESENCE study aims to address the pressing issue of inadequate pain management for adolescents and young adults (AYAs) with sickle cell disease (SCD). Despite pain being the primary clinical symptom of SCD, effective treatment options are limited, leading to repeated hospitalizations and negative impacts on patients' physical and mental well-being. Opioids, the primary treatment for chronic SCD pain, often fail to provide long-term relief and can result in harmful consequences.

Recognizing the need for alternative approaches, the study hopes to investigate the effectiveness of digital cognitive behavioral therapy (CBT), both with and without personalized peer support delivered through community-based organizations (CBOs). CBT is a well-established method for managing pain in the general population, and digital CBT has shown promise in improving outcomes for individuals with chronic conditions.

The study will involve a multisite, randomized controlled trial with 470 AYAs with SCD who have experienced frequent pain over the past three months. Participants will be randomized into one of three groups:

1. Digital CBT with weekly one-on-one peer support (CBT+peer)
2. Digital CBT without peer support (self-guided CBT)
3. Usual care (UC)

The primary hypotheses of the study are:

Hypothesis 1. AYAs receiving any digital CBT (CBT + peer or self-guided CBT) will have greater improvements in primary pain outcomes (PEG-3 pain intensity and pain interference), and larger decreases in secondary pain outcomes (mean daily pain intensity, pain days, average weekly opioid dose, emergency department visits, hospitalizations) and in psychological outcomes (MoSCS internalized stigma, SCSES sickle cell self-efficacy, PHQ-9M depression, GAD-7 anxiety) than AYAs receiving UC at 6 months post initiation of intervention.

Hypothesis 2. AYAs receiving CBT + peer will have greater improvements in the primary and secondary outcomes described above at 6 months, and greater app engagement, than AYAs receiving self-guided CBT.

This study will have the following assessment time points.

• Baseline = pre-randomization baseline measures
  • Rescreen if SCD verification is not provided within 30 days
• At Randomization = Pain and mood diary using Ecological Momentary Assessment (EMA) assessed daily for a total of 14 days with the first entry occuring immediately prior to randomization/intervention start and then continuing daily post-randomization
• 3-month = end of intervention period assessment 90 days (3 months) post -randomization
• 6-month = primary endpoint 180 days (6 months) post-randomization
• 12-month = long-term endpoint 365 days (12 months) post-randomization

The study intervention and EMA data collection is performed via an iOS and Android application called CaRISMA that will be called "the app" or the "CaRISMA app" hereafter.