Peer suppoRt for adolescents and Emerging adults with Sickle cell pain: promoting ENgagement in Cognitive behavioral thErapy

University Of Pittsburgh At Pittsburgh, Pittsburgh PA

Investigators

Abstract

Pain management in sickle cell disease (SCD) is inadequate, especially for Black adolescents and young adults (AYAs) who face psychosocial stressors and challenges transitioning to adulthood. Opioids, the primary treatment, provide poor long-term relief and have negative consequences. Cognitive behavioral therapy (CBT) can reduce pain and stress, and digital CBT has increased accessibility. The PRESENCE study, funded under the UG3/UH3 mechanism, aims to test a personalized digital CBT intervention with peer support, compared to usual care (UC) and self-guided CBT. This study will determine which intervention most effectively reduces pain, opioid use, and healthcare utilization among AYAs with SCD. During the UG3 phase, we leveraged the NIH’s Helping to End Addiction Long-term (HEAL) Pain Management Effectiveness Research Network (ERN) resource centers and community partnerships to jointly refine the study design, participating sites, adapt the intervention, and peer support component in preparation for the UH3 trial. We have made significant progress toward completing the UG3 milestones and are preparing for our transition to the UH3 phase in Fall of 2024. However, we encountered unanticipated expenses and identified necessary modifications within the original scope of the project that will increase its overall impact in the UH3 phase. To address these gaps and ensure successful execution of the trial, we are requesting NIH HEAL Initiative funds through the PA-20-272 parent administrative supplement mechanism. This administrative supplement application addresses three critical gaps identified during the UG3 phase. First, the need for additional peer health coaches to manage the higher-than-expected demand for peer coaching, as indicated in the grant summary statement and from preliminary data collected that informs this trial. Second, the unanticipated requirement for a site-agnostic coordinator to support the UH3 trial's decentralized enrollment and on-call support across all sites. Third, the necessity of a trained centralized safety research coordinator (SRC) to implement the suicide risk management protocol developed during the UG3 phase. The additional resources and infrastructure will ensure the successful conduct of a clinical trial in the UH3 phase, where we will randomize 470 AYAs with frequent pain (≥4 days/week) over the past ≥3 months to one of 3 treatment groups: 1) a digital CBT program with weekly one-on-one peer support provided via text and/or telephone based on participant preference (CBT+peer), 2) the same digital CBT program without peer support (self-guided CBT), or 3) UC. We hypothesize that AYAs receiving either digital CBT treatment (CBT+peer or self-guided CBT) will have better pain and mental health outcomes than AYAs receiving UC at 6 months. Additionally, we hypothesize that CBT+peer will be associated with improved program engagement and pain and mental health outcomes at 6 months compared with self-guided CBT. This trial is a critical step toward future wide-scale deployment as part of routine SCD care.