Digital cognitive behavioral therapy and peer support for adolescents and young adults with sickle cell disease and chronic pain: study protocol of a parallel, three-arm, randomized controlled trial (PRESENCE).

Résumé

BACKGROUND: Sickle cell disease (SCD) affects millions globally, with pain being the most prevalent symptom. Adolescents and young adults (AYAs) with SCD face high rates of pain crises and healthcare encounters. Digital cognitive behavioral therapy (CBT) shows promise for pain management but faces engagement challenges. The PRESENCE study aims to enhance engagement in and benefit from digital CBT for SCD by adding personalized peer support.METHODS: This multisite, randomized controlled trial is recruiting 470 AYAs (ages 16-30) with SCD who report chronic pain. Participants are randomized 3:3:2 respectively to one of three groups: (1) CBT with peer support (CBT + Peer), (2) CBT alone (CBT), or (3) usual care (UC). Participants are provided access to the study mobile application, which is used for intervention delivery and data collection. Peer support is provided weekly by trained peer coaches who are individuals with lived experience. Evaluations are completed at baseline, 3, 6, and 12 months post randomization. The primary study aim is to determine whether AYAs receiving any digital CBT have greater reductions in pain intensity and pain interference at 6 months post randomization compared to those receiving UC. The secondary aim is to determine whether CBT + Peer is superior to CBT in reducing pain intensity and interference at 6 months. Secondary outcomes include reductions in mean daily pain intensity, pain days, average weekly opioid dose, emergency department visits, healthcare utilization, internalized stigma, and depression and anxiety symptoms, and improvements in sickle cell self-efficacy.DISCUSSION: Findings from the PRESENCE trial will inform patients, parents, and providers on how digital CBT and peer support will improve pain management. Ultimately, this study will advance our understanding of how digital interventions can be optimized for populations with complex chronic conditions like SCD, where stigma and healthcare navigation can be barriers to effective care delivery. This approach could offer a scalable, accessible, and culturally responsive strategy to improve pain outcomes, reduce opioid reliance, and enhance overall health and well-being for AYAs with SCD.TRIAL REGISTRATION: Clinicaltrials.gov NCT06374238. Registered on April 2025.