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

抽象的。疼痛是镰状细胞病（SCD）的临床标志，但疼痛管理仍然不足 由于缺乏SCD的循证疼痛治疗方法， 医疗系统中的耻辱和隐性偏见。黑人青少年和年轻人（AYAs，16-30岁）， SCD是特别脆弱的，因为他们忍受反复住院治疗，由于疼痛危机，同时应对 耻辱和相关的压力因素，以及向成年过渡的其他挑战。阿片类药物是 用于慢性SCD疼痛管理的主要药物，尽管有证据表明它们提供的长期缓解效果较差 并导致负面的生理和心理后果。心理社会干预，教认知 行为策略可以同时减少SCD患者的疼痛和耻辱感，并改善情绪。 认知行为疗法（CBT）是管理疼痛的主要行为健康方法， 数字CBT扩大了其可访问性。在SCD和其他少数民族中，我们有 证明了CBT的低成本、可扩展、技术交付版本是可行的，也是有效的 来缓解压力和疼痛我们了解到，个性化支持可以提高与 数字CBT我们现在将测试一个个性化的方法定制的AYA与SCD使用同行支持 通过社区组织提供。我们将进行一项多中心随机对照 数字CBT的试验，以了解实现减少疼痛和耻辱的益处所需的支持水平。 我们对青少年和新生成人镰状细胞疼痛的同行支持：促进ENglycoin 认知行为疗法（PRESENCE）研究旨在减少疼痛、阿片类药物使用和医疗保健利用 在患有SCD的AYA中。在UG 3阶段，我们将利用已建立的基础架构来提供 虚拟同伴支持干预，由SCD患者量身定制的现有数字CBT计划，以及 与社区组织合作，共同完善研究设计、数字CBT内容和同行支持组件， 与HEAL ERN CCC和DCC合作，为UH 3试验做准备。在满足UG 3里程碑和 过渡到UH 3阶段，我们将随机抽取470名在过去3年中经常疼痛（每周3天）的AYA 3个月的3个治疗组之一：1）每周提供一对一同伴支持的数字CBT计划 基于参与者偏好（CBT+对等）通过文本和/或电话，2）相同的数字CBT程序 没有同伴支持（自我指导CBT），或3）常规护理（UC）。我们首先假设， 数字化CBT治疗（CBT+同伴或自我指导CBT）将有更好的疼痛和心理健康结果， 在6个月时接受UC的AYA。第二，我们假设CBT+peer将与改善 与自我指导的CBT相比，6个月时的计划参与度和疼痛及心理健康结果。的 PRESENCE试验将确定数字CBT在患有SCD的AYA中进行疼痛管理的有效性， 作为常规SCD护理的一部分，这是未来大规模部署的关键一步。

Abstract. Pain is the clinical hallmark of sickle cell disease (SCD), yet pain management remains inadequate for many in this population due to lack of evidence-based pain treatment approaches for SCD, and due to stigma and implicit bias in the healthcare system. Black adolescents and young adults (AYAs, ages 16-30) with SCD are particularly vulnerable as they endure repeat hospitalizations due to pain crises while coping with stigma and related stressors, as well as the other challenges of transitioning to adulthood. Opioids are the primary agent used in chronic SCD pain management, despite evidence that they provide poor long-term relief and lead to negative physical and psychological consequences. Psychosocial interventions that teach cognitive and behavioral strategies can simultaneously reduce pain and stigma and enhance mood in patients with SCD. Cognitive behavioral therapy (CBT) is the primary behavioral health approach to managing pain in the general population, and digital CBT has expanded its accessibility. In SCD and other minority populations, we have demonstrated that a low-cost, scalable, technology-delivered version of CBT is feasible and can be effective for addressing stress and pain. We have learned that personalized support can improve engagement with digital CBT. We will now test a personalized approach customized for AYAs with SCD using peer support delivered through community-based organizations (CBOs). We will conduct a multisite, randomized controlled trial of digital CBT to understand the level of support needed to achieve benefits for reducing pain and stigma. Our Peer suppoRt for adolescents and Emerging adults with Sickle cell pain: promoting ENgagement in Cognitive behavioral thErapy (PRESENCE) study aims to reduce pain, opioid use, and healthcare utilization among AYAs with SCD. During the UG3 phase, we will leverage an established infrastructure for delivering virtual peer support interventions, existing digital CBT programs tailored by and for people with SCD, and partnerships with CBOs to jointly refine the study design, digital CBT content, and peer support component and work with the HEAL ERN CCC and DCC to prepare for the UH3 trial. After meeting UG3 milestones and transitioning to the UH3 phase, we will randomize 470 AYAs with frequent pain (³4 days/wk) over the past ³3 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) usual care (UC). We first 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. Second, 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. The PRESENCE trial will determine effectiveness of digital CBT for pain management among AYAs with SCD, a critical step toward future wide-scale deployment as part of routine SCD care.