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)的临床特征，但疼痛管理仍不充分 对于这一人群中的许多人来说，由于缺乏针对SCD的循证疼痛治疗方法，以及由于 医疗体系中的耻辱和隐性偏见。黑人青少年和青壮年(AYA，16-30岁) SCD尤其脆弱，因为他们在应对 耻辱和相关的压力源，以及过渡到成年的其他挑战。阿片类药物是 用于慢性SCD疼痛治疗的主要药物，尽管有证据表明它们长期缓解效果不佳 并导致负面的生理和心理后果。教育认知的心理社会干预 行为策略可以同时减轻SCD患者的疼痛和耻辱，并增强患者的情绪。 认知行为疗法(CBT)是治疗疼痛的主要行为健康方法。 数字CBT扩大了其可及性。在SCD和其他少数群体中，我们有 证明了低成本、可扩展、技术交付的CBT版本是可行的，也是有效的 用来应对压力和痛苦。我们了解到，个性化支持可以提高与 数字CBT。现在，我们将使用同行支持，通过SCD测试为AYA定制的个性化方法 通过基于社区的组织(CBO)提供。我们将进行多点、随机对照 试验数字CBT，以了解为实现减轻疼痛和耻辱的益处所需的支持水平。 我们为患有镰状细胞疼痛的青少年和新兴成年人提供的同行支持：促进参与 认知行为疗法(Presence)研究旨在减少疼痛、阿片类药物的使用和医疗保健的利用 在患有SCD的AYA中。在UG3阶段，我们将利用现有的基础设施来交付 虚拟同伴支持干预，由SCD患者定制的现有数字CBT计划，以及 与CBO合作，共同完善研究设计、数字CBT内容和同行支持部分，以及 与REAL ERN CCC和DCC合作，为UH3试验做准备。在达到UG3里程碑和 过渡到UH3阶段，我们将随机选择470名在过去4天/周有频繁疼痛的AYA 3个治疗组中的一个：1)每周提供一对一同伴支持的数字CBT计划 基于参与者偏好的文本和/或电话(CBT+Peer)，2)相同的数字CBT节目 没有同伴支持(自我指导的CBT)，或3)常规护理(UC)。我们首先假设AYAS收到的是 数字CBT治疗(CBT+同伴或自我指导CBT)将比 Ayas在6个月时接受UC治疗。其次，我们假设CBT+Peer将与改进的 与自我指导的CBT相比，6个月后的计划参与度、疼痛和心理健康结果。这个 现场试验将确定数字CBT对患有SCD的AYA患者疼痛管理的有效性 作为常规SCD护理的一部分，迈向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.