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

对患有镰状细胞痛的青少年和新兴成年人的同伴支持：促进认知行为治疗的参与

• 批准号: 10745058
• 负责人: Alicia Colvin
• 金额: $ 81.92万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-10 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10745058
• 关键词: Address; Adolescent; Adolescent and Young Adult; Adult; Advocate; Age; Anxiety; Behavioral; Black race; Caring; Chronic; Clinical; Cognitive; Cognitive Therapy; Communities; Data; Development; Disparity; E-learning; Education; Educational process of instructing; Effectiveness; Emergency department visit; Empathy; Enrollment; Exercise; Exposure to; Family member; Focus Groups; Future; General Population; Healthcare Systems; Hospitalization; Individual; Infrastructure; Intervention; Learning Skill; Libraries; Mental Depression; Mental Health; Minority Groups; Moods; Multicenter Trials; National Center for Advancing Translational Sciences; Opioid; Outcome; Pain; Pain intensity; Pain interference; Pain management; Parents; Participant; Patients; Persons; Phase; Population; Provider; Randomized; Randomized, Controlled Trials; Reporting; Research Design; Resources; Running; Secondary pain; Secure; Sickle Cell; Sickle Cell Anemia; Site; Stress; Symptoms; Technology; Testing; Text; Therapeutic Intervention; Therapy trial; Training; Voice; Work; adolescent health outcomes; behavioral health; chronic pain; clinical research site; community organizations; community partnership; compare effectiveness; coping; cost; daily pain; design; diaries; digital; digital intervention; digital treatment; effectiveness evaluation; emerging adult; evidence base; experience; handheld mobile device; healing; health care service utilization; human centered design; implicit bias; improved; innovation; internalized stigma; meetings; non-opioid analgesic; opioid use; pain outcome; pain reduction; pain symptom; patient engagement; peer; peer coaching; peer support; personalized approach; personalized learning; preference; prescription opioid; primary outcome; programs; psychologic; psychological outcomes; psychological symptom; psychosocial; racial bias; randomized trial; secondary outcome; social stigma; stressor; support network; telephone based; treatment as usual; treatment group; uptake; video chat; virtual delivery

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.

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 对于由于缺乏基于证据的疼痛治疗方法而导致该人群中的许多人，并且 医疗保健系统中的污名和隐性偏见。黑人青少年和年轻人（Ayas，16-30岁） SCD特别容易受到伤害，因为他们在应对时因疼痛犯罪而忍受重复住院 污名和相关的压力源，以及过渡到成年的其他挑战。阿片类药物是 用于慢性SCD疼痛管理的主要代理，使命证据表明它们提供了差的长期救济 并带来负面的身体和心理后果。教会认知的社会心理干预措施 行为策略可以轻松减轻疼痛和污名，并增强SCD患者的情绪。 认知行为疗法（CBT）是管理一般疼痛的主要行为健康方法 人口和数字CBT扩大了其可访问性。在SCD和其他少数民族中，我们有 证明CBT的低成本，可扩展，技术授权的版本是可行的，可以有效 解决压力和痛苦。我们了解到个性化支持可以改善与 数字CBT。现在，我们将使用同行支持测试使用SCD定制的个性化方法 通过基于社区的组织（CBO）交付。我们将进行多站点，随机控制的 数字CBT的试验，以了解减少疼痛和污名所需的益处所需的支持水平。 我们对青少年和有镰状细胞疼痛的新兴成年人的同伴支持：促进参与 认知行为疗法（存在）研究旨在减轻疼痛，阿片类药物的使用和医疗保健利用 与SCD的Ayas中。在UG3阶段，我们将利用已建立的基础设施进行交付 虚拟同行支持干预措施，由SCD和患者量身定制的现有数字CBT程序以及 与CBO建立合作伙伴关系，共同完善研究设计，数字CBT内容和同行支持部分以及 与Heal Ern CCC和DCC合作，为UH3试验做准备。在遇到UG3里程碑之后， 过渡到UH3阶段，我们将在过去的470 AYA中随机将疼痛频繁疼痛（4天/周）随机分配 3个治疗组之一的月份：1）每周提供一对一同行支持的数字CBT计划 通过基于参与者偏好（CBT+PEER）的文本和/或电话，2）相同的数字CBT程序 没有同伴支持（自引导CBT）或3）通常的护理（UC）。我们首先假设Ayas接受了 数字CBT治疗（CBT+ PEER或自助CBT）将具有比 AYA在6个月时接受UC。其次，我们假设CBT+对等将与改进相关联 与自导的CBT相比，计划参与，疼痛和心理健康成果。这 在场试验将确定数字CBT在AYAS中使用SCD的疼痛管理有效性 作为常规SCD护理的一部分，朝着未来大规模部署的关键一步。