Evaluation of the efficacy and mechanisms of a novel intervention for chronic pain tailored to people living with HIV

评估针对艾滋病毒感染者量身定制的慢性疼痛新型干预措施的功效和机制

• 批准号: 10397398
• 负责人: Jessica S Merlin
• 金额: $ 51.98万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-07-18 至 2024-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10397398
• 关键词: Academy; Accident and Emergency department; Acquired Immunodeficiency Syndrome; Address; Affect; Area; Behavior Therapy; Behavioral; Behavioral trial; Caring; Clinical; Collaborations; Disease; Dissemination and Implementation; Ensure; Failure; Future; General Population; Goals; HIV; Health; Impairment; Informal Social Control; Intervention; K-Series Research Career Programs; Low Back Pain; Mediating; Mediator of activation protein; Medicine; Musculoskeletal Pain; Neurobiology; Neurofibromin 2; Normal tissue morphology; Opiate Addiction; Opioid; Outcome; Pain; Pain management; Participant; Patient Preferences; Patients; Persistent pain; Persons; Physical Function; Population; Prevalence; Primary Health Care; Process; Public Health; Quality of life; Randomized; Recording of previous events; Reporting; Research; Research Personnel; Research Priority; Self Efficacy; Severities; System; Testing; United States Dept. of Health and Human Services; United States National Institutes of Health; Vulnerable Populations; Work; addiction; antiretroviral therapy; arm; base; chronic pain; chronic pain management; comorbidity; depressive symptoms; efficacy evaluation; efficacy outcomes; emotional functioning; expectation; experience; functional disability; healing; implementation study; improved; improved functioning; innovation; intervention mapping; mortality risk; novel; opioid epidemic; opioid overdose; pain scale; pain self-management; painful neuropathy; peer; pilot trial; prescription opioid; randomized trial; skill acquisition; skills; social cognitive theory; success; theories; therapy development; treatment as usual

Project Summary: Behavioral interventions for chronic pain among people living with HIV (PLWH) are an understudied area, with great potential to improve pain and function. Chronic pain is an important comorbidity that affects between 30% and 85% of PLWH and is associated with greater odds of functional impairment, increased emergency room utilization, suboptimal retention in HIV care, and failure to achieve virologic suppression. What is not known is how to optimally address chronic pain in this population. Opioids are a commonly used treatment for chronic pain, particularly in PLWH. Opioid prescribing for chronic pain often does not result in substantial improvement in outcomes and contributes to the growing epidemic of opioid addiction and overdose. In contrast, behavioral interventions are among the most effective and safest treatments for chronic pain in the general population. Pain Self-Management (PSM) is a Social Cognitive Theory (SCT)-based behavioral approach that involves pain-related skill acquisition and goal setting. PSM interventions have been promoted by the 2016 Department of Health and Human Services National Pain Strategy (DHHS NPS) as an effective, scalable approach to chronic pain management. Especially given the current opioid crisis, the DHHS NPS underscored the urgent need to develop and test PSM interventions tailored to the unique needs of vulnerable populations, particularly PLWH, that can be implemented and disseminated nationwide. Until an effective and scalable PSM intervention for chronic pain in PLWH is developed, reducing the burden of chronic pain safely and effectively in this population will not be possible. The overall objective of this proposal is to evaluate a novel theory-based PSM intervention, “Skills TO Manage Pain” (STOMP), developed for and tailored to PLWH. We will accomplish our overall objective with the following primary specific aim: 1) Evaluate the efficacy of STOMP, a theory-based intervention tailored to improving chronic pain in PLWH. Given our rigorous intervention development process and promising pilot trial results, our working hypothesis is that STOMP will decrease pain and improve function in PLWH. We also propose the following secondary aims: 2) Conduct exploratory analyses of the impact of STOMP on HIV outcomes associated with chronic pain (i.e. retention in care, virologic suppression), and 3) Investigate proximal outcomes as potential mediators of STOMP's impact on chronic pain. This approach is innovative because it incorporates novel peer co-led group sessions that were created based on our formative intervention development work, includes patients with comorbidities (e.g., depressive symptoms, addiction history) common among PLWH but typically excluded from chronic pain studies, and investigates the impact of a chronic pain intervention on disease-specific HIV outcomes in addition to pain and function. The proposed research will be significant because if successful, it will pave the way for future dissemination and implementation studies that have the potential to dramatically change chronic pain treatment for PLWH.

项目摘要：艾滋病病毒感染者（PLWH）慢性疼痛的行为干预是一项 研究不足的领域，具有很大的潜力，以改善疼痛和功能。慢性疼痛是一种重要的并发症 影响30%至85%的PLWH，并与更大的功能障碍几率相关， 急诊室利用率增加，艾滋病毒护理的保留不佳，以及未能实现病毒学 镇压目前尚不清楚的是如何最佳地解决这一人群的慢性疼痛。阿片类药物是 常用于治疗慢性疼痛，特别是在PLWH。治疗慢性疼痛的阿片类药物处方通常会这样做 没有导致结果的实质性改善，并导致阿片类药物成瘾日益流行 还有吸毒过量相比之下，行为干预是最有效和最安全的治疗方法之一， 慢性疼痛在普通人群中。疼痛自我管理（PSM）是一种基于社会认知理论（SCT）的 行为方法，包括疼痛相关的技能获取和目标设定。PSM的干预措施已 由2016年卫生与公众服务部国家疼痛战略（DHHS）推广，作为一项 有效、可扩展的慢性疼痛管理方法。特别是考虑到目前的阿片类药物危机，DHHS 联合国秘书长强调，迫切需要制定和测试专门针对以下群体独特需求的方案支助和管理干预措施： * 在全国范围内执行和传播易受伤害人口，特别是艾滋病毒/艾滋病感染者的方案。直到 有效和可扩展的PSM干预PLWH慢性疼痛的开发，减少慢性疼痛的负担， 在这一人群中安全有效地治疗疼痛是不可能的。本建议的总体目标是 评估一种新的基于理论的PSM干预措施，“管理疼痛的技能”（STOMP）， 到PLWH。我们将通过以下主要具体目标实现我们的总体目标：1）评估 STOMP的疗效，这是一种基于理论的干预措施，旨在改善PLWH的慢性疼痛。鉴于我们严格的 干预开发过程和有希望的试点试验结果，我们的工作假设是，STOMP将 减轻疼痛并改善PLWH的功能。我们还提出了以下次要目标：2）行为 探索性分析STOMP对与慢性疼痛相关的HIV结局的影响（即 护理，病毒学抑制），和3）调查近端结果作为STOMP影响的潜在介质 治疗慢性疼痛这种方法是创新的，因为它结合了新颖的同行共同领导的小组会议， 基于我们的形成性干预开发工作创建，包括患有合并症的患者（例如， 抑郁症状，成瘾史）在PLWH中常见，但通常被排除在慢性疼痛研究之外， 并调查了慢性疼痛干预对疾病特异性艾滋病毒结果的影响， 和功能这项拟议中的研究将具有重要意义，因为如果成功，它将为未来的研究铺平道路。 传播和实施研究，有可能大大改变慢性疼痛治疗 对于PLWH。