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：艾滋病毒（PLWH）患者中慢性疼痛的行为干预是一种 研究的区域，具有改善疼痛和功能的巨大潜力。慢性疼痛是重要的合并症 这会影响PLWH的30％至85％，并且与功能障碍的几率有关， 急诊室利用率增加，在艾滋病毒护理中的次优率以及未能实现病毒学性 抑制。尚不清楚的是如何在该人群中最佳解决慢性疼痛。阿片类药物是 通常用于慢性疼痛的治疗，尤其是在PLWH中。慢性疼痛的阿片类药物处方通常 不会导致结局的大幅改善，并导致阿片类药物成瘾的流行病 和用药过量。相反，行为干预是最有效，最安全的治疗方法之一 普通人群的慢性疼痛。疼痛自我管理（PSM）是基于社会认知理论（SCT） 行为方法涉及与疼痛相关的技能获取和目标设定。 PSM干预措施已经 由2016年卫生与公共服务部国家疼痛战略（DHHS NP）推广为 有效的，可扩展的慢性疼痛管理方法。特别是考虑到当前的阿片类药物危机，DHHS NP强调了针对根据独特需求而制定的开发和测试PSM干预措施的迫切需求 可以在全国范围内实施和传播的脆弱人群，尤其是PLWH。直到一个 开发了有效且可扩展的PSM慢性疼痛的PSM干预，从而减少了慢性的燃烧 在这个人群中安全有效的疼痛是不可能的。该提议的总体目的是 评估一种基于理论的新型PSM干预措施，“管理疼痛的技能”（Stomp），为量身定制和量身定制 到plwh。我们将以以下主要目的来实现我们的整体目标：1）评估 Stomp的功效，这是一种基于理论的干预措施，该干预措施是针对改善PLWH慢性疼痛的。考虑到我们的严格 干预开发过程和有前途的试验结果，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结果的影响（即保留 护理，病毒学抑制）和3）研究近端结果作为Stomp的潜在介体 关于慢性疼痛。这种方法具有创新性，因为它结合了新颖的同行共同领导的小组会议 根据我们的形成性干预开发工作创建的，包括合并症的患者（例如， 抑郁症状，成瘾病史）在PLWH中常见，但通常被排除在慢性疼痛研究之外， 并研究了慢性疼痛干预对疾病特异性艾滋病毒预后的影响 和功能。拟议的研究将是重要的，因为如果成功，它将为未来铺平道路 传播和实施研究可能会大大改变慢性疼痛治疗 对于PLWH。