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: 9922384
• 负责人: Jessica S Merlin
• 金额: $ 61.03万
• 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 2023-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9922384
• 关键词: Academy; Accident and Emergency department; Acquired Immunodeficiency Syndrome; Address; Affect; Area; Behavior Therapy; Behavioral; Behavioral trial; Caring; Clinical; Collaborations; Disease; 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; 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; emotional functioning; expectation; experience; functional disability; healing; improved; improved functioning; innovation; mortality risk; novel; opioid epidemic; opioid overdose; 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; virology

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：针对艾滋病毒感染者 (PLWH) 慢性疼痛的行为干预是一项 尚未研究的领域，具有改善疼痛和功能的巨大潜力，是一种重要的合并症。 影响 30% 至 85% 的 PLWH，并且与功能障碍的可能性更大有关， 急诊室利用率增加、艾滋病毒护理保留不理想以及未能实现病毒学检测 目前尚不清楚如何最佳地解决这一人群的慢性疼痛。 慢性疼痛的常用治疗方法，特别是用于治疗慢性疼痛的阿片类药物通常会起到作用。 不会导致结果的实质性改善，并导致阿片类药物成瘾日益流行 相比之下，行为干预是最有效和最安全的治疗方法之一。 普通人群的慢性疼痛是一种基于社会认知理论（SCT）的疼痛自我管理（PSM）。 涉及疼痛相关技能获取和目标设定的行为方法已被采用。 2016 年卫生与公众服务部国家疼痛战略 (DHHS NPS) 提倡将其作为 特别是考虑到当前的阿片类药物危机，DHHS 制定了有效、可扩展的慢性疼痛管理方法。 NPS 强调迫切需要开发和测试针对特定人群独特需求的 PSM 干预措施 弱势群体，特别是艾滋病病毒感染者，可以在全国范围内实施和传播。 针对 PLWH 的慢性疼痛开发了有效且可扩展的 PSM 干预措施，减轻了慢性疼痛的负担 在这一人群中安全有效地疼痛是不可能的。该提案的总体目标是 评估基于理论的新型 PSM 干预措施“管理疼痛的技能”(STOMP)，该干预措施是为 我们将通过以下主要具体目标来实现我们的总体目标： 1) 评估 鉴于我们严格的要求，STOMP 是一种基于理论的干预措施，旨在改善 PLWH 的慢性疼痛。 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 减少 PLWH 的疼痛并改善功能。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 3) 研究近期结果作为 STOMP 影响的潜在中介 这种方法是创新的，因为它结合了新颖的同伴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，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， 并研究除了疼痛之外，慢性疼痛干预对特定疾病的艾滋病毒结果的影响 拟议的研究将具有重要意义，因为如果成功，它将为未来铺平道路。 有可能极大改变慢性疼痛治疗的传播和研究 对于艾滋病患者。