Addressing Loneliness in Primary Care Patients on Chronic Opioids to Prevent Opioid Misuse

项目总结 服用阿片类药物的慢性疼痛患者经常经历孤独，这与较贫穷有关 阿片类药物滥用和阿片类药物使用障碍的健康后果和更高风险。鉴于几乎一半的阿片类药物 在初级保健中规定，迫切需要制定和测试干预措施，以减少 初级保健患者存在阿片类药物滥用风险的孤独感。我们研究的长期目标是减少阿片类药物 通过解决长期服用阿片类药物的初级保健患者的孤独感，解决滥用和阿片类药物使用障碍。 认知行为疗法对适应不良社会认知的干预及改善 通过社交导航获得的社会支持在减少孤独感和改善生活质量方面被证明是有效的 在其他领域的结果，但尚未在有药物使用障碍风险的患者中进行测试。 在我们的研究中，响应了RFA-DA-23-010(增强社会连接性和改善 为了预防和治疗SUD并支持康复)，我们提出了一个试点的三臂随机临床试验 将适应和测试实施两种有效干预措施的可行性的有效性试验：(1) 使用认知行为疗法进行心理干预以解决周围的不适应思维模式 社交联系和(2)社交导航干预，将参与者与社交机会和 发展支持性的社交网络。我们建议的研究将在初级保健实践中进行， 华盛顿、怀俄明州、阿拉斯加、蒙大拿州和爱达荷州地区实践与研究网络，以实践为基础 拥有100多项实践的研究网络。我们的具体目标是：(1)完善和适应社会 参与导航和心理孤独感干预对慢性阿片类药物初级护理患者的影响 患者和临床医生参加一系列利益相关者小组会议，(2)评估实施 使用RE-AIM框架对102名患者进行的3-ARM随机临床疗效试验，以及(3) 确定中介结果(孤独感)、主要结果(阿片类药物)的分布和变异性 误用)和二次结果，包括阿片类药物剂量、功能状态和患者报告的疼痛 时间点--基线、干预后和干预后3个月。 我们的研究具有创新性，因为我们正在测试针对患者孤独感的循证干预措施 阿片类药物滥用的风险很高，因为他们已经在接受治疗，而且大多数患者患有慢性疼痛 接受他们与疼痛相关的护理。我们期望，根据R34机制的宗旨，该项目 将使我们为更大规模的实用试验做好准备，在这种试验中，我们可以利用嵌入式或远程行为健康 在不同的初级保健实践中的专业人员，测试患者的结果，临床层面的可行性， 和可持续性。该项目预计将对减少阿片类药物滥用产生积极影响，并有可能 发展物质使用障碍，以及改善健康结果、功能和生活质量。

PROJECT SUMMARY Patients with chronic pain on opioids frequently experience loneliness, which is associated with poorer health outcomes and higher risks for opioid misuse and opioid use disorder. Given that almost half of opioids are prescribed in primary care, a critical need exists for the development and testing of interventions to reduce loneliness in primary care patients at risk for opioid misuse. The long-term goal of our study is to reduce opioid misuse and opioid use disorder by addressing loneliness in primary care patients on chronic opioids. Interventions addressing maladaptive social cognition through cognitive behavioral therapy and improving social support through social navigation have been shown to be effective in reducing loneliness and improving outcomes in other fields but have not been tested in patients at risk for substance use disorder. In our study, which responds to RFA-DA-23-010 (Enhancing Social Connectedness and Ameliorating Loneliness to Prevent and Treat SUD and Support Recovery), we propose a pilot 3-arm randomized clinical effectiveness trial that will adapt and test the feasibility of implementing two efficacious interventions: (1) a psychological intervention using cognitive behavioral therapy to address maladaptive thought patterns around social connection and (2) a social navigation intervention to connect participants with social opportunities and develop supportive social networks. Our proposed study would take place in primary care practices from the Washington, Wyoming, Alaska, Montana and Idaho region Practice and Research Network, a practice-based research network of over 100 practices. Our specific aims are: (1) to refine and adapt both the social navigation and psychological loneliness interventions for primary care patients on chronic opioids by engaging patients and clinicians in a series of stakeholder group meetings, (2) to assess the feasibility of implementing a 3-arm randomized clinical effectiveness trial with 102 patients using the RE-AIM framework, and (3) to determine the distribution and variability in the mediating outcome (loneliness), the primary outcome (opioid misuse) and secondary outcomes including opioid dose, functional status and patient-reported pain at three time points -- baseline, post-intervention and 3 months post-intervention. Our study is innovative because we are testing evidence-based interventions for loneliness in patients at high risk for opioid misuse where they are already receiving care and where most patients with chronic pain receive their pain related care. We expect that, consistent with the purpose of the R34 mechanism, this project will prepare us for larger scale pragmatic trial, where we can leverage embedded or remote behavioral health professionals within a diverse set of primary care practices, that tests patient outcomes, clinic-level feasibility, and sustainability. The project is expected to have a positive impact in reducing opioid misuse and potentially development of substance use disorder, as well as improve health outcomes, functionality, and quality of life.