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Development and Pilot Study of Primary Care Loneliness Interventions to Prevent Suicide

预防自杀的初级保健孤独干预措施的开发和试点研究

基本信息

批准号：
10646959
负责人：
Paul Nelson Pfeiffer
金额：
$ 23.4万
依托单位：
UNIVERSITY OF MICHIGAN AT ANN ARBOR
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-07-15 至 2026-05-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10646959
关键词：
Academy Acceleration Address Adopted Adult Anxiety Anxiety Disorders Behavior Therapy COVID-19 pandemic Caring Case Manager Cause of Death Chronic Clinic Clinical Cognitive Cognitive Therapy Collaborations Communities Development Education Effectiveness Effectiveness of Interventions Eligibility Determination Engineering Enrollment Epidemic Exercise Feeling suicidal Frequencies Future Health Services Health system Hybrids Impairment Intervention Investigational Therapies Lead Link Loneliness Managed Care Managed Care Programs Manuals Measures Medicare Medicine Mental Depression Mental Health Meta-Analysis Modeling Outcome Participant Patients Pharmacotherapy Pilot Projects Prevalence Primary Care Production Protocols documentation Provider Psychiatry Public Health Randomized Recovery Research Risk Factors Role Science Services Site Social Interaction Social isolation Suicide Suicide prevention Surgeon Testing Therapeutic Intervention Time Training acceptability and feasibility arm behavioral health collaborative care community organizations comorbid depression design effectiveness evaluation effectiveness trial expectation experience follow up assessment health care settings health related quality of life implementation/effectiveness improved innovation lonely individuals mortality patient engagement patient response pilot test primary care clinic primary care practice primary care provider primary outcome reducing suicide secondary outcome social social engagement social health determinants structural determinants suicidal behavior suicidal morbidity suicidal risk three-arm trial tool treatment arm treatment as usual volunteer

项目摘要

Project Summary/Abstract Suicide is a leading cause of death in the US with an estimated 46,000 suicide deaths occuring in 2020. Loneliness, an interpersonal risk factor for suicide, was recognized as having reached epidemic proportions by the US Surgeon General in 2017 before rates further worsened due to the COVID-19 pandemic. Given the public health impact of loneliness, the National Academies of Engineering, Sciences, and Medicine have called for health systems to take an active role and intervene to reduce loneliness. Primary care is the optimal health system setting to deliver loneliness interventions to prevent suicide because primary care increasingly screens for loneliness along with other social determinants of health. Primary care practices also increasingly employ behavioral health care managers who can deliver loneliness interventions along with treatments for depression and anxiety disorders that may impair recovery from chronic loneliness and contribute to suicide risk. Prior primary care approaches to loneliness have had mixed results and there remains no established, effective, ready-to-adopt model to reduce loneliness and suicidal ideation in primary care. This study will adapt two loneliness interventions, social prescribing and brief cognitive therapy, to be delivered within primary care. Social prescribing addresses the structural determinants of loneliness (i.e., breadth and frequency of social interactions) by linking patients to community-based organizations or activities (e.g., volunteering) whereas brief cognitive therapy addresses the cognitive determinants of loneliness (i.e., relationship expectations) through education, reflections, and guided exercises. In contrast to prior studies, both interventions will be adapted to be delivered by a behavioral health care manager working within a primary care-based collaborative care management program. The specific aims of the project are: 1) Adapt social prescribing and brief cognitive therapy interventions for loneliness to be delivered as components of primary care collaborative care management and 2) conduct a randomized controlled pilot study (N=60) to determine feasibility and acceptability of the two interventions and trial protocols. The Aim 1 development activities will be guided by the ADAPT-ITT (assessment, decision, administration, production, topical experts, integration, training, testing) framework and will engage patient and provider stakeholders to inform production of manuals to guide training and pilot testing of the interventions. In the Aim 2 pilot study, patients from two primary care sites who screen positive for loneliness and suicidal ideation will be randomly assigned to one of the two interventions or to EUC. At 3 months, participants in the intervention arms will receive the alternate intervention for an additional 3 months, and EUC participants will continue to receive EUC. Feasibility and acceptability will be measured to inform a future adequately powered trial to determine the interventions’ mechanisms and effectiveness for reducing loneliness and suicidal ideation.

项目概要/摘要自杀是美国的主要原因，2020 年估计有 46,000 人自杀死亡。孤独是自杀的人际风险因素，被认为已达到流行的程度 2017 年，美国卫生局局长曾就职于美国卫生局局长，之后由于 COVID-19 大流行，死亡率进一步恶化。鉴于美国国家工程院、科学院和医学院呼吁孤独感对公共健康的影响卫生系统应发挥积极作用并进行干预，以减少孤独感。初级保健是最佳健康由于初级保健越来越多地进行筛查，因此系统设置提供孤独干预措施以防止自杀孤独感以及其他健康的社会决定因素。初级保健实践也越来越多地采用行为健康护理管理者可以提供孤独干预措施以及抑郁症治疗和焦虑症可能会损害从长期孤独中恢复并增加自杀风险。事先的应对孤独感的初级保健方法的结果好坏参半，而且仍然没有既定的、有效的、准备采用的模型可减少初级保健中的孤独感和自杀意念。这项研究将采用两种孤独干预措施，即社会处方和简短的认知疗法。在初级保健范围内。社会处方解决了孤独感的结构性决定因素（即孤独感的广度和程度）。通过将患者与社区组织或活动（例如，志愿服务）而简短的认知疗法则解决孤独感的认知决定因素（即关系期望）通过教育、反思和指导练习。与之前的研究相比，这两种干预措施都将由在一个机构内工作的行为健康护理经理来实施。基于初级保健的协作护理管理计划。该项目的具体目标是： 1) 适应针对孤独感的社会处方和简短的认知治疗干预措施将作为初级保健协作护理管理和 2) 进行随机对照试点研究 (N=60) 确定两种干预措施和试验方案的可行性和可接受性。目标 1 开发活动将由 ADAPT-ITT（评估、决策、管理、生产、主题专家、集成、培训、测试）框架，并将吸引患者和提供者参与利益相关者告知手册的制作，以指导干预措施的培训和试点测试。在目标中 2 试点研究中，来自两个初级保健机构的孤独感和自杀意念筛查结果呈阳性的患者将出现被随机分配到两种干预措施之一或 EUC。 3 个月时，干预参与者手臂将接受额外 3 个月的替代干预，并且 EUC 参与者将继续接收 EUC。将衡量可行性和可接受性，以便为未来的充分动力试验提供信息确定减少孤独感和自杀意念的干预措施的机制和有效性。