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

• 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
• 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

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.

项目总结/摘要 自杀是美国的主要死亡原因，2020年估计有46，000人自杀死亡。 孤独是自杀的一个人际风险因素，被认为已经达到流行病的程度， 在2019冠状病毒病大流行导致利率进一步恶化之前，鉴于 孤独感对公共健康的影响，美国国家工程院、科学院和医学院称， 卫生系统应该发挥积极作用，进行干预，以减少孤独感。初级保健是最佳的健康 系统设置提供孤独干预，以防止自杀，因为初级保健越来越多的屏幕 孤独感沿着其他健康的社会决定因素。初级保健实践也越来越多地使用 行为健康护理经理，他们可以提供孤独干预沿着抑郁治疗 和焦虑症，可能会损害从长期孤独中恢复过来，并导致自杀风险。之前 对孤独的初级保健方法有着复杂的结果，仍然没有建立，有效， 准备采用的模式，以减少孤独和自杀意念在初级保健。 本研究将采用两种孤独干预措施，社会处方和简短的认知疗法， 在初级保健中。社会处方解决了孤独的结构性决定因素（即，广度和 社会互动的频率）通过将患者与基于社区的组织或活动（例如， 志愿服务）而简短的认知疗法解决了孤独的认知决定因素（即， 关系的期望），通过教育，反思和指导练习。与先前的研究相比， 这两种干预措施都将由一名在一个 以初级保健为基础的协作保健管理方案。该项目的具体目标是：1）适应 社会处方和简短的认知治疗干预孤独的组成部分， 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开发活动将遵循ADAPT-ITT（评估、决策、管理， 生产、专题专家、整合、培训、测试）框架，并将让患者和供应商参与其中 利益攸关方为手册的编制提供信息，以指导干预措施的培训和试点测试。在Aim 2试点研究，来自两个初级保健网站的孤独和自杀意念筛查阳性的患者将 被随机分配到两种干预措施之一或EUC。在3个月时，干预的参与者 武器将接受额外3个月的替代干预，EUC参与者将继续 接收EUC。将测量可行性和可接受性，以便为未来充分把握度试验提供信息， 确定干预措施的机制和有效性，以减少孤独和自杀意念。