A Mobile Intervention for Suicide Prevention For Middle-aged And Older Adults After a Suicide-Related Hospitalization

中老年人因自杀住院后预防自杀的移动干预

• 批准号: 10559578
• 负责人: DIMITRIS N KIOSSES
• 金额: $ 77.87万
• 依托单位: WEILL MEDICAL COLL OF CORNELL UNIV
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-02-01 至 2025-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10559578
• 关键词: Admission activity; Affect; Age; Blinded; Characteristics; Charge; Clinical; Clinical Trials; Data; Educational Materials; Elderly; Emotional; Emotions; Evaluation; Exclusion Criteria; Family; Feeling suicidal; Goals; Hospitalization; Hospitals; Inpatients; Intervention; Interviewer; Link; Loneliness; Measures; Mental Depression; Modeling; National Institute of Mental Health; Outcome; Participant; Patient Self-Report; Patients; Persons; Phase; Population; Population Intervention; Populations at Risk; Prevention; Psychotherapy; Questionnaires; Randomized; Research Assistant; Sampling; Schedule; Severities; Signal Transduction; Social Workers; Suicide; Suicide attempt; Suicide prevention; Tablets; Techniques; Testing; Text; Training; Update; acceptability and feasibility; attentional control; cognitive control; cognitive reappraisal; dosage; emotion regulation; high risk; high risk population; improved; innovation; instrument; meetings; member; middle age; novel; perceived stress; psychosocial; reducing suicide; sex; stressor; suicidal behavior; suicidal risk; suicide rate; telecoaching; therapy design; treatment as usual; usual care arm; virtual

ABSTRACT The goal of this project is to refine and test WellPATH-PREVENT, a novel, mobile, principally stand-alone psychosocial intervention designed to improve cognitive reappraisal ability (target) and reduce suicide risk (outcome) in middle-aged and older adults (50-90 years old) who have been discharged after a suicide-related hospitalization (i.e. for suicidal ideation or suicide attempt). Suicide rates in this group are alarmingly high, and reducing suicide rates in at-risk populations is a major NIMH priority. Our conceptual framework views suicidal ideation and behavior as failed attempts to regulate negative emotions, and by improving cognitive reappraisal, an effective emotion regulation strategy, we expect to reduce suicide risk. WellPATH-PREVENT focuses on the training, coaching, and use of WellPATH app, a tablet-app that incorporates triggers, negative emotions, and personalized easy-to-use cognitive reappraisal techniques. The patient uses the tablet during emotionally charged situations and scheduled training sessions. The R61 phase is a proof-of-concept phase and its goals are to test WellPATH-PREVENT’s target engagement and optimization (6 vs. 12 weeks duration). Interventionists will administer WellPATH-PREVENT to 40 middle-aged and older adults (50-90 years old) after a suicide-related hospitalization. Research assistants, unaware of the study aims, will conduct assessments at study entry (admission/during hospitalization), discharge, 6 and 12 weeks post-discharge. Target engagement will be assessed with electrocortical measures (i.e. late positive potential, LPP), self-reported affect during an emotion regulation task, and Emotion Regulation Questionnaire (ERQ), an interviewer-administered instrument of cognitive reappraisal. The R33 phase aims to provide further evidence of target engagement of the optimized WellPATH- PREVENT in a larger sample, evaluate the relationship of cognitive reappraisal with suicide risk as measured with Columbia Suicide Severity Rating Scale (C-SSRS), examine preliminary signal of efficacy, and obtain implementation parameters for a large-scale clinical trial. A unique sample of 75 middle-aged and older adults (using the same inclusion/exclusion criteria as for the R61 phase) will be randomized (2 to 1) to WellPATH- PREVENT (N=50) or to Attention Control Usual Care (AC-UC) (a control condition with parallel delivery and a tablet that doesn’t include WellPATH) (N=25). Assessments will be conducted at study entry (admission/during hospitalization), discharge, 6, 12 and 24 weeks post-discharge. Primary aims are: 1) WellPATH-PREVENT participants will show improvement in cognitive reappraisal from discharge to end of treatment; 2) improvement in cognitive reappraisal in WellPATH-PREVENT participants will be associated with suicide risk over 24 weeks; and 3) examination of preliminary signal of efficacy of WellPATH-PREVENT vs. AC-UC on cognitive reappraisal and on suicide risk over 24 weeks.

摘要 这个项目的目标是完善和测试WellPATH-PREVENT，一个新颖的，移动的，主要是独立的 旨在提高认知再评价能力（目标）和降低自杀风险的心理社会干预 （结果）在中年和老年人（50-90岁）谁已经出院后，自杀相关的 住院治疗（即自杀意念或自杀企图）。这一群体的自杀率高得惊人， 降低高危人群的自杀率是NIMH的主要优先事项。 我们的概念框架将自杀意念和行为视为调节消极情绪的失败尝试。 情绪，并通过改善认知重新评价，一种有效的情绪调节策略，我们希望 降低自杀风险。WellPATH-PREVENT专注于WellPATH应用程序的培训，指导和使用， 平板电脑应用程序，包含触发器，负面情绪和个性化的易于使用的认知重新评估 技术.患者在情绪激动的情况下和预定的训练课程中使用平板电脑。 R61阶段是概念验证阶段，其目标是测试WellPATH-PREVENT的目标 参与和优化（6周vs. 12周）。介入医生将给予WellPATH-PREVENT 40名中年和老年人（50-90岁）在自杀相关住院后。研究 不了解研究目的的助理将在研究入组时（入组/期间）进行评估 住院）、出院、出院后6周和12周。目标参与度将通过以下方式进行评估： 皮层电测量（即晚期正电位，LPP），情绪调节期间的自我报告影响 任务，情绪调节问卷（ERQ），一个面试官管理的认知工具， 重新评估 R33阶段旨在提供优化WellPATH目标接合的进一步证据- 在更大的样本中，评估认知重新评估与自杀风险的关系， 采用哥伦比亚自杀严重程度评定量表（C-SSRS），检查疗效的初步信号，并获得 大规模临床试验的实施参数。一个由75名中年和老年人组成的独特样本 （使用与R61期相同的入选/排除标准）将随机（2比1）分配至WellPATH- 预防（N=50）或注意力控制精神护理（AC-UC）（一种平行分娩的对照条件， 不包括WellPATH的片剂）（N=25）。评估将在研究入组时进行（入组/期间 住院）、出院、出院后6、12和24周。主要目标是：1）井径预防 从出院到治疗结束，参与者的认知再评价将有所改善; 2）改善 WellPATH-PREVENT参与者的认知重新评估将与24周内的自杀风险相关; 和3）检查WellPATH-PREVENT相对于AC-UC对认知功能的功效的初步信号 重新评估和自杀风险超过24周。