Melia Ruth, Francis Kady, Duggan Jim, Bogue John, O'Sullivan Mary, Young Karen, Chambers Derek, McInerney Shane J, O'Dea Edmond, Bernert Rebecca
Department of Psychology, University of Limerick, Limerick, Ireland.
School of Psychology, University of Galway, Galway, Ireland.
JMIR Res Protoc. 2023 Feb 21;12:e44205. doi: 10.2196/44205.
Over 700,000 people die by suicide annually, making it the fourth leading cause of death among those aged 15-29 years globally. Safety planning is recommended best practice when individuals at risk of suicide present to health services. A safety plan, developed in collaboration with a health care practitioner, details the steps to be taken in an emotional crisis. SafePlan, a safety planning mobile app, was designed to support young people experiencing suicidal thoughts and behaviors and to record their plan in a way that is accessible immediately and in situ.
The aim of this study is to assess the feasibility and acceptability of the SafePlan mobile app for patients experiencing suicidal thoughts and behaviors and their clinicians within Irish community mental health services, examine the feasibility of study procedures for both patients and clinicians, and determine if the SafePlan condition yields superior outcomes when compared with the control condition.
A total of 80 participants aged 16-35 years accessing Irish mental health services will be randomized (1:1) to receive the SafePlan app plus treatment as usual or treatment as usual plus a paper-based safety plan. The feasibility and acceptability of the SafePlan app and study procedures will be evaluated using both qualitative and quantitative methodologies. The primary outcomes are feasibility outcomes and include the acceptability of the app to participants and clinicians, the feasibility of delivery in this setting, recruitment, retention, and app use. The feasibility and acceptability of the following measures in a full randomized controlled trial will also be assessed: the Beck Scale for Suicide Ideation, Columbia Suicide Severity Rating Scale, Coping Self-Efficacy Scale, Interpersonal Needs Questionnaire, and Client Service Receipt Inventory. A repeated measures design with outcome data collected at baseline, post intervention (8 weeks), and at 6-month follow-up will be used to compare changes in suicidal ideation for the intervention condition relative to the waitlist control condition. A cost-outcome description will also be undertaken. Thematic analyses will be used to analyze the qualitative data gathered through semistructured interviews with patients and clinicians.
As of January 2023, funding and ethics approval have been acquired, and clinician champions across mental health service sites have been established. Data collection is expected to commence by April 2023. The submission of completed manuscript is expected by April 2025.
The framework for Decision-making after Pilot and feasibility Trials will inform the decision to progress to a full trial. The results will inform patients, researchers, clinicians, and health services of the feasibility and acceptability of the SafePlan app in community mental health services. The findings will have implications for further research and policy regarding the broader integration of safety planning apps.
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每年有超过70万人死于自杀，这使其成为全球15至29岁人群中的第四大死因。当有自杀风险的个体前往医疗服务机构时，安全计划被推荐为最佳实践。安全计划是与医疗从业者合作制定的，详细说明了在情绪危机中应采取的步骤。SafePlan是一款安全计划移动应用程序，旨在支持有自杀想法和行为的年轻人，并以一种可即时现场获取的方式记录他们的计划。
本研究的目的是评估SafePlan移动应用程序在爱尔兰社区心理健康服务中对于有自杀想法和行为的患者及其临床医生的可行性和可接受性，检验患者和临床医生研究程序的可行性，并确定与对照条件相比，SafePlan条件是否能产生更好的结果。
共有80名年龄在16至35岁之间、接受爱尔兰心理健康服务的参与者将被随机分组（1:1），以接受SafePlan应用程序加常规治疗或常规治疗加纸质安全计划。将使用定性和定量方法评估SafePlan应用程序和研究程序的可行性和可接受性。主要结果是可行性结果，包括应用程序对参与者和临床医生的可接受性、在该环境中实施的可行性、招募、留存率和应用程序使用情况。还将评估在全面随机对照试验中以下测量方法的可行性和可接受性：贝克自杀意念量表（Beck Scale for Suicide Ideation）、哥伦比亚自杀严重程度评定量表（Columbia Suicide Severity Rating Scale）、应对自我效能量表（Coping Self-Efficacy Scale）、人际需求问卷（Interpersonal Needs Questionnaire）和客户服务接受清单（Client Service Receipt Inventory）。将采用重复测量设计，在基线、干预后（8周）和6个月随访时收集结果数据，以比较干预组与等待名单对照组在自杀意念方面的变化。还将进行成本-结果描述。主题分析将用于分析通过对患者和临床医生进行半结构化访谈收集的定性数据。
截至2023年1月，已获得资金和伦理批准，并在各心理健康服务站点设立了临床倡导者。预计数据收集将于2023年4月开始。预计将于2025年4月提交完整的手稿。
试点和可行性试验后的决策框架将为推进全面试验的决策提供依据。研究结果将向患者、研究人员、临床医生和卫生服务机构通报SafePlan应用程序在社区心理健康服务中的可行性和可接受性。研究结果将对安全计划应用程序更广泛整合的进一步研究和政策产生影响。
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