Black Dog Institute, University of New South Wales, Sydney, New South Wales, Australia.
School of Psychology, Western Sydney University, Sydney, New South Wales, Australia.
BMJ Open. 2022 May 30;12(5):e058584. doi: 10.1136/bmjopen-2021-058584.
Youth suicidal ideation and behaviour is concerning due to its widespread prevalence, morbidity and potentially fatal consequences. Digital mental health interventions have been found to improve access to low-cost and high-quality support for a range of mental health issues, yet there are few digital interventions available for suicide prevention in young people. In addition, no studies have examined how digital engagement strategies may impact the engagement and efficacy of digital interventions in suicide prevention. The current protocol describes a three-arm parallel randomised controlled trial. A therapeutic smartphone application ('LifeBuoy'; intervention condition) will be tested against a condition that consists of the LifeBuoy application plus access to a digital engagement strategy ('LifeBuoy+engagement'; intervention condition) to determine whether the addition of the digital strategy improves app engagement metrics. To establish the efficacy of the LifeBuoy application, both of these intervention conditions will be tested against an attention-matched control condition (a placebo app).
669 young Australians aged 17-24 years who have experienced suicidal ideation in the past 30 days will be recruited by Facebook advertisement. The primary outcomes will be suicidal ideation severity and level of app engagement. Primary analyses will use an intention-to-treat approach and compare changes from baseline to 30-day, 60-day and 120-day follow-up time points relative to the control group using mixed-effect modelling. A subset of participants in the intervention groups will be interviewed on their experience with the app and engagement strategy. Qualitative data will be analysed using an inductive approach, independent of a theoretical confirmative method to identify the group themes.
The study has been approved by the University of New South Wales Human Research Ethics Committee (HC210400). The results of the trial will be disseminated via peer-reviewed publications in scientific journals and conferences.
ACTRN12621001247864.
由于青少年自杀意念和行为的普遍存在、发病率和潜在的致命后果，这令人担忧。数字心理健康干预措施已被发现可改善获得低成本、高质量的各种心理健康问题支持的机会，但针对年轻人预防自杀的数字干预措施却很少。此外，目前还没有研究探讨数字参与策略如何影响数字干预在预防自杀方面的参与度和效果。本研究方案描述了一项三臂平行随机对照试验。一种治疗性智能手机应用程序（“救生圈”；干预条件）将与一种包含“救生圈”应用程序加获得数字参与策略的条件（“救生圈+参与”；干预条件）进行比较，以确定数字策略的添加是否能提高应用程序的参与度指标。为了确定“救生圈”应用程序的疗效，将这两种干预条件都与一个注意力匹配的对照组（安慰剂应用程序）进行比较。
将通过 Facebook 广告招募 669 名过去 30 天内有过自杀意念的 17-24 岁澳大利亚年轻人。主要结局指标将是自杀意念严重程度和应用程序参与度。主要分析将采用意向治疗方法，并使用混合效应模型比较相对于对照组，从基线到 30 天、60 天和 120 天随访时间点的变化。干预组的一部分参与者将接受关于应用程序和参与策略的体验访谈。定性数据将采用归纳方法进行分析，独立于理论验证方法，以确定群体主题。
该研究已获得新南威尔士大学人类研究伦理委员会（HC210400）的批准。试验结果将通过同行评议的科学期刊和会议论文发表。
ACTRN12621001247864。
