Adherence and efficacy outcomes in young Australians with suicidal ideation using a self-management app and digital engagement strategy compared with a sham app: a three-arm randomised controlled trial.

IF 9.6 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL EClinicalMedicine Pub Date : 2024-12-06 eCollection Date: 2025-01-01 DOI:10.1016/j.eclinm.2024.102963
Michelle Torok, Lauren McGillivray, Daniel Z Q Gan, Jin Han, Sarah Hetrick, Quincy J J Wong
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Abstract

Background: Digital interventions are important treatment solutions for suicidal ideation, but premature disengagement is a significant threat to their effectiveness. We tested the adherence to, and efficacy of, two versions of an app-based intervention (app only, app + engagement strategy) for suicidal ideation, compared to a sham app.

Methods: This was an online double-blind, three-arm parallel randomised controlled trial in Australia. Recruitment occurred between May 30 and August 8, 2023 and eligible participants were aged 17-24 years and had suicidal ideation in the prior 30 days. They were randomly assigned 1:1:1 to receive (i) LifeBuoy-an app which delivered third wave cognitive behavioural therapy (CBT) skills, (ii) the LifeBuoy app plus a digital engagement strategy, or (iii) a sham app to minimise expectancy bias. The primary efficacy outcome was change in suicidal ideation scores, measured by the Suicidal Ideation Attributes Scale (SIDAS), at 30-, 60- and 120- days post-baseline. The primary engagement outcome was the number of app modules completed at 60-days post-baseline. The final assessment occurred on December 6, 2023. All data was analysed using intention-to-treat. This trial was registered at anzctr.org.au, trial number: ACTRN12621001247864.

Findings: 692 participants were assigned (mean age: 19.9 [SD 2.5]; 70% female; intervention (combined): n-459, control: n-233). Significant reductions in ideation scores were observed in the combined intervention condition at 60- (d 0.48) and 120- (d 0.29) days after random assignment compared to the control condition. There were no differences in the number of modules completed between the intervention conditions (OR 1.10, 1.03, respectively) and no significant differences in their ideation scores at any time (ds -0.15 to 0.08). Serious adverse events (hospital presenting non-suicidal self-harm and/or suicide attempts) were reported by 6% of participants during the trial (control condition: 9%; combined intervention condition: 4%). No deaths were reported.

Interpretation: A third wave CBT app helped to reduce ideation severity, however providing additional online resources to promote therapeutic engagement did not enhance these effects.

Funding: This trial and MT was funded by the National Health & Medical Research Council, Matana Foundation for Young People, Alex Roth Foundation.

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有自杀意念的澳大利亚年轻人使用自我管理应用程序和数字参与策略与假应用程序的依从性和疗效结果:一项三组随机对照试验。
背景:数字干预是自杀意念的重要治疗方案,但过早脱离是其有效性的重大威胁。我们测试了两种版本的基于应用程序的自杀意念干预(仅应用程序,应用程序+参与策略)的依从性和有效性,并与假应用程序进行了比较。方法:这是一项在澳大利亚进行的在线双盲,三臂平行随机对照试验。招募时间为2023年5月30日至8月8日,符合条件的参与者年龄为17-24岁,在过去30天内有自杀意念。他们以1:1:1的比例随机分配,接受(i) LifeBuoy——一款提供第三波认知行为疗法(CBT)技能的应用程序,(ii) LifeBuoy应用程序加上数字参与策略,或(iii)一个虚假应用程序,以尽量减少预期偏差。主要疗效指标是自杀意念评分的变化,由自杀意念属性量表(SIDAS)测量,在基线后30、60和120天。用户粘性的主要结果是在基线后60天内完成的应用模块数量。最终评估发生在2023年12月6日。使用意向治疗法分析所有数据。本试验注册在anzctr.org.au,试验号:ACTRN12621001247864。结果:692名参与者被分配(平均年龄:19.9岁[SD 2.5];70%的女性;干预(联合):n-459,对照组:n-233。与对照组相比,在随机分配后60天(d 0.48)和120天(d 0.29),联合干预条件下的思维评分显著降低。不同干预条件下完成的模块数差异无统计学意义(OR分别为1.10、1.03),任何时间的思维得分差异无统计学意义(ds为-0.15 ~ 0.08)。在试验期间,6%的参与者报告了严重不良事件(医院表现为非自杀性自残和/或自杀企图)(对照条件:9%;联合干预条件:4%)。没有死亡报告。解释:第三波CBT应用程序有助于降低意念严重程度,然而提供额外的在线资源来促进治疗参与并没有增强这些效果。资助:这项试验和MT由国家卫生与医学研究委员会、马塔纳青年基金会、亚历克斯罗斯基金会资助。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
EClinicalMedicine
EClinicalMedicine Medicine-Medicine (all)
CiteScore
18.90
自引率
1.30%
发文量
506
审稿时长
22 days
期刊介绍: eClinicalMedicine is a gold open-access clinical journal designed to support frontline health professionals in addressing the complex and rapid health transitions affecting societies globally. The journal aims to assist practitioners in overcoming healthcare challenges across diverse communities, spanning diagnosis, treatment, prevention, and health promotion. Integrating disciplines from various specialties and life stages, it seeks to enhance health systems as fundamental institutions within societies. With a forward-thinking approach, eClinicalMedicine aims to redefine the future of healthcare.
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