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一款用于紧急服务人员管理压力和创伤的智能手机版“SOLAR”的设计、开发和随机对照试验方案。

Design, development and randomised controlled trial protocol of a smartphone-delivered version of 'SOLAR' for emergency service workers to manage stress and trauma.

机构信息

Phoenix Australia, Department of Psychiatry, The University of Melbourne, Carlton, Victoria, Australia

Phoenix Australia, Department of Psychiatry, The University of Melbourne, Carlton, Victoria, Australia.

出版信息

BMJ Open. 2023 Feb 10;13(2):e062710. doi: 10.1136/bmjopen-2022-062710.

Abstract

UNLABELLED

IntroductionEmergency service workers are routinely exposed to stress and trauma, and there is a need to address mental health symptoms early to prevent chronic impairment and/or psychiatric disorder. Digital health innovations mean that face-to-face psychosocial interventions can now be delivered remotely, which is particularly appealing to populations who have strong preferences for digital delivery, such as emergency service workers. This two phase study aims to first adapt the Skills fOr Life Adjustment and Resilience (SOLAR) programme into a smartphone application ('app'), and then evaluate the effectiveness of this new app.

METHODS AND ANALYSES

First, focus groups and codesign activities with mental health professionals and emergency service workers will be conducted to develop and test the prototype smartphone version of SOLAR (ie, SOLAR-m). Second, a multicentre randomised controlled trial will investigate the effectiveness of the new app, compared with an active control app, in reducing symptoms of anxiety and depression (primary outcome), as well as other indicators of mental health and work performance. Firefighters from one of the largest urban fire and rescue services in Australia who are currently experiencing distress will be invited to participate. After screening and baseline assessment, 240 will be randomised to receive either SOLAR-m or the control app for 5 weeks, with measurements pre, post and 3-month follow-up. Analyses will be conducted within an intention-to-treat framework using mixed modelling.

ETHICS AND DISSEMINATION

The current trial has received ethics approval from the University of Melbourne Human Research Ethics Committee (2021-20632-18826-5). Study results will be disseminated through peer-reviewed journals and conferences, with a focus on how to expand the new app to other trauma-affected populations if proven effective.

TRIAL REGISTRATION NUMBER

ANZCTRN12621001141831.

摘要

目的

介绍急救服务人员经常面临压力和创伤,需要早期解决心理健康症状,以防止慢性损伤和/或精神障碍。数字健康创新意味着面对面的心理社会干预现在可以远程提供,这对于强烈偏好数字交付的人群,如急救服务人员,特别有吸引力。这项两阶段研究旨在首先将 Skills fOr Life Adjustment and Resilience (SOLAR) 计划改编为智能手机应用程序(“应用程序”),然后评估该新应用程序的有效性。

方法和分析

首先,将与心理健康专业人员和急救服务人员进行焦点小组和共同设计活动,以开发和测试 SOLAR 的原型智能手机版本(即 SOLAR-m)。其次,一项多中心随机对照试验将调查新应用程序与积极对照应用程序相比,在降低焦虑和抑郁症状(主要结果)以及其他心理健康和工作表现指标方面的有效性。澳大利亚最大的城市消防和救援服务之一的消防员目前正在经历困境,将被邀请参加。在筛选和基线评估后,将随机分配 240 名参与者接受 SOLAR-m 或对照应用程序治疗 5 周,在治疗前、治疗后和 3 个月随访时进行测量。分析将在意向治疗框架内使用混合模型进行。

伦理和传播

目前的试验已获得墨尔本大学人类研究伦理委员会的伦理批准(2021-20632-18826-5)。研究结果将通过同行评议的期刊和会议传播,重点是如果新应用程序被证明有效,如何将其扩展到其他受创伤影响的人群。

试验注册号

ANZCTRN12621001141831。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f51d/9923250/a92d8cdb6bf2/bmjopen-2022-062710f01.jpg

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