针对丧亲父母的长期悲痛的移动应用程序:一项随机对照试验的研究方案。
Mobile app for prolonged grief among bereaved parents: study protocol for a randomised controlled trial.
机构信息
Department of Neuroscience, Uppsala University, Uppsala, Sweden
Department of Clinical Psychology and Experimental Psychopathology, University of Groningen, Groningen, The Netherlands.
出版信息
BMJ Open. 2021 Dec 7;11(12):e052763. doi: 10.1136/bmjopen-2021-052763.
INTRODUCTION
Bereaved parents, who have lost a child, have an elevated risk to develop mental health problems, yet, few studies have evaluated the effect of psychosocial interventions developed for bereaved parents. Cognitive-behavioural therapy (CBT), both face to face or digitally delivered, has shown to be an effective intervention for prolonged grief symptoms. Self-help mobile apps offer various advantages and studies show improved mental health after app interventions. No app has yet been evaluated targeting prolonged grief in bereaved parents. Therefore, the aim of this planned study is to develop and examine the effectiveness of a CBT-based mobile app, called in reducing symptoms of prolonged grief, as well as other psychological symptoms, in bereaved parents. Another aim is to assess users' experiences and adverse events of .
METHODS AND ANALYSIS
We will conduct a two-armed randomised waitlist-controlled trial. Parents living in Sweden, who lost a child between one and ten years ago, with elevated symptoms of prolonged grief, will be recruited to participate in the trial. The content of covers four main domains (Learn; Self-monitoring; Exercises; Get support) and builds on principles of CBT and the proven-effective app. Participants in the intervention group will fill out online questionnaires at baseline and at 3, 6 and 12 months follow-ups, and the waitlist-controls at baseline and at 3 months. The primary outcome will be prolonged grief symptoms at the 3 months follow-up. Secondary outcomes are post-traumatic stress and depression symptoms, quality of life and cognitive behavioural variables (ie, avoidance, rumination, negative cognitions).
ETHICS AND DISSEMINATION
Ethical approval has been received from the Swedish Ethical Review Authority (project no. 2021-00770). If the app is shown to be effective, the app will be made publicly accessible on app stores, so that it can benefit other bereaved parents.
TRIAL REGISTRATION NUMBER
NCT04552717.
简介
失去孩子的丧亲父母患心理健康问题的风险增加,但很少有研究评估针对丧亲父母开发的心理社会干预措施的效果。认知行为疗法(CBT),无论是面对面还是通过数字方式提供,都已被证明是治疗长期悲伤症状的有效干预措施。自助移动应用程序具有各种优势,研究表明应用程序干预后心理健康得到改善。目前尚无针对丧亲父母长期悲伤的应用程序进行评估。因此,本计划研究的目的是开发和检验基于认知行为疗法的移动应用程序的有效性,该应用程序称为 ,以减少丧亲父母的长期悲伤症状以及其他心理症状。另一个目的是评估用户的体验和 的不良事件。
方法和分析
我们将进行一项两臂随机等待对照试验。招募在瑞典居住的父母参加试验,他们在一至十年前失去了孩子,并有较高的长期悲伤症状。 涵盖四个主要领域(学习;自我监测;练习;获得支持),并基于认知行为疗法和经过验证的有效 应用程序的原则。干预组的参与者将在基线和 3、6 和 12 个月随访时在线填写问卷,等待对照组在基线和 3 个月时填写。主要结局指标是 3 个月随访时的长期悲伤症状。次要结局指标是创伤后应激和抑郁症状、生活质量和认知行为变量(即回避、反刍、消极认知)。
伦理和传播
瑞典伦理审查局已批准该研究(项目编号 2021-00770)。如果该应用程序被证明有效,它将在应用商店中公开提供,以便其他丧亲父母受益。
试验注册编号
NCT04552717。