UNASSIGNED: We present the study protocol for a multicentre (two sites), parallel-group (1:1 allocation ratio), analyst-blinded, superiority, randomised controlled trial. Healthcare workers with psychological distress will be allocated either to care as usual only or to care as usual plus a stepped-care programme that includes two scalable psychological interventions developed by the World Health Organization: A guided self-help stress management guide (Doing What Matters in Times of Stress) and a five-session cognitive behavioural intervention (Problem Management Plus). All participants will receive a single-session emotional support intervention, namely psychological first aid. We will include 212 participants. An intention-to-treat analysis using linear mixed models will be conducted to explore the programme\'s effect on anxiety and depression symptoms, as measured by the Patient Health Questionnaire - Anxiety and Depression Scale summary score at 21 weeks from baseline. Secondary outcomes include post-traumatic stress disorder symptoms, resilience, quality of life, cost impact and cost-effectiveness.
UNASSIGNED: This study is the first randomised trial that combines two World Health Organization psychological interventions tailored for health workers into one stepped-care programme. Results will inform occupational and mental health prevention, treatment, and recovery strategies.
UNASSIGNED: ClinicalTrials.gov Identifier: NCT04980326.
未经评估:我们提出了多中心(两个站点)的研究方案,平行组(1:1分配比例),分析师失明,优越性,随机对照试验。有心理困扰的医护人员将被分配到照常照护,或照常照护,再加上由世界卫生组织开发的两个可扩展的心理干预措施:一个有指导的自助压力管理指南(做什么在压力的时候很重要)和一个五节认知行为干预(问题管理加)。所有参与者都将接受一次单独的情感支持干预,即心理急救。我们将包括212名参与者。将进行使用线性混合模型的意向治疗分析,以探索该计划对焦虑和抑郁症状的影响,根据基线21周时患者健康问卷-焦虑和抑郁量表汇总评分进行测量。次要结果包括创伤后应激障碍症状,弹性,生活质量,成本影响和成本效益。
UNASSIGNED:这项研究是第一个随机试验,将世界卫生组织为卫生工作者量身定制的两项心理干预措施结合到一个分级护理计划中。结果将告知职业和心理健康预防,治疗,和恢复战略。
UNASSIGNED:ClinicalTrials.gov标识符:NCT04980326。