Mediavilla Roberto, McGreevy Kerry R, Felez-Nobrega Mireia, Monistrol-Mula Anna, Bravo-Ortiz María-Fe, Bayón Carmen, Rodríguez-Vega Beatriz, Nicaise Pablo, Delaire Audrey, Sijbrandij Marit, Witteveen Anke B, Purgato Marianna, Barbui Corrado, Tedeschi Federico, Melchior Maria, van der Waerden Judith, McDaid David, Park A-La, Kalisch Raffael, Petri-Romão Papoula, Underhill James, Bryant Richard A, Haro Josep Maria, Ayuso-Mateos José Luis
Department of Psychiatry, Universidad Autónoma de Madrid (UAM), Madrid, Spain.
Centro de Investigación Biomédica en Red de Salud Mental (CIBERSAM), Instituto de Salud Carlos III, Madrid, Spain.
Digit Health. 2022 Oct 5;8:20552076221129084. doi: 10.1177/20552076221129084. eCollection 2022 Jan-Dec.
The coronavirus disease 2019 pandemic has challenged health services worldwide, with a worsening of healthcare workers' mental health within initial pandemic hotspots. In early 2022, the Omicron variant is spreading rapidly around the world. This study explores the effectiveness and cost-effectiveness of a stepped-care programme of scalable, internet-based psychological interventions for distressed health workers on self-reported anxiety and depression symptoms.
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.
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.
ClinicalTrials.gov Identifier: NCT04980326.
2019年冠状病毒病大流行给全球卫生服务带来了挑战，在最初的疫情热点地区，医护人员的心理健康状况不断恶化。2022年初，奥密克戎变异株在全球迅速传播。本研究探讨了一种针对心理健康受困扰的医护人员的逐步照护计划的有效性和成本效益，该计划采用可扩展的基于互联网的心理干预措施来改善自我报告的焦虑和抑郁症状。
我们介绍了一项多中心（两个地点）、平行组（1:1分配比例）、分析人员设盲、优效性随机对照试验的研究方案。有心理困扰的医护人员将被随机分配，要么仅接受常规护理，要么接受常规护理加逐步照护计划，该计划包括世界卫生组织开发的两种可扩展心理干预措施：一份自助式压力管理指南（《压力下做重要的事》）和一个为期五节的认知行为干预（问题管理加强版）。所有参与者都将接受一次情感支持干预，即心理急救。我们将纳入212名参与者。将使用线性混合模型进行意向性分析，以探讨该计划对焦虑和抑郁症状的影响，这通过从基线起21周时的患者健康问卷 - 焦虑和抑郁量表总分来衡量。次要结局包括创伤后应激障碍症状、心理韧性、生活质量、成本影响和成本效益。
本研究是第一项将世界卫生组织为医护人员量身定制的两种心理干预措施整合到一个逐步照护计划中的随机试验。研究结果将为职业和心理健康预防、治疗及康复策略提供依据。
ClinicalTrials.gov标识符：NCT04980326。
