Pôle de Psychiatrie, Santé Mentale et Addictologie, Hôpitaux Universitaires de Strasbourg, 1 place de l'hôpital, 67000, Strasbourg, France.
Laboratoire de Psychologie des Cognitions, Université de Strasbourg, 12 rue goethe, 67000, Strasbourg, France.
Trials. 2020 Oct 21;21(1):870. doi: 10.1186/s13063-020-04772-7.
The acknowledgment of the mental health toll of the COVID-19 epidemic in healthcare workers has increased considerably as the disease evolved into a pandemic status. Indeed, high prevalence rates of depression, sleep disorders, and post-traumatic stress disorder (PTSD) have been reported in Chinese healthcare workers during the epidemic peak. Symptoms of psychological distress are expected to be long-lasting and have a systemic impact on healthcare systems, warranting the need for evidence-based psychological treatments aiming at relieving immediate stress and preventing the onset of psychological disorders in this population. In the current COVID-19 context, internet-based interventions have the potential to circumvent the pitfalls of face-to-face formats and provide the flexibility required to facilitate accessibility to healthcare workers. Online cognitive behavioral therapy (CBT) in particular has proved to be effective in treating and preventing a number of stress-related disorders in populations other than healthcare workers. The aim of our randomized controlled trial study protocol is to evaluate the efficacy of the 'My Health too' CBT program-a program we have developed for healthcare workers facing the pandemic-on immediate perceived stress and on the emergence of psychiatric disorders at 3- and 6-month follow-up compared to an active control group (i.e., bibliotherapy).
Powered for superiority testing, this six-site open trial involves the random assignment of 120 healthcare workers with stress levels > 16 on the Perceived Stress Scale (PSS-10) to either the 7-session online CBT program or bibliotherapy. The primary outcome is the decrease of PSS-10 scores at 8 weeks. Secondary outcomes include depression, insomnia, and PTSD symptoms; self-reported resilience and rumination; and credibility and satisfaction. Assessments are scheduled at pretreatment, mid-treatment (at 4 weeks), end of active treatment (at 8 weeks), and at 3-month and 6-month follow-up.
This is the first study assessing the efficacy and the acceptability of a brief online CBT program specifically developed for healthcare workers. Given the potential short- and long-term consequences of the COVID-19 pandemic on healthcare workers' mental health, but also on healthcare systems, our findings can significantly impact clinical practice and management of the ongoing, and probably long-lasting, health crisis.
ClinicalTrials.gov NCT04362358 , registered on April 24, 2020.
随着 COVID-19 疫情演变为大流行状态，人们对医护人员心理健康所受影响的认识大大提高。事实上，在疫情高峰期，中国医护人员中报告了较高的抑郁、睡眠障碍和创伤后应激障碍（PTSD）患病率。预计心理困扰症状将持续存在，并对医疗保健系统产生系统性影响，因此需要针对该人群提供基于证据的心理治疗，以缓解当前压力并预防心理障碍的发生。在当前的 COVID-19 背景下，基于互联网的干预措施有可能避免面对面模式的缺陷，并提供促进医护人员获得医疗服务所需的灵活性。特别是在线认知行为疗法（CBT）已被证明在治疗和预防除医护人员以外的人群的多种与压力相关的疾病方面是有效的。我们的随机对照试验研究方案的目的是评估“我的健康也”CBT 计划（我们为应对大流行而开发的针对医护人员的计划）在即时感知压力和 3 个月和 6 个月随访时出现精神障碍方面的疗效，与积极对照组（即阅读疗法）相比。
该六地点开放性试验采用优势测试设计，涉及 120 名压力水平 >16 的医护人员，他们的压力水平高于感知压力量表（PSS-10）的 120 名医护人员被随机分配到 7 节在线 CBT 课程或阅读疗法中。主要结果是在 8 周时 PSS-10 评分的降低。次要结果包括抑郁、失眠和 PTSD 症状；自我报告的韧性和沉思；以及可信度和满意度。评估安排在治疗前、治疗中期（4 周时）、主动治疗结束时（8 周时）以及 3 个月和 6 个月随访时进行。
这是第一项评估专门为医护人员开发的简短在线 CBT 计划的疗效和可接受性的研究。鉴于 COVID-19 大流行对医护人员心理健康以及医疗保健系统的潜在短期和长期影响，我们的研究结果可能会对临床实践和管理当前及可能长期持续的健康危机产生重大影响。
ClinicalTrials.gov NCT04362358，于 2020 年 4 月 24 日注册。
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