Health Research Institute of the Balearic Islands (IdISBa), Palma, Balearic Islands, Spain.
Primary Care Research Unit of Mallorca, Balearic Islands Health Services, Palma, Balearic Islands, Spain.
J Adv Nurs. 2021 Jun;77(6):2898-2907. doi: 10.1111/jan.14813. Epub 2021 Mar 6.
To evaluate the impact of a psychoeducational, mobile health intervention based on cognitive behavioural therapy and mindfulness-based approaches on the mental health of healthcare workers at the frontline against COVID-19 in Spain.
We will carry out a two-week, individually randomized, parallel group, controlled trial. Participants will be individually randomized to receive the PsyCovidApp intervention or control App intervention.
The PsyCovidApp intervention will include five modules: emotional skills, lifestyle behaviour, work stress and burnout, social support, and practical tools. Healthcare workers having attended patients with COVID-19 will be randomized to receive the PsyCovidApp intervention (intervention group) or a control App intervention (control group). A total of 440 healthcare workers will be necessary to assure statistical power. Measures will be collected telephonically by a team of psychologists at baseline and immediately after the 2 weeks intervention period. Measures will include stress, depression and anxiety (DASS-21 questionnaire-primary endpoint), insomnia (ISI), burnout (MBI-HSS), post-traumatic stress disorder (DTS), and self-efficacy (GSE). The study was funded in May 2020, and was ethically approved in June 2020. Trial participants, outcome assessors and data analysts will be blinded to group allocation.
Despite the increasing use of mobile health interventions to deliver mental health care, this area of research is still on its infancy. This study will help increase the scientific evidence about the effectiveness of this type of intervention on this specific population and context.
Despite the lack of solid evidence about their effectiveness, mobile-based health interventions are already being widely implemented because of their low cost and high scalability. The findings from this study will help health services and organizations to make informed decisions in relation to the development and implementation of this type of interventions, allowing them pondering not only their attractive implementability features, but also empirical data about its benefits.
NCT04393818 (ClinicalTrials.gov identifier).
May 2020.
评估基于认知行为疗法和正念的心理教育型移动健康干预措施对西班牙抗击 COVID-19 一线医护人员心理健康的影响。
我们将开展一项为期两周的、个体随机、平行分组、对照试验。参与者将被个体随机分配接受 PsyCovidApp 干预或对照 App 干预。
PsyCovidApp 干预措施将包括五个模块：情绪技能、生活方式行为、工作压力和倦怠、社会支持和实用工具。接触过 COVID-19 患者的医护人员将被随机分配接受 PsyCovidApp 干预（干预组）或对照 App 干预（对照组）。需要 440 名医护人员才能确保统计学效力。在基线和 2 周干预期结束时，由一组心理学家通过电话收集措施。措施将包括压力、抑郁和焦虑（DASS-21 问卷-主要终点）、失眠（ISI）、倦怠（MBI-HSS）、创伤后应激障碍（DTS）和自我效能（GSE）。该研究于 2020 年 5 月获得资金，并于 2020 年 6 月获得伦理批准。试验参与者、结局评估者和数据分析师将对分组情况进行盲法。
尽管移动健康干预措施在提供心理健康护理方面的使用越来越多，但该领域的研究仍处于起步阶段。本研究将有助于增加关于此类干预措施对特定人群和特定环境的有效性的科学证据。
尽管移动健康干预措施的有效性缺乏确凿证据，但由于其成本低、可扩展性高，它们已经得到广泛应用。本研究的结果将有助于卫生服务和组织在制定和实施此类干预措施时做出明智的决策，使他们不仅考虑到这种干预措施具有吸引力的实施特点，还考虑到其益处的实证数据。
NCT04393818（ClinicalTrials.gov 标识符）。
2020 年 5 月。
