Dominguez-Rodriguez Alejandro, De La Rosa-Gómez Anabel, Hernández Jiménez M Jesús, Arenas-Landgrave Paulina, Martínez-Luna Sofía Cristina, Alvarez Silva Joabian, García Hernández José Ernesto, Arzola-Sánchez Carlos, Acosta Guzmán Victoria
Valencian International University, Valencia, Spain.
Coordinación de Educación a Distancia, Facultad de Estudios Superiores Iztacala, Universidad Nacional Autónoma de México, Mexico City, Mexico.
JMIR Res Protoc. 2020 Nov 16;9(11):e23117. doi: 10.2196/23117.
The COVID-19 pandemic has become a public health emergency of international concern; it has not only threatened people's physical health but has also affected their mental health and psychological well-being. It is necessary to develop and offer strategies to reduce the psychological impact of the outbreak and promote adaptive coping.
This study protocol aims to describe a self-administered web-based intervention (Mental Health COVID-19) based on the principles of positive psychology supported by elements of cognitive behavioral therapy and behavioral activation therapy to reduce the symptoms of anxiety and depression and increase positive emotions and sleep quality during and after the COVID-19 outbreak through a telepsychology system.
A randomized controlled clinical superiority trial with two independent groups will be performed, with intrasubject measures at four evaluation periods: pretest, posttest, 3-month follow-up, and 6-month follow-up. Participants will be randomly assigned to one of two groups: self-administered intervention with assistance via chat or self-administered intervention without assistance via chat. The total required sample size will be 166 participants (83 per group).
The clinical trial is ongoing. This protocol was approved by the Research Ethics Board of the Free School of Psychology-University of Behavioral Sciences (Escuela libre de Psicología-Universidad de Ciencias del Comportamiento). The aim is to publish the preliminary results in December 2020. A conservative approach will be adopted, and the size effect will be estimated using the Cohen d index with a significance level (α) of .05 (95% reliability) and a conventional 80% power statistic.
The central mechanism of action will be to investigate the effectiveness of an intervention based on positive psychology through a web platform that can be delivered through computers and tablets, with content that has been rigorously contextualized to the Mexican culture to provide functional strategies to help the target users cope with the COVID-19 pandemic.
ClinicalTrials.gov NCT04468893; https://clinicaltrials.gov/ct2/show/NCT04468893.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/23117.
新型冠状病毒肺炎疫情已成为国际关注的突发公共卫生事件；它不仅威胁人们的身体健康，还影响了他们的心理健康和幸福感。制定并提供策略以减轻疫情的心理影响并促进适应性应对是很有必要的。
本研究方案旨在描述一种基于积极心理学原则、辅以认知行为疗法和行为激活疗法要素的自助式网络干预措施（心理健康与新型冠状病毒肺炎），通过远程心理学系统减轻新型冠状病毒肺炎疫情期间及之后的焦虑和抑郁症状，增强积极情绪并改善睡眠质量。
将进行一项有两个独立组的随机对照临床优势试验，在四个评估期进行个体内测量：预测试、后测试、3个月随访和6个月随访。参与者将被随机分配到两组中的一组：通过聊天获得协助的自助式干预组或无聊天协助的自助式干预组。所需的总样本量为166名参与者（每组83名）。
临床试验正在进行中。本方案已获得行为科学大学自由心理学院研究伦理委员会的批准。目标是在2020年12月公布初步结果。将采用保守方法，使用Cohen d指数估计效应量，显著性水平（α）为0.05（95%可靠性）和传统的80%检验效能统计量。
核心作用机制将是通过一个可通过电脑和平板电脑提供的网络平台，研究基于积极心理学的干预措施的有效性，其内容已根据墨西哥文化进行了严格的情境化处理，以提供实用策略来帮助目标用户应对新型冠状病毒肺炎疫情。
ClinicalTrials.gov NCT04468893；https://clinicaltrials.gov/ct2/show/NCT04468893。
国际注册报告识别号（IRRID）：DERR1-10.2196/23117。
