A Self-Administered Multicomponent Web-Based Mental Health Intervention for the Mexican Population During the COVID-19 Pandemic: Protocol for a Randomized Controlled Trial

Alejandro Dominguez-Rodriguez, Anabel De La Rosa-Gómez, M Jesús Hernández Jiménez, Paulina Arenas-Landgrave, Sofía Cristina Martínez-Luna, Joabian Alvarez Silva, José Ernesto García Hernández, Carlos Arzola-Sánchez, Victoria Acosta Guzmán, Alejandro Dominguez-Rodriguez, Anabel De La Rosa-Gómez, M Jesús Hernández Jiménez, Paulina Arenas-Landgrave, Sofía Cristina Martínez-Luna, Joabian Alvarez Silva, José Ernesto García Hernández, Carlos Arzola-Sánchez, Victoria Acosta Guzmán

Abstract

Background: 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.

Objective: 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.

Methods: 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).

Results: 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.

Conclusions: 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.

Trial registration: ClinicalTrials.gov NCT04468893; https://ichgcp.net/clinical-trials-registry/NCT04468893.

International registered report identifier (irrid): DERR1-10.2196/23117.

Keywords: cognitive behavioral therapy, behavioral activation therapy, COVID-19; e-health; internet; intervention; positive psychology; telepsychology, Mexican sample.

Conflict of interest statement

Conflicts of Interest: None declared.

©Alejandro Dominguez-Rodriguez, Anabel De La Rosa-Gómez, M Jesús Hernández Jiménez, Paulina Arenas-Landgrave, Sofía Cristina Martínez-Luna, Joabian Alvarez Silva, José Ernesto García Hernández, Carlos Arzola-Sánchez, Victoria Acosta Guzmán. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 16.11.2020.

Figures

Figure 1
Figure 1
Flowchart of the study design for the Mental Health COVID-19 platform. PP: positive psychology.
Figure 2
Figure 2
Screenshot of a module of the Mental Health COVID-19 platform (in Spanish).
Figure 3
Figure 3
Menu showing the modules completed by the participant.
Figure 4
Figure 4
Screenshot showing the integrated chat in the Mental Health COVID-19 platform (in Spanish).

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Source: PubMed

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