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      Is Open Access

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

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          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://clinicaltrials.gov/ct2/show/NCT04468893

          International Registered Report Identifier (IRRID)

          DERR1-10.2196/23117

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          Most cited references107

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          G*Power 3: A flexible statistical power analysis program for the social, behavioral, and biomedical sciences

          Franz Faul, Edgar Erdfelder, Albert-Georg Lang … (2007)
          G*Power (Erdfelder, Faul, & Buchner, 1996) was designed as a general stand-alone power analysis program for statistical tests commonly used in social and behavioral research. G*Power 3 is a major extension of, and improvement over, the previous versions. It runs on widely used computer platforms (i.e., Windows XP, Windows Vista, and Mac OS X 10.4) and covers many different statistical tests of the t, F, and chi2 test families. In addition, it includes power analyses for z tests and some exact tests. G*Power 3 provides improved effect size calculators and graphic options, supports both distribution-based and design-based input modes, and offers all types of power analyses in which users might be interested. Like its predecessors, G*Power 3 is free.
          Article 0 comments Cited 7946 times – based on 0 reviews     Review now
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            A brief measure for assessing generalized anxiety disorder: the GAD-7.

            Robert L Spitzer, Kurt Kroenke, Janet B W Williams … (2006)
            Generalized anxiety disorder (GAD) is one of the most common mental disorders; however, there is no brief clinical measure for assessing GAD. The objective of this study was to develop a brief self-report scale to identify probable cases of GAD and evaluate its reliability and validity. A criterion-standard study was performed in 15 primary care clinics in the United States from November 2004 through June 2005. Of a total of 2740 adult patients completing a study questionnaire, 965 patients had a telephone interview with a mental health professional within 1 week. For criterion and construct validity, GAD self-report scale diagnoses were compared with independent diagnoses made by mental health professionals; functional status measures; disability days; and health care use. A 7-item anxiety scale (GAD-7) had good reliability, as well as criterion, construct, factorial, and procedural validity. A cut point was identified that optimized sensitivity (89%) and specificity (82%). Increasing scores on the scale were strongly associated with multiple domains of functional impairment (all 6 Medical Outcomes Study Short-Form General Health Survey scales and disability days). Although GAD and depression symptoms frequently co-occurred, factor analysis confirmed them as distinct dimensions. Moreover, GAD and depression symptoms had differing but independent effects on functional impairment and disability. There was good agreement between self-report and interviewer-administered versions of the scale. The GAD-7 is a valid and efficient tool for screening for GAD and assessing its severity in clinical practice and research.
            Article 0 comments Cited 6155 times – based on 0 reviews     Review now
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              The psychological impact of quarantine and how to reduce it: rapid review of the evidence

              Samantha K. Brooks, Rebecca K Webster, Louise E. Smith … (2021)
              Summary The December, 2019 coronavirus disease outbreak has seen many countries ask people who have potentially come into contact with the infection to isolate themselves at home or in a dedicated quarantine facility. Decisions on how to apply quarantine should be based on the best available evidence. We did a Review of the psychological impact of quarantine using three electronic databases. Of 3166 papers found, 24 are included in this Review. Most reviewed studies reported negative psychological effects including post-traumatic stress symptoms, confusion, and anger. Stressors included longer quarantine duration, infection fears, frustration, boredom, inadequate supplies, inadequate information, financial loss, and stigma. Some researchers have suggested long-lasting effects. In situations where quarantine is deemed necessary, officials should quarantine individuals for no longer than required, provide clear rationale for quarantine and information about protocols, and ensure sufficient supplies are provided. Appeals to altruism by reminding the public about the benefits of quarantine to wider society can be favourable.
              Article 0 comments Cited 5150 times – based on 0 reviews     Review now
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                Author and article information

                Contributors
                Alejandro Dominguez-Rodriguez:
                ORCID: https://orcid.org/0000-0003-3547-8824
                Valencian International UniversityCarrer del Pintor Sorolla, 21Valencia, 46002Spain34 961 92 49 50alejandro.dominguez.r@campusviu.es
                Journal
                Journal ID (nlm-ta): JMIR Res Protoc
                Journal ID (iso-abbrev): JMIR Res Protoc
                Journal ID (publisher-id): ResProt
                Title: JMIR Research Protocols
                Publisher: JMIR Publications (Toronto, Canada )
                ISSN (Electronic): 1929-0748
                Publication date Collection: November 2020
                Publication date (Electronic): 16 November 2020
                Publication date PMC-release: 16 November 2020
                Volume: 9
                Issue: 11
                Electronic Location Identifier: e23117
                Affiliations
                [1 ] Valencian International University Valencia Spain
                [2 ] Coordinación de Educación a Distancia Facultad de Estudios Superiores Iztacala Universidad Nacional Autónoma de México Mexico City Mexico
                [3 ] Facultad de Psicología Universidad Nacional Autónoma de México Mexico City Mexico
                [4 ] ITLAB Mexico Juarez Mexico
                [5 ] Plan Estratégico de Juárez A C Juarez Mexico
                [6 ] Institute of Social Sciences Autonomous University of Ciudad Juárez Juarez Mexico
                Author notes
                Corresponding Author: Alejandro Dominguez-Rodriguez alejandro.dominguez.r@ 123456campusviu.es
                Author information
                https://orcid.org/0000-0003-3547-8824
                https://orcid.org/0000-0002-3527-1500
                https://orcid.org/0000-0001-7933-8968
                https://orcid.org/0000-0002-0578-5367
                https://orcid.org/0000-0002-4782-9065
                https://orcid.org/0000-0003-2737-4574
                https://orcid.org/0000-0003-1765-8776
                https://orcid.org/0000-0002-6774-2813
                https://orcid.org/0000-0002-5545-4902
                Article
                Publisher ID: v9i11e23117
                DOI: 10.2196/23117
                PMC ID: 7704282
                PubMed ID: 33196449
                SO-VID: ce5e435f-3a4c-4835-8dde-df895a93755f
                Copyright statement: ©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.
                License:

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.

                History
                Date received : 1 August 2020
                Date revision requested : 2 October 2020
                Date revision received : 24 October 2020
                Date accepted : 27 October 2020
                Product
                Self URI: http://www.researchprotocols.org/2020/11/e23117/
                Categories
                Subject: Protocol
                Subject: Protocol

                Keywords: e-health,positive psychology,cognitive behavioral therapy, behavioral activation therapy, covid-19,internet,intervention,telepsychology, mexican sample
                Data availability:
                Keywords: e-health, positive psychology, cognitive behavioral therapy, behavioral activation therapy, covid-19, internet, intervention, telepsychology, mexican sample

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