Psychotherapeutic and Psychiatric Intervention in Patients With COVID-19 and Their Relatives: Protocol for the DigiCOVID Trial

Filippo Cantù, Bruno Biagianti, Ilaria Lisi, Elisa R Zanier, Nicola Bottino, Chiara Fornoni, Francesca Gallo, Valeria Ginex, Valentina Tombola, Silvana Zito, Elisa Colombo, Nino Stocchetti, Paolo Brambilla, Filippo Cantù, Bruno Biagianti, Ilaria Lisi, Elisa R Zanier, Nicola Bottino, Chiara Fornoni, Francesca Gallo, Valeria Ginex, Valentina Tombola, Silvana Zito, Elisa Colombo, Nino Stocchetti, Paolo Brambilla

Abstract

Background: The COVID-19 pandemic is negatively impacting the mental health of both patients with COVID-19 and the general population. As current guidelines are limiting in-person contacts to reduce the spread of the virus, the development of a digital approach to implement in psychiatric and psychological consultations is needed. In this paper, we present the DigiCOVID protocol, a digital approach to offer remote, personalized psychological and psychiatric support to former or current patients with COVID-19 and their relatives.

Objective: The main goal of this project is to evaluate the feasibility, acceptability, and usability of the DigiCOVID protocol. Furthermore, we also aim to assess the impact of the abovementioned protocol by means of pre-post changes in psychological clinical variables.

Methods: Participants undergo an initial telephonic screening to ensure inclusion criteria are met. Secondly, participants complete a video-assisted neuropsychological IQ test as well as web-based self-reports of health and general well-being. Participants are then assigned to a psychotherapist who offers 8 teletherapy sessions. At the end of the therapy cycle, the web-based questionnaires are administered for a posttreatment evaluation.

Results: As of April 2022, we enrolled a total of 122 participants, of which 94 have completed neuropsychological tests and web-based questionnaires.

Conclusions: Our study aims at testing the feasibility and preliminary efficacy of DigiCOVID, a remote telemedicine protocol for the improvement of psychological and psychiatric health in patients with COVID-19 and their relatives. To date, the approach used seems to be feasible and highly customizable to patients' needs, and therefore, the DigiCOVID protocol might pave the way for future telepsychiatry-based interventions.

Trial registration: ClinicalTrials.gov NCT05231018; https://ichgcp.net/clinical-trials-registry/NCT05231018?term=NCT05231018 &draw=2&rank=1.

International registered report identifier (irrid): DERR1-10.2196/39080.

Keywords: COVID-19; clinical outcome; digital mental health; digital support; health intervention; mental health; psychiatric health; telehealth; telemedicine; telepsychiatry.

Conflict of interest statement

Conflicts of Interest: None declared.

©Filippo Cantù, Bruno Biagianti, Ilaria Lisi, Elisa R Zanier, Nicola Bottino, Chiara Fornoni, Francesca Gallo, Valeria Ginex, Valentina Tombola, Silvana Zito, Elisa Colombo, Nino Stocchetti, Paolo Brambilla. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 16.11.2022.

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