A telepsychiatry approach for COVID-19+ patients and family members during and after hospitalization: the DigiCOVID trial protocol (Preprint)

BACKGROUND The COVID-19 pandemic is negatively impacting the mental health of both COVID-19 patients and the general population. Given the current guidelines limiting in person contact to reduce the spread of the virus, a digital approach is needed to tackle the psychological aftermath of the pandemic. Here, we present DigiCOVID, a digital mental health approach to offer remote, personalized support to former or current COVID-19 patients and/or their relatives. OBJECTIVE The main goal of this project is to evaluate the feasibility, acceptability and usability of DigiCOVID. Furthermore, as we have designed DigiCOVID in order to improve mental wellbeing, we also aim to assess the impact of the abovementioned intervention by means of pre-post changes in psychological clinical variables. METHODS Participants undergo an initial phone-based screening to ensure inclusion criteria are met. Then, they complete a neuropsychological test over video to assess IQ, and fill out online self-reports of health and wellbeing. Participants are then assigned to psychotherapist who offers 8 tele-therapy sessions. At the end of the therapy cycle, the online questionnaires are filled out again. RESULTS As of April 2022, we enrolled a total of 122 subjects, of which 94 have completed neuropsychological tests and online questionnaires. CONCLUSIONS Our study aims at testing the feasibility and preliminary efficacy of DigiCOVID, a remote tele-psychiatry approach to tackle the COVID-19 pandemic psychological aftermaths. To date, the approach used seems to be feasible and highly customizable to patients’ needs, and thus DigiCOVID could provide a blueprint for future tele-psychiatry-based interventions. CLINICALTRIAL This study was approved by our local Ethics Committee (IRCCS Ca’ Granda Ospedale Maggiore Policlinico) on 28.10.2020. The trial is registered on clinicaltrials.gov with the following ID: NCT05231018.