TY  - JOUR
AU  - Cantù, Filippo
AU  - Biagianti, Bruno
AU  - Lisi, Ilaria
AU  - R Zanier, Elisa
AU  - Bottino, Nicola
AU  - Fornoni, Chiara
AU  - Gallo, Francesca
AU  - Ginex, Valeria
AU  - Tombola, Valentina
AU  - Zito, Silvana
AU  - Colombo, Elisa
AU  - Stocchetti, Nino
AU  - Brambilla, Paolo
PY  - 2022
DA  - 2022/11/16
TI  - Psychotherapeutic and Psychiatric Intervention in Patients With COVID-19 and Their Relatives: Protocol for the DigiCOVID Trial
JO  - JMIR Res Protoc
SP  - e39080
VL  - 11
IS  - 11
KW  - telepsychiatry
KW  - telemedicine
KW  - COVID-19
KW  - mental health
KW  - digital mental health
KW  - digital support
KW  - clinical outcome
KW  - telehealth
KW  - psychiatric health
KW  - health intervention
AB  - 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://clinicaltrials.gov/ct2/show/NCT05231018?term=NCT05231018 &draw=2&rank=1 International Registered Report Identifier (IRRID): DERR1-10.2196/39080 
SN  - 1929-0748
UR  - https://www.researchprotocols.org/2022/11/e39080
UR  - https://doi.org/10.2196/39080
UR  - http://www.ncbi.nlm.nih.gov/pubmed/36228130
DO  - 10.2196/39080
ID  - info:doi/10.2196/39080
ER  -