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Accepted for/Published in: JMIR Research Protocols

Date Submitted: Apr 27, 2022
Date Accepted: Jun 16, 2022
Date Submitted to PubMed: Oct 13, 2022

The final, peer-reviewed published version of this preprint can be found here:

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

Cantù F, Biagianti B, Lisi I, Zanier E, Bottino N, Fornoni C, Gallo F, Ginex V, Tombola V, Zito S, Colombo E, Stocchetti N, Brambilla P

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

JMIR Res Protoc 2022;11(11):e39080

DOI: 10.2196/39080

PMID: 36228130

PMCID: 9674079

Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.

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

  • Filippo Cantù; 
  • Brunoo Biagianti; 
  • Ilaria Lisi; 
  • Elisa 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 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. Clinical Trial: 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.


 Citation

Please cite as:

Cantù F, Biagianti B, Lisi I, Zanier E, Bottino N, Fornoni C, Gallo F, Ginex V, Tombola V, Zito S, Colombo E, Stocchetti N, Brambilla P

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

JMIR Res Protoc 2022;11(11):e39080

DOI: 10.2196/39080

PMID: 36228130

PMCID: 9674079

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