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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

Psychotherapeutic and psychiatric intervention in COVID-19 patients and their relatives: the DigiCOVID trial protocol

  • Filippo Cantù; 
  • Bruno 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. 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 consultation 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 COVID-19 patients and/or 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, and complete online self-reports of health and general wellbeing. Participants are then assigned to a psychotherapist who offers 8 tele-therapy sessions. At the end of the therapy cycle, the online questionnaires are administered for a post-treatment evaluation.

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-medicine protocol for the improvement of psychological and psychiatric health in COVID-19 patients and their relatives. To date, the approach used seems to be feasible and highly customizable to patients’ needs, and thus the DigiCOVID protocol might pave the way 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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