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

COVID-19 clinical outcome digital mental health digital support health intervention mental health psychiatric health telehealth telemedicine telepsychiatry

Journal

JMIR research protocols
ISSN: 1929-0748
Titre abrégé: JMIR Res Protoc
Pays: Canada
ID NLM: 101599504

Informations de publication

Date de publication:
16 Nov 2022
Historique:
received: 27 04 2022
accepted: 16 06 2022
revised: 07 06 2022
pubmed: 14 10 2022
medline: 14 10 2022
entrez: 13 10 2022
Statut: epublish

Résumé

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. 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. 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. As of April 2022, we enrolled a total of 122 participants, of which 94 have completed neuropsychological tests and web-based questionnaires. 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. ClinicalTrials.gov NCT05231018; https://clinicaltrials.gov/ct2/show/NCT05231018?term=NCT05231018 &draw=2&rank=1. DERR1-10.2196/39080.

Sections du résumé

BACKGROUND 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 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 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 RESULTS
As of April 2022, we enrolled a total of 122 participants, of which 94 have completed neuropsychological tests and web-based questionnaires.
CONCLUSIONS 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 BACKGROUND
ClinicalTrials.gov NCT05231018; https://clinicaltrials.gov/ct2/show/NCT05231018?term=NCT05231018 &draw=2&rank=1.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) UNASSIGNED
DERR1-10.2196/39080.

Identifiants

pubmed: 36228130
pii: v11i11e39080
doi: 10.2196/39080
pmc: PMC9674079
doi:

Banques de données

ClinicalTrials.gov
['NCT05231018']

Types de publication

Journal Article

Langues

eng

Pagination

e39080

Informations de copyright

©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.

Références

JAMA Intern Med. 2020 Jun 1;180(6):817-818
pubmed: 32275292
J Affect Disord. 2020 Oct 1;275:78-79
pubmed: 32658828
Cad Saude Publica. 2020 Apr 30;36(4):e00054020
pubmed: 32374806
BMJ. 2020 Jun 29;369:m2541
pubmed: 32601049
JAMA. 2020 Apr 28;323(16):1545-1546
pubmed: 32167538
J Anxiety Disord. 2020 Mar;70:102196
pubmed: 32078967
JMIR Pediatr Parent. 2020 Jun 25;3(1):e20049
pubmed: 32540841
J Gen Intern Med. 2001 Sep;16(9):606-13
pubmed: 11556941
Psychiatry Res. 2020 Sep;291:113213
pubmed: 32535508
Int J Eat Disord. 2020 Jul;53(7):1155-1157
pubmed: 32449523
Arch Intern Med. 2006 May 22;166(10):1092-7
pubmed: 16717171
Clin Pediatr (Phila). 2020 Sep;59(9-10):853-855
pubmed: 32462929
Am J Psychiatry. 2011 Dec;168(12):1266-77
pubmed: 22193671
JMIR Ment Health. 2020 Aug 28;7(8):e21108
pubmed: 32658857
Psychiatry Res. 2021 Apr;298:113802
pubmed: 33592401
Front Psychiatry. 2022 Mar 10;13:834753
pubmed: 35356719
JMIR Ment Health. 2020 Jul 22;7(7):e21718
pubmed: 32668402
BMC Med Res Methodol. 2021 Aug 10;21(1):163
pubmed: 34376151
Sleep. 2011 May 01;34(5):601-8
pubmed: 21532953
JAMA Psychiatry. 2020 Sep 1;77(9):974-976
pubmed: 32352480
JMIR Pediatr Parent. 2020 Jul 28;3(2):e19867
pubmed: 32634105
Front Neurol. 2022 Mar 24;13:774953
pubmed: 35401416
Depress Anxiety. 2020 Oct;37(10):957-964
pubmed: 32667117
Lancet Child Adolesc Health. 2020 Aug;4(8):634-640
pubmed: 32540024

Auteurs

Filippo Cantù (F)

Department of Pathophysiology and Transplantation, University of Milan, Milano, Italy.

Bruno Biagianti (B)

Department of Pathophysiology and Transplantation, University of Milan, Milano, Italy.
Department of Research and Development, Posit Science Corporation, San Francisco, CA, United States.

Ilaria Lisi (I)

Laboratory of Acute Brain Injury and Therapeutic Strategies, Department of Neuroscience, Istituto di Ricerche Farmacologiche Mario Negri Istituto di Ricovero e Cura a Carattere Scientifico, Milano, Italy.

Elisa R Zanier (E)

Laboratory of Acute Brain Injury and Therapeutic Strategies, Department of Neuroscience, Istituto di Ricerche Farmacologiche Mario Negri Istituto di Ricovero e Cura a Carattere Scientifico, Milano, Italy.

Nicola Bottino (N)

Department of Anaesthesia and Critical Care, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy.

Chiara Fornoni (C)

Department of Neurosciences and Mental Health, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy.

Francesca Gallo (F)

Respiratory Unit and Cystic Fibrosis Adult Center, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy.

Valeria Ginex (V)

Department of Neurosciences and Mental Health, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy.

Valentina Tombola (V)

Department of Neurosciences and Mental Health, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy.

Silvana Zito (S)

Department of Neurosciences and Mental Health, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy.

Elisa Colombo (E)

Department of Neurosciences and Mental Health, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy.

Nino Stocchetti (N)

Department of Pathophysiology and Transplantation, University of Milan, Milano, Italy.
Department of Anaesthesia and Critical Care, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy.

Paolo Brambilla (P)

Department of Pathophysiology and Transplantation, University of Milan, Milano, Italy.
Department of Neurosciences and Mental Health, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy.

Classifications MeSH