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

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Abstract

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

Related collections

Most cited references 30

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A brief measure for assessing generalized anxiety disorder: the GAD-7.

Robert L Spitzer, Kurt Kroenke, Janet B W Williams … (2006)

Generalized anxiety disorder (GAD) is one of the most common mental disorders; however, there is no brief clinical measure for assessing GAD. The objective of this study was to develop a brief self-report scale to identify probable cases of GAD and evaluate its reliability and validity. A criterion-standard study was performed in 15 primary care clinics in the United States from November 2004 through June 2005. Of a total of 2740 adult patients completing a study questionnaire, 965 patients had a telephone interview with a mental health professional within 1 week. For criterion and construct validity, GAD self-report scale diagnoses were compared with independent diagnoses made by mental health professionals; functional status measures; disability days; and health care use. A 7-item anxiety scale (GAD-7) had good reliability, as well as criterion, construct, factorial, and procedural validity. A cut point was identified that optimized sensitivity (89%) and specificity (82%). Increasing scores on the scale were strongly associated with multiple domains of functional impairment (all 6 Medical Outcomes Study Short-Form General Health Survey scales and disability days). Although GAD and depression symptoms frequently co-occurred, factor analysis confirmed them as distinct dimensions. Moreover, GAD and depression symptoms had differing but independent effects on functional impairment and disability. There was good agreement between self-report and interviewer-administered versions of the scale. The GAD-7 is a valid and efficient tool for screening for GAD and assessing its severity in clinical practice and research.

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The PHQ-9: validity of a brief depression severity measure.

K Kroenke, R L Spitzer, J. Williams (2001)

While considerable attention has focused on improving the detection of depression, assessment of severity is also important in guiding treatment decisions. Therefore, we examined the validity of a brief, new measure of depression severity. The Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). The PHQ-9 was completed by 6,000 patients in 8 primary care clinics and 7 obstetrics-gynecology clinics. Construct validity was assessed using the 20-item Short-Form General Health Survey, self-reported sick days and clinic visits, and symptom-related difficulty. Criterion validity was assessed against an independent structured mental health professional (MHP) interview in a sample of 580 patients. As PHQ-9 depression severity increased, there was a substantial decrease in functional status on all 6 SF-20 subscales. Also, symptom-related difficulty, sick days, and health care utilization increased. Using the MHP reinterview as the criterion standard, a PHQ-9 score > or =10 had a sensitivity of 88% and a specificity of 88% for major depression. PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively. Results were similar in the primary care and obstetrics-gynecology samples. In addition to making criteria-based diagnoses of depressive disorders, the PHQ-9 is also a reliable and valid measure of depression severity. These characteristics plus its brevity make the PHQ-9 a useful clinical and research tool.

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Critical Care Utilization for the COVID-19 Outbreak in Lombardy, Italy: Early Experience and Forecast During an Emergency Response

Giacomo Grasselli, Antonio Pesenti, Maurizio Cecconi (2020)

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Author and article information

Contributors

Paolo Brambilla:

ORCID: https://orcid.org/0000-0002-4021-8456

Department of Pathophysiology and TransplantationUniversity of MilanVia Francesco Sforza 53Milano, 20122Italy39 0255035982paolo.brambilla1@unimi.it

Journal

Journal ID (nlm-ta): JMIR Res Protoc

Journal ID (iso-abbrev): JMIR Res Protoc

Journal ID (publisher-id): ResProt

Title: JMIR Research Protocols

Publisher: JMIR Publications (Toronto, Canada )

ISSN (Electronic): 1929-0748

Publication date Collection: November 2022

Publication date (Electronic): 16 November 2022

Publication date PMC-release: 16 November 2022

Volume: 11

Issue: 11

Electronic Location Identifier: e39080

Affiliations

[1 ] Department of Pathophysiology and Transplantation University of Milan Milano Italy

[2 ] Department of Research and Development Posit Science Corporation San Francisco, CA United States

[3 ] 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

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

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

[6 ] Respiratory Unit and Cystic Fibrosis Adult Center Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Ca’ Granda Ospedale Maggiore Policlinico Milano Italy

Author notes

Corresponding Author: Paolo Brambilla paolo.brambilla1@ 123456unimi.it

Author information

Filippo Cantù https://orcid.org/0000-0001-6748-2591

Bruno Biagianti https://orcid.org/0000-0002-5955-3019

Ilaria Lisi https://orcid.org/0000-0002-4699-4341

Elisa R Zanier https://orcid.org/0000-0002-3011-8718

Nicola Bottino https://orcid.org/0000-0003-2459-8310

Chiara Fornoni https://orcid.org/0000-0001-6698-4215

Francesca Gallo https://orcid.org/0000-0001-5526-9187

Valeria Ginex https://orcid.org/0000-0002-3961-5817

Valentina Tombola https://orcid.org/0000-0002-3000-5617

Silvana Zito https://orcid.org/0000-0002-6990-6228

Elisa Colombo https://orcid.org/0000-0001-7959-1330

Nino Stocchetti https://orcid.org/0000-0003-3250-6834

Paolo Brambilla https://orcid.org/0000-0002-4021-8456

Article

Publisher ID: v11i11e39080

DOI: 10.2196/39080

PMC ID: 9674079

PubMed ID: 36228130

SO-VID: 290e50fd-3261-457a-bbde-7814e09afdce

Copyright statement: ©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.

License:

This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.

History

Date received : 27 April 2022

Date revision requested : 2 June 2022

Date revision received : 7 June 2022

Date accepted : 16 June 2022

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Self URI: https://www.researchprotocols.org/2022/11/e39080

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

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Abstract

Background

Objective

Methods

Results

Conclusions

Trial Registration

International Registered Report Identifier (IRRID)

Related collections

JMIR: Research Protocols

Most cited references 30

A brief measure for assessing generalized anxiety disorder: the GAD-7.

The PHQ-9: validity of a brief depression severity measure.

Critical Care Utilization for the COVID-19 Outbreak in Lombardy, Italy: Early Experience and Forecast During an Emergency Response

Author and article information

Contributors

Journal

Affiliations

Author notes

Author information

Article

History

Product

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Comments

Comment on this article

Similar content 370

Cited by 2

Most referenced authors 724