The Impact of the COVID-19 (SARS-CoV-2 Disease) on Psychopathology

NCT ID: NCT04694482

Last Updated: 2023-09-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 270 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-11-12
• Study Completion Date: 2021-01-31

Brief Summary

The outbreak of the SARS-CoV-2 pandemic may be considered a traumatic phenomenon.

In a sample of subjects suffering from different psychiatric disorders, psychopathological status and Post-Traumatic Stress Disorder (PTSD) symptoms over time are assessed using specific psychometric scales. In a sample of healthy controls PTSD symptoms are evaluated by Impact of Event Scale Revised (IES-R) and compared to patients' scores.

We hypothesize that a significant number of psychiatric outpatients have experienced a clinical psychopathological worsening and a greater prevalence of PTSD symptoms compared to the general population. The study of the potential psychopathological changes could represent a useful contribution to deepen the understanding of psychological consequences of the pandemic.

Detailed Description

SARS-CoV-2 epidemic is a worldwide phenomenon which generated fear, anxiety, depression and PTSD symptoms, as a consequence of the high number of deaths and the restricted measures adopted by the Italian Government to stem the spread of the virus.

The aims of the study are: (1) to investigate potential psychopathological changes over time in a sample of patients affected by different psychiatric disorders (schizophrenia, bipolar disorder, major depression, anxiety/Obsessive-Compulsive Disorder (OCD), personality disorders); (2) to compare patients and healthy controls in terms of post-traumatic symptoms.

Outpatients affected by different psychiatric disorders are recruited during their routine visits and demographic/clinical variables are collected from their medical records.

Psychopathological status and PTSD symptoms are retrospectively assessed using specific psychometric scales, such as Brief Psychiatry Rating Scale (BPRS), Clinical Global Impression (CGI), Disability Scale (DISS), Hamilton Anxiety Rating Scale (HAM-A), Hamilton Depression Rating Scale (HAM-D), Montgomery and Asberg Depression Rating Scale (MADRS), Young Mania Rating Scale (YMRS), Yale-Brown Obsessive-Compulsive Scale (Y-BOCS), IES-R.

The assessment is performed over time at three time points: T0 corresponding to the outbreak of the pandemic (January-February 2020), T1 which was the lockdown period (March-April 2020) and T2 corresponding to the reopening and restarting (May-June 2020).

Descriptive analyses of the whole sample will be performed. Then, mixed linear regression models will be run to investigate the change over time in patients' psychometric scores and whether it differs among different diagnostic groups. Moreover, same analyses will be performed to compare patients and healthy subjects in terms of change of IES-R scores over time.

Conditions

Psychosis;Schizophrenic; Personality Disorders; Mood Disorders; Anxiety Disorders; Post Traumatic Stress Disorder

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

psychiatric patients

Psychometric scales

Psychometric scale administration

Intervention Type: OTHER

PTSD symptoms are assessed using a specific scale (IES-R) and compared between the two groups

healthy controls

Psychometric scales

Psychometric scale administration

Intervention Type: OTHER

PTSD symptoms are assessed using a specific scale (IES-R) and compared between the two groups

Interventions

Psychometric scale administration

PTSD symptoms are assessed using a specific scale (IES-R) and compared between the two groups

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• understanding of the Italian language
• ability to understand and sign written informed consent

Exclusion Criteria

• severe mental retardation
• pregnancy or post-partum period
• severe or chronic medical condition
• health workers

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Azienda Ospedaliera San Gerardo di Monza

OTHER

Sponsor Role: collaborator

University of Milano Bicocca

OTHER

Sponsor Role: lead

Responsible Party

Fabrizia Colmegna

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fabrizia Colmegna, MD

Role: PRINCIPAL_INVESTIGATOR

ASST Monza

Locations

University of Milan Bicocca - Ospedale San Gerardo

Monza, MB, Italy

Countries

Italy

References

Tagliabue I, Caldiroli A, Capuzzi E, Borgonovo R, Scalia A, Ferre A, Sibilla M, Turco M, Affaticati LM, Crespi G, Galimberti G, Dakanalis A, Colmegna F, Buoli M, Clerici M. Which Factors Are Associated With Comorbid Psychiatric Conditions in Patients Affected by Substance Use Disorders? The Impact of COVID-19 Pandemic on Dual-Diagnosis Subjects. J Dual Diagn. 2024 Jul-Sep;20(3):201-209. doi: 10.1080/15504263.2024.2346519. Epub 2024 May 10.

Reference Type: DERIVED

PMID: 38728603 (View on PubMed)

Caldiroli A, Tagliabue I, Turco M, Capuzzi E, Fortunato A, Tringali A, Montana C, Maggioni L, Pellicioli C, Sibilla M, Marcatili M, Crespi G, Colmegna F, Buoli M, Clerici M. Comparing the COVID-19-related PTSD symptoms between psychiatric patients and healthy subjects: an observational retrospective study from Northern Italy. Psychol Health Med. 2023 Jun;28(5):1298-1308. doi: 10.1080/13548506.2022.2121971. Epub 2022 Sep 11.

Reference Type: DERIVED

PMID: 36093977 (View on PubMed)

Caldiroli A, Capuzzi E, Tringali A, Tagliabue I, Turco M, Fortunato A, Sibilla M, Montana C, Maggioni L, Pellicioli C, Marcatili M, Nava R, Crespi G, Colmegna F, Buoli M, Clerici M. The psychopathological impact of the SARS-CoV-2 epidemic on subjects suffering from different mental disorders: An observational retrospective study. Psychiatry Res. 2022 Jan;307:114334. doi: 10.1016/j.psychres.2021.114334. Epub 2021 Dec 7.

Reference Type: DERIVED

PMID: 34902818 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

COVID-19-psychiatry

Identifier Type: -

Identifier Source: org_study_id