Clinical trial NCT04694482: The Impact of the COVID-19 (SARS-CoV-2 Disease) on Psychopathology
Official title: The Psychopathological Impact of the SARS-CoV-2 Epidemic on Subjects Suffering From Mental Disorders: Data From ASST Monza
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psychosis;Schizophrenic
Personality Disorders
Mood Disorders
Anxiety Disorders
Post Traumatic Stress Disorder
Lead sponsor: University of Milano Bicocca
Sponsor class: OTHER
Collaborators: name: Azienda Ospedaliera San Gerardo di Monza
First posted: 2021-01-05
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Psychiatric outpatients and healthy controls resident in the same geographic area as the patients

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.

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

Primary outcomes:
measure: Brief Psychiatric Rating Scale (BPRS)
timeFrame: 2 months at the start of outbreak (T0), 2 months of lockdown period (T1) and 2 months of reopening phase (T2)
measure: Clinical Global Impression (CGI) Severity Subscale
timeFrame: 2 months at the start of outbreak (T0), 2 months of lockdown period (T1) and 2 months of reopening phase (T2)
measure: Clinical Global Impression (CGI) Improvement Subscale
timeFrame: 2 months at the start of outbreak (T0), 2 months of lockdown period (T1) and 2 months of reopening phase (T2)
measure: Hamilton Anxiety Scale (HAM-A)
timeFrame: 2 months at the start of outbreak (T0), 2 months of lockdown period (T1) and 2 months of reopening phase (T2)
measure: Impact of Event Scale - Revised Version (IES-R)
timeFrame: 2 months of lockdown period (T1) and 2 months of reopening phase (T2)
Secondary outcomes:
measure: Disability Scale (DISS)
timeFrame: 2 months at the start of outbreak (T0), 2 months of lockdown period (T1) and 2 months of reopening phase (T2)
measure: Hamilton Depression Rating Scale (HAM-D)
timeFrame: 2 months at the start of outbreak (T0), 2 months of lockdown period (T1) and 2 months of reopening phase (T2)
measure: Montgomery and Asberg Depression Rating Scale (MADRS)
timeFrame: 2 months at the start of outbreak (T0), 2 months of lockdown period (T1) and 2 months of reopening phase (T2)
measure: Young Mania Rating Scale (YMRS)
timeFrame: 2 months at the start of outbreak (T0), 2 months of lockdown period (T1) and 2 months of reopening phase (T2)
measure: Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)
timeFrame: 2 months at the start of outbreak (T0), 2 months of lockdown period (T1) and 2 months of reopening phase (T2)
measure: Positive And Negative Syndrome Scale (PANSS)
timeFrame: 2 months at the start of outbreak (T0), 2 months of lockdown period (T1) and 2 months of reopening phase (T2)
Other outcomes:
Locations:
city: Monza
country: Italy
facility: University of Milan Bicocca - Ospedale San Gerardo
state: MB
Study officials:
affiliation: ASST Monza
name: Fabrizia Colmegna, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.