The Psychopathological Impact of the SARS-CoV-2 Epidemic on Subjects Suffering From Mental Disorders: Data From ASST Monza
Conditions: Psychosis;Schizophrenic, Personality Disorders, Mood Disorders, Anxiety Disorders, Post Traumatic Stress Disorder
Sponsor: University of Milano Bicocca

The Psychopathological Impact of the SARS-CoV-2 Epidemic on Subjects Suffering From 
Mental Disorders: Data From ASST Monza 
 
The Impact of the COVID-19 (SARS-CoV-2 Disease) on Psychopathology 
 
 
 
NCT04694482 
 
 
 
 
 
 
 
 
Document date: 20/04/2021 
 
 
 
 
 
 
 
 
 
 
 

STUDY PROTOCOL 
 
Study design and participants 
This is an observational retrospective study involving subjects evaluated at three time points: 
T0, corresponding to the outbreak of the pandemic (January-February 2020); T1, that was the 
lockdown period (the so-called “phase I”, in March-April 2020); T2, corresponding to the reopening 
and restarting (the so-called “phase II”, in May-June 2020). 
Outpatients (aged 18-65) were recruited at three mental health services of ASST Monza: 
Cesano Maderno, Monza and Brugherio. Subjects were interviewed during psychiatric visits from 
November 12th 2020 until January 31st 2020 and information were collected retrospectively for the 
purposes of the study. 
Inclusion criteria for both patients and HC consisted of: (1) being 18-65 years old; (2) ability 
to comprehend the Italian language; (3) ability to understand and sign the written informed consent. 
An additional inclusion criterion for patients was having a diagnosis of SKZ, BD, major depressive 
disorder (MDD), anxiety disorders, OCD or PDs according to the Diagnostic and Statistical Manual 
of Mental Disorders – 5th edition (DSM 5 – APA, 2013) criteria. An additional inclusion criterion 
for HC was living in the same geographical area of patients. 
Exclusion criteria (for both patients and HC) were: (1) severe mental retardation; (2) pregnancy 
or post-partum; (3) presence of medical conditions potentially contributing to psychiatric symptoms 
(e.g. multiple sclerosis or re-exacerbation of inflammatory diseases); (4) treatment with compounds 
potentially involved in the onset or worsening of psychiatric symptoms (e.g. corticosteroids); (5) 
being health care workers involved in the sanitary emergency. Moreover, relatives of patients were 
excluded as HC. 
All participants signed informed consent after the nature of the procedures had been fully 
explained. Study procedures were reviewed and approved by the local accredited Medical Ethics 

Review Committee (named “Brianza Ethic Committee”). The research project is conformed to the 
provisions of the latest version of the Declaration of Helsinki. 
 
Assessment 
Data were collected retrospectively from patients’ medical records or, in case they were lacking, 
by interviews to the patients or their relatives and caregivers. HC were asked to compile a 
questionnaire to collect the same data as patients. Information included demographic variables such 
as age, sex, educational level, occupational status and marital status, as well as clinical variables, such 
as family history of psychiatric disorders, lifetime substance misuse, substance poly-abuse 6 months 
before and 6 months after the pandemic, medical (co)-morbidity, medical poly-comorbidity, the 
presence of at least 2 COVID symptoms, and, for patients, diagnosis. The rating scales are routinely 
administered during patients’ visits. 
 
Primary outcomes 
- Brief Psychiatry Rating Scale (BPRS) at T0, T1, T2; 
- Clinical Global Impression (CGI) severity subscale at T0, T1, T2; improvement subscale at 
T1 and T2; 
- Hamilton Anxiety Rating Scale (HAM-A) at T0, T1, T2; 
- Impact of Event Scale – Revised (IES-R) at T1 and T2. 
These rating scales were administered to all patients. HC were asked to retrospectively fill in 
the IES-R items referring to T1 and T2. 
 
Secondary outcomes 
- Disability Scale (DISS) at T0, T1, T2; 
- Positive and Negative Symptoms Scale (PANSS), collected for SKZ patients at T0, T1, T2; 
- Hamilton Depression Rating Scale (HAM-D) and Montgomery and Åsberg Depression Rating 

Scale (MADRS), collected for MDD and BD patients at T0, T1, T2; 
- Young Mania Rating Scale (YMRS), collected for BD patients at T0, T1, T2; 
- Yale-Brown Obsessive-Compulsive Scale (Y-BOCS), collected for OCD patients at T0, T1, 
T2. 
 
STATISTICAL ANALYSIS PLAN 
 
Descriptive analyses of the entire sample were performed. Patients were divided into 5 groups 
according to diagnosis (SKZ, BD, MDD, anxiety disorders or OCD, PDs); multivariate analyses of 
variance (MANOVAs) and chi-square tests were used to compare groups on quantitative and 
qualitative variables respectively. 
Linear regression models, adjusted for repeated measures, were applied to examine whether the 
change over time in psychometric scores differed between diagnostic groups and, for IES-R, between 
patients and HC. In the models, psychometric scores were treated as dependent variables. The model 
included fixed effects of time and diagnosis. The Akaike information criterion (AIC) was used to 
select the appropriate statistical model. The unstructured variance–covariance matrix was used to 
account for repeated measures within each subject. The significance was set at p<0.05. 
Statistical Package for Social Sciences (SPSS) for Windows (version 26.0) was used as 
statistical program.