The Impact of the COVID-19 (SARS-CoV-2 Disease) on Psychopathology
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| psychiatric patients Psychometric scales |
Other: Psychometric scale administration
PTSD symptoms are assessed using a specific scale (IES-R) and compared between the two groups
|
| healthy controls Psychometric scales |
Other: Psychometric scale administration
PTSD symptoms are assessed using a specific scale (IES-R) and compared between the two groups
|
Outcome Measures
Primary Outcome Measures
- Brief Psychiatric Rating Scale (BPRS) [Two months]
Range 0-126. Higher scores mean worse outcome.
- Clinical Global Impression (CGI) severity subscale [Two months]
Range 0-7. Higher scores mean worse outcome.
- Clinical Global Impression (CGI) improvement subscale [Two months]
Range 0-7. Higher scores mean worse outcome.
- Hamilton Anxiety Scale (HAM-A) [Two months]
Range 0-56. Higher scores mean worse outcome.
- Impact of Event Scale - Revised version (IES-R) [Two months]
Range 0-88. Higher scores mean worse outcome.
Secondary Outcome Measures
- Disability Scale (DISS) [Two months]
Range 0-10. Higher scores mean worse outcome. Support subscale: Range 0-100. Higher scores mean better outcome.
- Hamilton Depression Rating Scale (HAM-D) [Two months]
Range 0-67. Higher scores mean worse outcome.
- Montgomery and Asberg Depression Rating Scale (MADRS) [Two months]
Range 0-60. Higher scores mean worse outcome.
- Young Mania Rating Scale (YMRS) [Two months]
Range 0-56. Higher scores mean worse outcome.
- Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) [Two months]
Range 0-40. Higher scores mean worse outcome.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
understanding of the Italian language
-
ability to understand and sign written informed consent
Exclusion Criteria:
-
severe mental retardation
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pregnancy or post-partum period
-
severe or chronic medical condition
-
health workers
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Milan Bicocca - Ospedale San Gerardo | Monza | MB | Italy | 20900 |
Sponsors and Collaborators
- University of Milano Bicocca
- Azienda Ospedaliera San Gerardo di Monza
Investigators
- Principal Investigator: Fabrizia Colmegna, MD, ASST Monza
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- COVID-19-psychiatry