The Psychopathological Impact of the SARS-CoV-2 Epidemic on Subjects Suffering From Mental Disorders: Data From ASST Monza
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Psychosis;Schizophrenic
- Sponsor
- University of Milano Bicocca
- Enrollment
- 270
- Locations
- 1
- Primary Endpoint
- Clinical Global Impression (CGI) Severity Subscale
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Fabrizia Colmegna
Medical Doctor
University of Milano Bicocca
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
Outcomes
Primary Outcomes
Clinical Global Impression (CGI) Severity Subscale
Time Frame: 2 months at the start of outbreak (T0), 2 months of lockdown period (T1) and 2 months of reopening phase (T2)
Range 0-7. Higher scores mean worse outcome. The severity subscale measures the global severity of symptom presentation based on the clinicians' evaluation (Normal, Borderline mentally ill, Mildly ill, etc.).
Brief Psychiatric Rating Scale (BPRS)
Time Frame: 2 months at the start of outbreak (T0), 2 months of lockdown period (T1) and 2 months of reopening phase (T2)
Range 0-126. Higher scores mean worse outcome. This psychometric scale measures the global psychopathology investigating several psychopathological areas (anxiety, thinking, mood, perception, etc.). It provides a global score of severity (\> 31 means that the patient need hospitalization).
Clinical Global Impression (CGI) Improvement Subscale
Time Frame: 2 months at the start of outbreak (T0), 2 months of lockdown period (T1) and 2 months of reopening phase (T2)
Range 0-7. Higher scores mean worse outcome. The improvement subscale measures the clinical improvement (how much has the patient changed) according to the clinician's judgement. It results as: very much improved, much improved, minimally improved, no changed, minimally worse, etc.).
Hamilton Anxiety Scale (HAM-A)
Time Frame: 2 months at the start of outbreak (T0), 2 months of lockdown period (T1) and 2 months of reopening phase (T2)
Range 0-56. Higher scores mean worse outcome. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety).
Impact of Event Scale - Revised Version (IES-R)
Time Frame: 2 months of lockdown period (T1) and 2 months of reopening phase (T2)
Range 0-88. Higher scores mean worse outcome. The scale is a self-report measure of current subjective distress in response to a specific traumatic event. It comprises 3 subscales representative of the major symptom clusters of post-traumatic stress: intrusion, avoidance, and hyper-arousal.
Secondary Outcomes
- Montgomery and Asberg Depression Rating Scale (MADRS)(2 months at the start of outbreak (T0), 2 months of lockdown period (T1) and 2 months of reopening phase (T2))
- Disability Scale (DISS)(2 months at the start of outbreak (T0), 2 months of lockdown period (T1) and 2 months of reopening phase (T2))
- Hamilton Depression Rating Scale (HAM-D)(2 months at the start of outbreak (T0), 2 months of lockdown period (T1) and 2 months of reopening phase (T2))
- Young Mania Rating Scale (YMRS)(2 months at the start of outbreak (T0), 2 months of lockdown period (T1) and 2 months of reopening phase (T2))
- Positive And Negative Syndrome Scale (PANSS)(2 months at the start of outbreak (T0), 2 months of lockdown period (T1) and 2 months of reopening phase (T2))
- Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)(2 months at the start of outbreak (T0), 2 months of lockdown period (T1) and 2 months of reopening phase (T2))