N/A
N=270
The Impact of the COVID-19 (SARS-CoV-2 Disease) on Psychopathology
Psychosis;Schizophrenic · Personality Disorders · Mood Disorders · Anxiety Disorders · Post Traumatic Stress Disorder
Bottom Line
View on ClinicalTrials.gov: NCT04694482 ↗Enrolled (actual)
270
Serious AEs
—
Results posted
Sep 2023
Primary outcome: Primary: Brief Psychiatric Rating Scale (BPRS) — 29.30; 32.80; 30.25 score on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Psychometric scale administration (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Milano Bicocca
- Primary completion
- Jan 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Brief Psychiatric Rating Scale (BPRS) |
29.30; 32.80; 30.25 | — |
| PRIMARY Clinical Global Impression (CGI) Severity Subscale |
4.02; 4.23; 4.10 | — |
| PRIMARY Clinical Global Impression (CGI) Improvement Subscale |
4.37; 3.61 | — |
| PRIMARY Hamilton Anxiety Scale (HAM-A) |
6.81; 10.03; 7.92 | — |
| PRIMARY Impact of Event Scale - Revised Version (IES-R) |
20.18; 24.34; 13.47; 20.57 | — |
| SECONDARY Disability Scale (DISS) |
17.95; 17.50; 17.25 | — |
| SECONDARY Hamilton Depression Rating Scale (HAM-D) |
7.42; 12.57; 8.03 | — |
| SECONDARY Montgomery and Asberg Depression Rating Scale (MADRS) |
9.45; 12.91; 9.69 | — |
| SECONDARY Young Mania Rating Scale (YMRS) |
3.14; 4.69; 3.51 | — |
| SECONDARY Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) |
9.20; 10.40; 10.20 | — |
| SECONDARY Positive And Negative Syndrome Scale (PANSS) |
60.72; 62.49; 62.63 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04694482). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.