The Impact of the COVID-19 (SARS-CoV-2 Disease) on Psychopathology

Anxiety Disorders Clinical Trial

Official title:

The Psychopathological Impact of the SARS-CoV-2 Epidemic on Subjects Suffering From Mental Disorders: Data From ASST Monza

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04694482
• Other study ID #: COVID-19-psychiatry
• Status: Completed
• Start date: November 12, 2020
• Est. completion date: January 31, 2021

Study information

• Verified date: October 2022
• Source: University of Milano Bicocca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: January 31, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Mood Disorders
• Personality Disorders
• Post Traumatic Stress Disorder
• Psychosis;Schizophrenic
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Other:
• Psychometric scale administration
PTSD symptoms are assessed using a specific scale (IES-R) and compared between the two groups

Locations

Country	Name	City	State
Italy	University of Milan Bicocca - Ospedale San Gerardo	Monza	MB

Sponsors (2)

Lead Sponsor	Collaborator
University of Milano Bicocca	Azienda Ospedaliera San Gerardo di Monza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brief Psychiatric Rating Scale (BPRS)	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).	2 months at the start of outbreak (T0), 2 months of lockdown period (T1) and 2 months of reopening phase (T2)
Primary	Clinical Global Impression (CGI) Severity Subscale	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.).	2 months at the start of outbreak (T0), 2 months of lockdown period (T1) and 2 months of reopening phase (T2)
Primary	Clinical Global Impression (CGI) Improvement Subscale	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.).	2 months at the start of outbreak (T0), 2 months of lockdown period (T1) and 2 months of reopening phase (T2)
Primary	Hamilton Anxiety Scale (HAM-A)	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).	2 months at the start of outbreak (T0), 2 months of lockdown period (T1) and 2 months of reopening phase (T2)
Primary	Impact of Event Scale - Revised Version (IES-R)	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.	2 months of lockdown period (T1) and 2 months of reopening phase (T2)
Secondary	Disability Scale (DISS)	Range 0-30. Higher scores mean worse outcome. The scale includes 3 self-rated items designed to measure the extent to which 3 major domains (work 0-10, social life/leisure activities 0-10, and family life/home responsibilities 0-10) in the patient's life are functionally impaired by psychiatric or medical symptoms. For each subscale, higher scores mean better outcome. Subscales are summed to compute a total score.	2 months at the start of outbreak (T0), 2 months of lockdown period (T1) and 2 months of reopening phase (T2)
Secondary	Hamilton Depression Rating Scale (HAM-D)	Range 0-67. Higher scores mean worse outcome. The scale measures the severity of depressive symptoms taking into account anxiety and somatic manifestations.	2 months at the start of outbreak (T0), 2 months of lockdown period (T1) and 2 months of reopening phase (T2)
Secondary	Montgomery and Asberg Depression Rating Scale (MADRS)	Range 0-60. Higher scores mean worse outcome. The scale measures the core symptoms of depression (e.g. anhedonia).	2 months at the start of outbreak (T0), 2 months of lockdown period (T1) and 2 months of reopening phase (T2)
Secondary	Young Mania Rating Scale (YMRS)	Range 0-56. Higher scores mean worse outcome. The scale has 11 items and is based on the patient's subjective report of his or her clinical condition, and generally limited to the previous 48 hours. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale.	2 months at the start of outbreak (T0), 2 months of lockdown period (T1) and 2 months of reopening phase (T2)
Secondary	Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)	Range 0-40. Higher scores mean worse outcome. The scale is a semi-structured interview that consists of 10 core items, 5 measuring time, interference, distress, resistance and control of obsessions (items: 1-5), and 5 identical items measuring compulsions (items: 6-10). The items are rated from 0 (no symptoms) to 4 (severe symptoms), and yield a global severity score (range 0-40).	2 months at the start of outbreak (T0), 2 months of lockdown period (T1) and 2 months of reopening phase (T2)
Secondary	Positive And Negative Syndrome Scale (PANSS)	Range 30-210. Higher scores mean worse outcome. The scale is a medical scale used for measuring symptom severity of patients with schizophrenia. It assesses positive symptoms, which refer to an excess or distortion of normal functions (e.g., hallucinations and delusions), and negative symptoms, which represent a diminution or loss of normal functions. The patient is rated from 1 to 7 on 30 different symptoms based on the interview as well as reports of family members or primary care hospital workers.	2 months at the start of outbreak (T0), 2 months of lockdown period (T1) and 2 months of reopening phase (T2)