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

NCT04694482 | Completed Results

• 1 other identifier: COVID-19-psychiatry
• Study Type: observational
• Target: 270
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychosis;Schizophrenic; Personality Disorders; Mood Disorders; Anxiety Disorders; Post Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (5)

• 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)

• 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)

• 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)

• 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)

• 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 Outcomes (6)

• 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)

• 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)

• 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)

• 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)

Study Arms (2)

psychiatric patients

Psychometric scales

Other: Psychometric scale administration

healthy controls

Psychometric scales

Other: Psychometric scale administration

Interventions

Psychometric scale administration OTHER

PTSD symptoms are assessed using a specific scale (IES-R) and compared between the two groups

healthy controls; psychiatric patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Psychiatric outpatients and healthy controls resident in the same geographic area as the patients

You may qualify if:

• understanding of the Italian language
• ability to understand and sign written informed consent

You may not qualify if:

• severe mental retardation
• pregnancy or post-partum period
• severe or chronic medical condition
• health workers

Sponsors & Collaborators

• University of Milano Bicocca: lead
• Azienda Ospedaliera San Gerardo di Monza: collaborator

Study Sites (1)

University of Milan Bicocca - Ospedale San Gerardo

Monza, MB, 20900, Italy

Location

Related Publications (3)

• Tagliabue I, Caldiroli A, Capuzzi E, Borgonovo R, Scalia A, Ferre A, Sibilla M, Turco M, Affaticati LM, Crespi G, Galimberti G, Dakanalis A, Colmegna F, Buoli M, Clerici M. Which Factors Are Associated With Comorbid Psychiatric Conditions in Patients Affected by Substance Use Disorders? The Impact of COVID-19 Pandemic on Dual-Diagnosis Subjects. J Dual Diagn. 2024 Jul-Sep;20(3):201-209. doi: 10.1080/15504263.2024.2346519. Epub 2024 May 10.

  PMID: 38728603 DERIVED

• Caldiroli A, Tagliabue I, Turco M, Capuzzi E, Fortunato A, Tringali A, Montana C, Maggioni L, Pellicioli C, Sibilla M, Marcatili M, Crespi G, Colmegna F, Buoli M, Clerici M. Comparing the COVID-19-related PTSD symptoms between psychiatric patients and healthy subjects: an observational retrospective study from Northern Italy. Psychol Health Med. 2023 Jun;28(5):1298-1308. doi: 10.1080/13548506.2022.2121971. Epub 2022 Sep 11.

  PMID: 36093977 DERIVED

• Caldiroli A, Capuzzi E, Tringali A, Tagliabue I, Turco M, Fortunato A, Sibilla M, Montana C, Maggioni L, Pellicioli C, Marcatili M, Nava R, Crespi G, Colmegna F, Buoli M, Clerici M. The psychopathological impact of the SARS-CoV-2 epidemic on subjects suffering from different mental disorders: An observational retrospective study. Psychiatry Res. 2022 Jan;307:114334. doi: 10.1016/j.psychres.2021.114334. Epub 2021 Dec 7.

  PMID: 34902818 DERIVED

MeSH Terms

Conditions

Personality Disorders; Mood Disorders; Anxiety Disorders; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Results Point of Contact

• Title: Dr. Alice Caldiroli
• Organization: ASST Monza

a.caldiroli@asst-monza.it

+3495009941

Study Officials

• Fabrizia Colmegna, MD

  ASST Monza

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: December 30, 2020
• First Posted: January 5, 2021
• Study Start: November 12, 2020
• Primary Completion: January 31, 2021
• Study Completion: January 31, 2021
• Last Updated: September 7, 2023
• Results First Posted: September 7, 2023

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)