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

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.

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

Primary outcomes

• Brief Psychiatric Rating Scale (BPRS) [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) Severity Subscale [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.).
• Clinical Global Impression (CGI) Improvement Subscale [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) [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) [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

• Disability Scale (DISS) [2 months at the start of outbreak (T0), 2 months of lockdown period (T1) and 2 months of reopening phase (T2)]: 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.
• 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)]: Range 0-67. Higher scores mean worse outcome. The scale measures the severity of depressive symptoms taking into account anxiety and somatic manifestations.
• 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)]: Range 0-60. Higher scores mean worse outcome. The scale measures the core symptoms of depression (e.g. anhedonia).
• 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)]: 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.
• 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)]: 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).
• 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)]: 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.

Sex: All, ages: 18 Years to 65 Years, accepts healthy volunteers

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

Participant flow

Outcome results

• Brief Psychiatric Rating Scale (BPRS) (Primary), Mean, score on a scale: Psychiatric Patients 29.30 +/- 10.41
• Clinical Global Impression (CGI) Severity Subscale (Primary), Mean, score on a scale: Psychiatric Patients 4.02 +/- 1.31
• Clinical Global Impression (CGI) Improvement Subscale (Primary), Mean, score on a scale: Psychiatric Patients 4.37 +/- 0.97
• Hamilton Anxiety Scale (HAM-A) (Primary), Mean, score on a scale: Psychiatric Patients 6.81 +/- 8.13
• Impact of Event Scale - Revised Version (IES-R) (Primary), Mean, score on a scale: Psychiatric Patients 20.18 +/- 18.29; Healthy Controls 24.34 +/- 12.91
• Disability Scale (DISS) (Secondary), Mean, score on a scale: Psychiatric Patients 17.95 +/- 7.90
• Hamilton Depression Rating Scale (HAM-D) (Secondary), Mean, score on a scale: Psychiatric Patients 7.42 +/- 6.44
• Montgomery and Asberg Depression Rating Scale (MADRS) (Secondary), Mean, score on a scale: Psychiatric Patients 9.45 +/- 8.52
• Young Mania Rating Scale (YMRS) (Secondary), Mean, score on a scale: Psychiatric Patients 3.14 +/- 5.84
• Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) (Secondary), Mean, score on a scale: Psychiatric Patients 9.20 +/- 10.00
• Positive And Negative Syndrome Scale (PANSS) (Secondary), Mean, score on a scale: Psychiatric Patients 60.72 +/- 27.33

Adverse events

Time frame: All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.

• Results publication: 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
• Results publication: 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
• Results publication: 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

• Study Protocol and Statistical Analysis Plan (PDF, 2021-04-20)

• Fabrizia Colmegna, MD, Principal investigator, ASST Monza