Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Azienda Ospedaliera San Gerardo di Monza | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| psychiatric patients | Psychometric scales |
| |
| healthy controls | Psychometric scales |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psychometric scale administration | Other | PTSD symptoms are assessed using a specific scale (IES-R) and compared between the two groups |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Psychiatric outpatients and healthy controls resident in the same geographic area as the patients
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Fabrizia Colmegna, MD | ASST Monza | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Milan Bicocca - Ospedale San Gerardo | Monza | MB | 20900 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38728603 | Derived | 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. | |
| 36093977 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Psychiatric Patients | Patients with different psychiatric diagnoses are included. All the psychometric scales are administered. PTSD symptoms are assessed using a specific scale (IES-R) and compared with healthy controls |
| FG001 | Healthy Controls | PTSD symptoms are assessed using a specific scale (IES-R) and compared with psychiatric patients. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Psychiatric Patients | Patients with different psychiatric diagnoses are included. All the psychometric scales are administered. PTSD symptoms are assessed using a specific scale (IES-R) and compared with healthy controls. |
| BG001 | Healthy Controls |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Only psychiatric patients were assessed for this outcome; data not collected for healthy controls. | Posted | Mean | Standard Deviation | score on a scale | 2 months at the start of outbreak (T0), 2 months of lockdown period (T1) and 2 months of reopening phase (T2) |
|
All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed. We did not test any new compound in the study. The causes of mortality are the same as those of the general population
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Psychiatric Patients | Psychometric scales Psychometric scale administration: PTSD symptoms are assessed using a specific scale (IES-R) and compared between the two groups |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alice Caldiroli | ASST Monza | +3495009941 | a.caldiroli@asst-monza.it |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 20, 2021 | Oct 28, 2022 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D010554 | Personality Disorders |
| D019964 | Mood Disorders |
| D001008 | Anxiety Disorders |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
| 2 months of lockdown period (T1) and 2 months of reopening phase (T2) |
| 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) | 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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. |
| 34902818 | 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. |
PTSD symptoms are assessed using a specific scale (IES-R) and compared with psychiatric patients. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Education | Count of Participants | Participants |
|
| Marital status | Count of Participants | Participants |
|
| Occupational status | Count of Participants | Participants |
|
| Family history of psychiatric disorders | Count of Participants | Participants |
|
| Substance abuse | Count of Participants | Participants |
|
| Medical comorbility | Count of Participants | Participants |
|
| 6-months pre-COVID poly-abuse | Count of Participants | Participants |
|
| 6-months post-COVID poly-abuse | Count of Participants | Participants |
|
| Presence of 2 COVID symptoms | Count of Participants | Participants |
|
| Medical poly-comorbility | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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.). | Only psychiatric patients were assessed for this outcome; data not collected for healthy controls. | Posted | Mean | Standard Deviation | score on a scale | 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.). | Only psychiatric patients were assessed for this outcome; data not collected for healthy controls. | Posted | Mean | Standard Deviation | score on a scale | 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). | Only psychiatric patients were assessed for this outcome; data not collected for healthy controls. | Posted | Mean | Standard Deviation | score on a scale | 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. | Both psychiatric patients and healthy controls were assessed for this outcome. | Posted | Mean | Standard Deviation | score on a scale | 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. | Only psychiatric patients were assessed for this outcome; data not collected for healthy controls. | Posted | Mean | Standard Deviation | score on a scale | 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. | Only bipolar and major depressed patients were assessed for this outcome; data not collected for healthy controls. | Posted | Mean | Standard Deviation | score on a scale | 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). | Only bipolar and major depressed patients were assessed for this outcome; data not collected for healthy controls. | Posted | Mean | Standard Deviation | score on a scale | 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. | Only bipolar patients were assessed for this outcome; data not collected for healthy controls. | Posted | Mean | Standard Deviation | score on a 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). | Only Obsessive-Compulsive patients were assessed for this outcome; data not collected for healthy controls. | Posted | Mean | Standard Deviation | score on a scale | 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. | Only Schizophrenia patients were assessed for this outcome; data not collected for healthy controls. | Posted | Mean | Standard Deviation | score on a scale | 2 months at the start of outbreak (T0), 2 months of lockdown period (T1) and 2 months of reopening phase (T2) |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Healthy Controls | Psychometric scales Psychometric scale administration: PTSD symptoms are assessed using a specific scale (IES-R) and compared between the two groups | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
| High school |
|
| Graduate |
|
| Post-graduate |
|
| Separated/divorced |
|
| Widower |
|
| Never-before-employed |
|
| Invalid-at-work |
|
| Retired |
|
| Bipolar Disorder |
|
| Major Depressive Disorder |
|
| Anxiety disorders |
|
| Eating disorder |
|
| Drug abuse |
|
| Personality Disorders |
|
| Cannabis |
|
| Cocaine |
|
| Heroin |
|
| Benzodiazepines |
|
| Gambling |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|