Anxiety Disorders, Mood Disorders, Personality Disorders, Post Traumatic Stress Disorder, Psychosis;Schizophrenic
Conditions
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.
Detailed 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.
Interventions
OTHERPsychometric scale administration
PTSD symptoms are assessed using a specific scale (IES-R) and compared between the two groups
Sponsors
Azienda Ospedaliera San Gerardo di Monza
University of Milano Bicocca
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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). |
Countries
Italy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 166 |
| Healthy Controls PTSD symptoms are assessed using a specific scale (IES-R) and compared with psychiatric patients. | 57 |
| Total | 223 |
Baseline characteristics
| Characteristic | Total | Psychiatric Patients | Healthy Controls |
|---|---|---|---|
| 6-months post-COVID poly-abuse No | 215 Participants | 158 Participants | 57 Participants |
| 6-months post-COVID poly-abuse Yes | 8 Participants | 8 Participants | 0 Participants |
| 6-months pre-COVID poly-abuse No | 205 Participants | 148 Participants | 57 Participants |
| 6-months pre-COVID poly-abuse Yes | 18 Participants | 18 Participants | 0 Participants |
| Age, Continuous | 47.85 years STANDARD_DEVIATION 14.64 | 49.22 years STANDARD_DEVIATION 14.23 | 43.86 years STANDARD_DEVIATION 15.19 |
| Education Graduate | 37 Participants | 9 Participants | 28 Participants |
| Education High school | 92 Participants | 77 Participants | 15 Participants |
| Education Post-graduate | 12 Participants | 0 Participants | 12 Participants |
| Education Primary school | 11 Participants | 11 Participants | 0 Participants |
| Education Secondary school | 71 Participants | 69 Participants | 2 Participants |
| Family history of psychiatric disorders Anxiety disorders | 13 Participants | 13 Participants | 0 Participants |
| Family history of psychiatric disorders Bipolar Disorder | 6 Participants | 6 Participants | 0 Participants |
| Family history of psychiatric disorders Drug abuse | 7 Participants | 6 Participants | 1 Participants |
| Family history of psychiatric disorders Eating disorder | 2 Participants | 2 Participants | 0 Participants |
| Family history of psychiatric disorders Major Depressive Disorder | 43 Participants | 33 Participants | 10 Participants |
| Family history of psychiatric disorders None | 125 Participants | 81 Participants | 44 Participants |
| Family history of psychiatric disorders Personality Disorders | 6 Participants | 6 Participants | 0 Participants |
| Family history of psychiatric disorders Schizophrenia | 21 Participants | 19 Participants | 2 Participants |
| Marital status Married/cohabitant | 86 Participants | 46 Participants | 40 Participants |
| Marital status Separated/divorced | 25 Participants | 23 Participants | 2 Participants |
| Marital status Single | 105 Participants | 92 Participants | 13 Participants |
| Marital status Widower | 7 Participants | 5 Participants | 2 Participants |
| Medical comorbility No | 125 Participants | 80 Participants | 45 Participants |
| Medical comorbility Yes | 98 Participants | 86 Participants | 12 Participants |
| Medical poly-comorbility No | 162 Participants | 109 Participants | 53 Participants |
| Medical poly-comorbility Yes | 61 Participants | 57 Participants | 4 Participants |
| Occupational status Employed | 90 Participants | 45 Participants | 45 Participants |
| Occupational status Invalid-at-work | 75 Participants | 75 Participants | 0 Participants |
| Occupational status Never-before-employed | 3 Participants | 3 Participants | 0 Participants |
| Occupational status Retired | 23 Participants | 16 Participants | 7 Participants |
| Occupational status Unemployed | 32 Participants | 27 Participants | 5 Participants |
| Presence of 2 COVID symptoms No | 198 Participants | 161 Participants | 37 Participants |
| Presence of 2 COVID symptoms Yes | 25 Participants | 5 Participants | 20 Participants |
| Race and Ethnicity Not Collected | 0 Participants | — | — |
| Region of Enrollment Italy | 223 participants | 166 participants | 57 participants |
| Sex: Female, Male Female | 111 Participants | 79 Participants | 32 Participants |
| Sex: Female, Male Male | 112 Participants | 87 Participants | 25 Participants |
| Substance abuse Alcohol | 15 Participants | 15 Participants | 0 Participants |
| Substance abuse Benzodiazepines | 2 Participants | 1 Participants | 1 Participants |
| Substance abuse Cannabis | 24 Participants | 17 Participants | 7 Participants |
| Substance abuse Cocaine | 8 Participants | 8 Participants | 0 Participants |
| Substance abuse Gambling | 2 Participants | 2 Participants | 0 Participants |
| Substance abuse Heroin | 4 Participants | 4 Participants | 0 Participants |
| Substance abuse None | 168 Participants | 119 Participants | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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).
Time frame: 2 months at the start of outbreak (T0), 2 months of lockdown period (T1) and 2 months of reopening phase (T2)
Population: Only psychiatric patients were assessed for this outcome; data not collected for healthy controls.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Psychiatric Patients | Brief Psychiatric Rating Scale (BPRS) | T0 | 29.30 score on a scale | Standard Deviation 10.41 |
| Psychiatric Patients | Brief Psychiatric Rating Scale (BPRS) | T1 | 32.80 score on a scale | Standard Deviation 11.04 |
| Psychiatric Patients | Brief Psychiatric Rating Scale (BPRS) | T2 | 30.25 score on a scale | Standard Deviation 9.4 |
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.).
Time frame: 2 months at the start of outbreak (T0), 2 months of lockdown period (T1) and 2 months of reopening phase (T2)
Population: Only psychiatric patients were assessed for this outcome; data not collected for healthy controls.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Psychiatric Patients | Clinical Global Impression (CGI) Improvement Subscale | T1 | 4.37 score on a scale | Standard Deviation 0.97 |
| Psychiatric Patients | Clinical Global Impression (CGI) Improvement Subscale | T2 | 3.61 score on a scale | Standard Deviation 0.91 |
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.).
Time frame: 2 months at the start of outbreak (T0), 2 months of lockdown period (T1) and 2 months of reopening phase (T2)
Population: Only psychiatric patients were assessed for this outcome; data not collected for healthy controls.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Psychiatric Patients | Clinical Global Impression (CGI) Severity Subscale | T0 | 4.02 score on a scale | Standard Deviation 1.31 |
| Psychiatric Patients | Clinical Global Impression (CGI) Severity Subscale | T1 | 4.23 score on a scale | Standard Deviation 1.29 |
| Psychiatric Patients | Clinical Global Impression (CGI) Severity Subscale | T2 | 4.10 score on a scale | Standard Deviation 1.31 |
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).
Time frame: 2 months at the start of outbreak (T0), 2 months of lockdown period (T1) and 2 months of reopening phase (T2)
Population: Only psychiatric patients were assessed for this outcome; data not collected for healthy controls.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Psychiatric Patients | Hamilton Anxiety Scale (HAM-A) | T0 | 6.81 score on a scale | Standard Deviation 8.13 |
| Psychiatric Patients | Hamilton Anxiety Scale (HAM-A) | T1 | 10.03 score on a scale | Standard Deviation 9.02 |
| Psychiatric Patients | Hamilton Anxiety Scale (HAM-A) | T2 | 7.92 score on a scale | Standard Deviation 8.71 |
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.
Time frame: 2 months of lockdown period (T1) and 2 months of reopening phase (T2)
Population: Both psychiatric patients and healthy controls were assessed for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Psychiatric Patients | Impact of Event Scale - Revised Version (IES-R) | T2 | 13.47 score on a scale | Standard Deviation 15.15 |
| Psychiatric Patients | Impact of Event Scale - Revised Version (IES-R) | T1 | 20.18 score on a scale | Standard Deviation 18.29 |
| Healthy Controls | Impact of Event Scale - Revised Version (IES-R) | T1 | 24.34 score on a scale | Standard Deviation 12.91 |
| Healthy Controls | Impact of Event Scale - Revised Version (IES-R) | T2 | 20.57 score on a scale | Standard Deviation 13.37 |
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.
Time frame: 2 months at the start of outbreak (T0), 2 months of lockdown period (T1) and 2 months of reopening phase (T2)
Population: Only psychiatric patients were assessed for this outcome; data not collected for healthy controls.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Psychiatric Patients | Disability Scale (DISS) | T0 | 17.95 score on a scale | Standard Deviation 7.9 |
| Psychiatric Patients | Disability Scale (DISS) | T1 | 17.50 score on a scale | Standard Deviation 7.57 |
| Psychiatric Patients | Disability Scale (DISS) | T2 | 17.25 score on a scale | Standard Deviation 8.01 |
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.
Time frame: 2 months at the start of outbreak (T0), 2 months of lockdown period (T1) and 2 months of reopening phase (T2)
Population: Only bipolar and major depressed patients were assessed for this outcome; data not collected for healthy controls.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Psychiatric Patients | Hamilton Depression Rating Scale (HAM-D) | T0 | 7.42 score on a scale | Standard Deviation 6.44 |
| Psychiatric Patients | Hamilton Depression Rating Scale (HAM-D) | T1 | 12.57 score on a scale | Standard Deviation 12.45 |
| Psychiatric Patients | Hamilton Depression Rating Scale (HAM-D) | T2 | 8.03 score on a scale | Standard Deviation 6.9 |
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).
Time frame: 2 months at the start of outbreak (T0), 2 months of lockdown period (T1) and 2 months of reopening phase (T2)
Population: Only bipolar and major depressed patients were assessed for this outcome; data not collected for healthy controls.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Psychiatric Patients | Montgomery and Asberg Depression Rating Scale (MADRS) | T0 | 9.45 score on a scale | Standard Deviation 8.52 |
| Psychiatric Patients | Montgomery and Asberg Depression Rating Scale (MADRS) | T1 | 12.91 score on a scale | Standard Deviation 9.52 |
| Psychiatric Patients | Montgomery and Asberg Depression Rating Scale (MADRS) | T2 | 9.69 score on a scale | Standard Deviation 8.32 |
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.
Time frame: 2 months at the start of outbreak (T0), 2 months of lockdown period (T1) and 2 months of reopening phase (T2)
Population: Only Schizophrenia patients were assessed for this outcome; data not collected for healthy controls.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Psychiatric Patients | Positive And Negative Syndrome Scale (PANSS) | T0 | 60.72 score on a scale | Standard Deviation 27.33 |
| Psychiatric Patients | Positive And Negative Syndrome Scale (PANSS) | T1 | 62.49 score on a scale | Standard Deviation 32.96 |
| Psychiatric Patients | Positive And Negative Syndrome Scale (PANSS) | T2 | 62.63 score on a scale | Standard Deviation 25.85 |
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).
Time frame: 2 months at the start of outbreak (T0), 2 months of lockdown period (T1) and 2 months of reopening phase (T2)
Population: Only Obsessive-Compulsive patients were assessed for this outcome; data not collected for healthy controls.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Psychiatric Patients | Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) | T1 | 10.40 score on a scale | Standard Deviation 10.87 |
| Psychiatric Patients | Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) | T2 | 10.20 score on a scale | Standard Deviation 11.49 |
| Psychiatric Patients | Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) | T0 | 9.20 score on a scale | Standard Deviation 10 |
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.
Time frame: 2 months at the start of outbreak (T0), 2 months of lockdown period (T1) and 2 months of reopening phase (T2)
Population: Only bipolar patients were assessed for this outcome; data not collected for healthy controls.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Psychiatric Patients | Young Mania Rating Scale (YMRS) | T0 | 3.14 score on a scale | Standard Deviation 5.84 |
| Psychiatric Patients | Young Mania Rating Scale (YMRS) | T1 | 4.69 score on a scale | Standard Deviation 9.04 |
| Psychiatric Patients | Young Mania Rating Scale (YMRS) | T2 | 3.51 score on a scale | Standard Deviation 7.04 |