Psychosis;SchizophrenicNCT04694482
The Impact of the COVID-19 (SARS-CoV-2 Disease) on Psychopathology
An observational study of Psychosis;Schizophrenic and Personality Disorders, run by University of Milano Bicocca at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychosis;Schizophrenic, Personality Disorders, Mood Disorders
- What is being tested?
- Psychometric scale administration
- How many people
- 270 participants
- Where
- 1 siteItaly
- Study dates
- 12 Nov 2020to 31 Jan 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Psychiatric outpatients and healthy controls resident in the same geographic area as the patients
Who may be able to join
- understanding of the Italian language
- ability to understand and sign written informed consent
Who cannot join
- severe mental retardation
- pregnancy or post-partum period
- severe or chronic medical condition
- health workers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Psychopathological Impact of the SARS-CoV-2 Epidemic on Subjects Suffering From Mental Disorders: Data From ASST Monza
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.
Read the 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.
- Conditions
- Psychosis;Schizophrenic, Personality Disorders, Mood Disorders, Anxiety Disorders, Post Traumatic Stress Disorder
- Being tested
- Psychometric scale administration
- Medical subject headings
- Personality Disorders, Mood Disorders, Anxiety Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychometric scale administrationOther
PTSD symptoms are assessed using a specific scale (IES-R) and compared between the two groups
| Study group | Role | What they receive |
|---|---|---|
| psychiatric patients | Psychometric scales Receives: Other: Psychometric scale administration | |
| healthy controls | Psychometric scales Receives: Other: Psychometric scale administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.).
Measured: 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.).
Measured: 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).
Measured: 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.
Measured: 2 months of lockdown period (T1) and 2 months of reopening phase (T2)
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 2 months at the start of outbreak (T0), 2 months of lockdown period (T1) and 2 months of reopening phase (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start12 Nov 2020
- Primary completion31 Jan 2021
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Psychosis;SchizophrenicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milano Bicocca
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliera San Gerardo di Monza
- Responsible party
- Principal investigator, Fabrizia Colmegna, University of Milano Bicocca
- Investigators
- Fabrizia Colmegna, MD, Principal investigator, ASST Monza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04694482
- Sponsor's protocol ID
- COVID-19-psychiatry
- Status last verified
- Oct 2022
- First submitted
- 30 Dec 2020
- Last updated
- 7 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38728603Caldiroli 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.
PubMed 36093977Caldiroli 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.
PubMed 34902818
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Psychopathological Impact of the SARS-CoV-2 Epidemic on Subjects Suffering From Mental Disorders: Data From ASST Monza
- ClinicalTrials.gov ID
- NCT04694482
- Acronym / sponsor ID
- COVID-19-psychiatry
- Conditions
- Psychosis;Schizophrenic, Personality Disorders, Mood Disorders, Anxiety Disorders, Post Traumatic Stress Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- University of Milano BicoccaUniversity, hospital or other
- Collaborators
- Azienda Ospedaliera San Gerardo di Monza
- Study start
- 12 Nov 2020 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 5 Jan 2021 (actual)
- Results
- Posted 7 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| psychiatric patients | – | Other: Psychometric scale administrationPsychometric scales |
| healthy controls | – | Other: Psychometric scale administrationPsychometric scales |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Psychiatric outpatients and healthy controls resident in the same geographic area as the patients
Key inclusion criteria (2 listed)
- understanding of the Italian language
- ability to understand and sign written informed consent
Key exclusion criteria (4 listed)
- severe mental retardation
- pregnancy or post-partum period
- severe or chronic medical condition
- health workers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychometric scale administrationPTSD symptoms are assessed using a specific scale (IES-R) and compared between the two groups | Other | healthy controls, psychiatric patients |
Primary outcome
Brief Psychiatric Rating Scale (BPRS)
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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.
6 secondary outcomes
Disability Scale (DISS)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 2 months at the start of outbreak (T0), 2 months of lockdown period (T1) and 2 months of reopening phase (T2)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38728603Tagliabue 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.
- Derived from this study: PubMed 36093977Caldiroli 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.
- Derived from this study: PubMed 34902818Caldiroli 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabrizia Colmegna, MD principal investigator
ASST Monza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychosis;Schizophrenic and Personality Disorders, run by University of Milano Bicocca at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Psychiatric Rating Scale (BPRS) (time frame: 2 months at the start of outbreak (T0), 2 months of lockdown period (T1) and 2 months of reopening phase (T2)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04694482, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.