Psychological DistressPsyCOVIDNCT04357769
COVID-19 Pandemic Burden in Severe Mental Disease Patients
An observational study of Psychological Distress and COVID, run by Federico II University at 1 site in Italy.
Trial summary
Despite being originated in Wuhan, in the China mainland region of the Hubei, Italy has been the hardest-hit country in the world by the COVID-19 pandemic during the month of March. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Psychological Distress, COVID, Severe Mental Disorder
- What is being tested?
- PSS (Perceived Stress Scale), GAD-7 (7-item Generalized Anxiety Disorder) and PHQ-9 (9-item Patient Health Questionnaire)
- How many people
- 400 participants
- Where
- 1 siteItaly
- Study dates
- 10 Apr 2020to 25 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- Adult, Older adult
Study population: All subjects included in the study should have been under mass quarantine in the last month and should have been exposed to similar distressing factors during the SARS-CoV-2 outbreak in Italy
Who may be able to join
- DSM-5 Diagnosis of Schizophrenia or Psychosis Spectrum; Bipolar Disorder; REcurrent Major Depressive Disorder
- Linguistic and cognitive ability to complete the rating scales
- Written informed consent
- Psychopathological compensation at last clinical evaluation on January-February 2020
Who cannot join
- SARS-CoV-2 positive, suspected positive, or in recent close contact with positive ones
- Not under strict quarantine, due to work reasons or to any other reason allowing to overcome quarantine
- Current or recent hospitalization (i.e. on March-April), for any reason
- Intellectual disability
- Psychiatric disturbances secondary to general medical conditions or substances
- Serious medical conditions with infaust prognosis or severely affecting the quality of life
Show all 11Show fewer
- Living in Northern Italy
- Adjunctive Exclusion Criteria for the General Population and Caregivers:
- Psychiatric Disorder, of any type
- Adjunctive Exclusion Criteria for the General Population:
- First degree relative or caregiver of a psychiatric patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study of Perceived Distress and Psychological Burden in Patients Suffering From Severe Mental Diseases During the COVID-19 Pandemic in Italy
Despite being originated in Wuhan, in the China mainland region of the Hubei, Italy has been the hardest-hit country in the world by the COVID-19 pandemic during the month of March.
Due to the uncontrollable spread of the contagion, the Italian Government has been forced to impose a series of restrictions and social distancing measures, culminating in the extension of lockdown to the entire Italian territory on March 8th.
Read more
During this period, the general population has been overwhelmed by feelings of worry, anxiety, and discomfort. The discomfort is reinforced by the lengthening of the lockdown, to the point that it may be considered as a mass model of chronic or subchronic mild stress.
The predictable effects of this stress on mental health have already been claimed, Post-traumatic symptoms were found in 7% among 285 Wuhan and surrounding cities' residents during the COVID-19 outbreak. A recent survey in the Italian general population reported similar outcomes.
In this context, the psychic conditions of the most fragile ones, i.e. those already affected by a severe mental disorder, represent a major concern. Having a history of psychiatric illness is regarded as one of the most relevant predictors of a negative psychological impact of quarantine. Patients with severe mental disorders may be among the hardest hit subjects, as they may be more vulnerable by the COVID-19 outbreak for a series of clinical and psychological factors. In the Italian context, the vulnerability of these patients may be increased by the lockdown of mental health services as a consequence of mass quarantine and optimization of health resources toward action to contrast COVID-19-related sanitary emergencies.
Despite several reports investigated the psychological effects of COVID-19 pandemic on health-care workers, COVID-19 affected people, or the general population, at the moment, no study has investigated the effects of the distress caused by fear of contagion and mass quarantine on severe mental disorder patients. The present study aimed at providing a first evaluation of anxiety, depressive, stress-related symptoms in these patients.
- Conditions
- Psychological Distress, COVID, Severe Mental Disorder
- Being tested
- PSS (Perceived Stress Scale), GAD-7 (7-item Generalized Anxiety Disorder), PHQ-9 (9-item Patient Health Questionnaire), SPEQ (Specific Psychotic Experiences Questionnaire) - Paranoia and Grandiosity Subscales, Zaritt Burden Interview
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSS (Perceived Stress Scale)Other
Self-administered scale for the evaluation of the stress perceived by the subject in the last weeks
GAD-7 (7-item Generalized Anxiety Disorder)Other
Self-administered scale for the evaluation of anxiety symptoms in the last weeks
PHQ-9 (9-item Patient Health Questionnaire)Other
Self-administered scale for the evaluation of depressive symptoms in the last weeks
SPEQ (Specific Psychotic Experiences Questionnaire) - Paranoia and Grandiosity SubscalesOther
Self-administered scale for the evaluation of sub-threshold psychotic symptoms in the last weeks
Zaritt Burden InterviewOther
Self-administered scale for the evaluation of severe mental disorder patients' caregiver burden
| Study group | Role | What they receive |
|---|---|---|
| Patients | Individuals aged 18-70 years with a diagnosis of severe mental disorder (schizophrenia or psychosis spectrum disorder; bipolar disorder; major depressive disorder) who were in a condition of psychopathological compensation, had their last clinical evaluation at the University of Naples Federico II outpatient unit of Psychiatry during January-February 2020, were not positive or suspected positive for COVID-19, and were under strict quarantine Receives: Other: PSS (Perceived Stress Scale); Other: GAD-7 (7-item Generalized Anxiety Disorder); Other: PHQ-9 (9-item Patient Health Questionnaire); Other: SPEQ (Specific Psychotic Experiences Questionnaire) - Paranoia and Grandiosity Subscales | |
| Controls (General Population) | Individuals aged 18-70 years who had not a psychiatric condition nor were positive or suspected positive for COVID-19 and were under strict quarantine (e.g. not getting out for work) Receives: Other: PSS (Perceived Stress Scale); Other: GAD-7 (7-item Generalized Anxiety Disorder); Other: PHQ-9 (9-item Patient Health Questionnaire); Other: SPEQ (Specific Psychotic Experiences Questionnaire) - Paranoia and Grandiosity Subscales | |
| First-degree Relatives | Individuals aged 18-70 years who were first-degree relatives and caregivers of an individual included in the Patients group, who had not a psychiatric condition nor were positive or suspected positive for COVID-19 and were under strict quarantine Receives: Other: PSS (Perceived Stress Scale); Other: GAD-7 (7-item Generalized Anxiety Disorder); Other: PHQ-9 (9-item Patient Health Questionnaire); Other: SPEQ (Specific Psychotic Experiences Questionnaire) - Paranoia and Grandiosity Subscales; Other: Zaritt Burden Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress Scale (PSS) outcome
Significant differences among groups in the mean Perceived Stress Scale (PSS) score, which measures the stress severity perceived by the subjects in the last month. The scale is constituted by 10 items that are self-rated by the subject on a 0-4 Likert scale. The scale minimum total score is 0, the maximum is 40. Higher total scores indicate a worse outcome
Measured: 10 days
Secondary outcomes (5)
Generalized Anxiety Disorder (GAD-7) scale outcome
Significant differences among groups in the mean Generalized Anxiety Disorder (GAD-7) scale score, which measures anxiety symptoms' severity in the last two weeks. The scale is constituted by 7 items that are self-rated by the subject on a 0-3 Likert scale. The scale minimum total score is 0, the maximum is 21. Higher total scores indicate a worse outcome
Measured: 10 days
Patient Health Questionnaire (PHQ-9) scale outcome
Significant differences among groups in the mean Patient Health Questionnaire (PHQ-9) scale score, which measures depressive symptoms' severity in the last two weeks. The scale is constituted by 9 items that are self-rated by the subject on a 0-3 Likert scale. The scale minimum total score is 0, the maximum is 21. Higher total scores indicate a worse outcome
Measured: 10 days
Specific Psychotic Experiences Questionnaire (SPEQ) - Paranoia subscale outcome
Significant differences among groups in the mean Specific Psychotic Experiences Questionnaire (SPEQ) - Paranoia subscale score. The SPEQ scale is designed for the assessment of current sub-threshold psychotic symptoms in multiple domains. The Paranoia subscale measures persecutory/reference ideas and is constituted by 15 items that are self-rated by the subject on a 0-5 Likert scale. The subscale minimum total score is 0, the maximum is 75. Higher total scores indicate a worse outcome
Measured: 10 days
Specific Psychotic Experiences Questionnaire (SPEQ) - Grandiosity subscale outcome
Significant differences among groups in the mean Specific Psychotic Experiences Questionnaire (SPEQ) - Grandiosity subscale score. The Grandiosity subscale measures grandiosity/megalomaniac ideas and is constituted by 8 items that are self-rated by the subject on a 0-3 Likert scale. The subscale minimum total score is 0, the maximum is 24. Higher total scores indicate a worse outcome
Measured: 10 days
Caregiver Burden
Significant correlations between mean Zarit Burden Interview (ZBI) and mean scores on the Perceived Stress Scale (PSS). The ZBI is designed for the assessment of caregiver burden. The scale is constituted by 22 items that are self-rated by the subject on a 0-4 Likert scale. The scale minimum total score is 0, the maximum is 88. Higher total scores indicate a worse outcome
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start10 Apr 2020
- Primary completion20 Apr 2020
- Study completion25 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological DistressStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Felice Iasevoli, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04357769
- Sponsor's protocol ID
- 152/20
- Acronym
- PsyCOVID
- Status last verified
- Feb 2021
- First submitted
- 16 Apr 2020
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Perceived Distress and Psychological Burden in Patients Suffering From Severe Mental Diseases During the COVID-19 Pandemic in Italy
- ClinicalTrials.gov ID
- NCT04357769
- Acronym / sponsor ID
- PsyCOVID / 152/20
- Conditions
- Psychological Distress, COVID, Severe Mental Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 10 Apr 2020 (actual)
- Primary completion
- 20 Apr 2020 (actual)
- Study completion
- 25 Apr 2020 (actual)
- First posted
- 22 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Despite being originated in Wuhan, in the China mainland region of the Hubei, Italy has been the hardest-hit country in the world by the COVID-19 pandemic during the month of March.
Due to the uncontrollable spread of the contagion, the Italian Government has been forced to impose a series of restrictions and social distancing measures, culminating in the extension of lockdown to the entire Italian territory on March 8th.
During this period, the general population has been overwhelmed by feelings of worry, anxiety, and discomfort. The discomfort is reinforced by the lengthening of the lockdown, to the point that it may be considered as a mass model of chronic or subchronic mild stress.
The predictable effects of this stress on mental health have already been claimed, Post-traumatic symptoms were found in 7% among 285 Wuhan and surrounding cities' residents during the COVID-19 outbreak. A recent survey in the Italian general population reported similar outcomes.
In this context, the psychic conditions of the most fragile ones, i.e. those already affected by a severe mental disorder, represent a major concern. Having a history of psychiatric illness is regarded as one of the most relevant predictors of a negative psychological impact of quarantine. Patients with severe mental disorders may be among the hardest hit subjects, as they may be more vulnerable by the COVID-19 outbreak for a series of clinical and psychological factors. In the Italian context, the vulnerability of these patients may be increased by the lockdown of mental health services as a consequence of mass quarantine and optimization of health resources toward action to contrast COVID-19-related sanitary emergencies.
Despite several reports investigated the psychological effects of COVID-19 pandemic on health-care workers, COVID-19 affected people, or the general population, at the moment, no study has investigated the effects of the distress caused by fear of contagion and mass quarantine on severe mental disorder patients. The present study aimed at providing a first evaluation of anxiety, depressive, stress-related symptoms in these patients.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: PSS (Perceived Stress Scale), Other: GAD-7 (7-item Generalized Anxiety Disorder), Other: PHQ-9 (9-item Patient Health Questionnaire), Other: SPEQ (Specific Psychotic Experiences Questionnaire) - Paranoia and Grandiosity SubscalesIndividuals aged 18-70 years with a diagnosis of severe mental disorder (schizophrenia or psychosis spectrum disorder; bipolar disorder; major depressive disorder) who were in a condition of psychopathological compensation, had their last clinical evaluation at the University of Naples Federico II outpatient unit of Psychiatry during January-February 2020, were not positive or suspected positive for COVID-19, and were under strict quarantine |
| Controls (General Population) | – | Other: PSS (Perceived Stress Scale), Other: GAD-7 (7-item Generalized Anxiety Disorder), Other: PHQ-9 (9-item Patient Health Questionnaire), Other: SPEQ (Specific Psychotic Experiences Questionnaire) - Paranoia and Grandiosity SubscalesIndividuals aged 18-70 years who had not a psychiatric condition nor were positive or suspected positive for COVID-19 and were under strict quarantine (e.g. not getting out for work) |
| First-degree Relatives | – | Other: PSS (Perceived Stress Scale), Other: GAD-7 (7-item Generalized Anxiety Disorder), Other: PHQ-9 (9-item Patient Health Questionnaire), Other: SPEQ (Specific Psychotic Experiences Questionnaire) - Paranoia and Grandiosity Subscales, Other: Zaritt Burden InterviewIndividuals aged 18-70 years who were first-degree relatives and caregivers of an individual included in the Patients group, who had not a psychiatric condition nor were positive or suspected positive for COVID-19 and were under strict quarantine |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All subjects included in the study should have been under mass quarantine in the last month and should have been exposed to similar distressing factors during the SARS-CoV-2 outbreak in Italy
Key inclusion criteria (4 listed)
- DSM-5 Diagnosis of Schizophrenia or Psychosis Spectrum; Bipolar Disorder; REcurrent Major Depressive Disorder
- Linguistic and cognitive ability to complete the rating scales
- Written informed consent
- Psychopathological compensation at last clinical evaluation on January-February 2020
Key exclusion criteria (11 listed)
- SARS-CoV-2 positive, suspected positive, or in recent close contact with positive ones
- Not under strict quarantine, due to work reasons or to any other reason allowing to overcome quarantine
- Current or recent hospitalization (i.e. on March-April), for any reason
- Intellectual disability
- Psychiatric disturbances secondary to general medical conditions or substances
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 |
|---|---|---|
| PSS (Perceived Stress Scale)Self-administered scale for the evaluation of the stress perceived by the subject in the last weeks | Other | Controls (General Population), First-degree Relatives, Patients |
| GAD-7 (7-item Generalized Anxiety Disorder)Self-administered scale for the evaluation of anxiety symptoms in the last weeks | Other | Controls (General Population), First-degree Relatives, Patients |
| PHQ-9 (9-item Patient Health Questionnaire)Self-administered scale for the evaluation of depressive symptoms in the last weeks | Other | Controls (General Population), First-degree Relatives, Patients |
| SPEQ (Specific Psychotic Experiences Questionnaire) - Paranoia and Grandiosity SubscalesSelf-administered scale for the evaluation of sub-threshold psychotic symptoms in the last weeks | Other | Controls (General Population), First-degree Relatives, Patients |
| Zaritt Burden InterviewSelf-administered scale for the evaluation of severe mental disorder patients' caregiver burden | Other | First-degree Relatives |
Primary outcome
Perceived Stress Scale (PSS) outcome
Time frame: 10 days
Significant differences among groups in the mean Perceived Stress Scale (PSS) score, which measures the stress severity perceived by the subjects in the last month. The scale is constituted by 10 items that are self-rated by the subject on a 0-4 Likert scale. The scale minimum total score is 0, the maximum is 40. Higher total scores indicate a worse outcome
5 secondary outcomes
Generalized Anxiety Disorder (GAD-7) scale outcome
Time frame: 10 days
Patient Health Questionnaire (PHQ-9) scale outcome
Time frame: 10 days
Specific Psychotic Experiences Questionnaire (SPEQ) - Paranoia subscale outcome
Time frame: 10 days
Specific Psychotic Experiences Questionnaire (SPEQ) - Grandiosity subscale outcome
Time frame: 10 days
Caregiver Burden
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Psychological Distress
Recruiting
The Trans-Led Care Study
Substance Abuse, Substance Addiction
Not yet recruiting
Hand in Hand: Feasibility of a Compassion-Focused App to Support Parents of Children With Mental Health Problems
Physiological Conditions, Distress, Emotional
Active, not recruiting
HRVB for Stress and Anxiety During Dentistry Students' Clinical Transition
Stress (Psychology), Anxiety
Recruiting
Effects of a Mindful Self-Compassion Intervention on Psychological Adjustment in Breast Cancer Survivors
Breast Cancer
Not yet recruiting
Group Psychological Intervention to Reduce Distress Among Nursing Undergraduates
Psychological Distress
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Psychological Distress and COVID, run by Federico II University 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 4 inclusion and 11 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 3 Feb 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Perceived Stress Scale (PSS) outcome (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Feb 2021.