COVID-19 Pandemic Burden in Severe Mental Disease Patients
NCT ID: NCT04357769
Last Updated: 2021-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
400 participants
OBSERVATIONAL
2020-04-10
2020-04-25
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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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
PSS (Perceived Stress Scale)
Self-administered scale for the evaluation of the stress perceived by the subject in the last weeks
GAD-7 (7-item Generalized Anxiety Disorder)
Self-administered scale for the evaluation of anxiety symptoms in the last weeks
PHQ-9 (9-item Patient Health Questionnaire)
Self-administered scale for the evaluation of depressive symptoms in the last weeks
SPEQ (Specific Psychotic Experiences Questionnaire) - Paranoia and Grandiosity Subscales
Self-administered scale for the evaluation of sub-threshold psychotic symptoms in the last weeks
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)
PSS (Perceived Stress Scale)
Self-administered scale for the evaluation of the stress perceived by the subject in the last weeks
GAD-7 (7-item Generalized Anxiety Disorder)
Self-administered scale for the evaluation of anxiety symptoms in the last weeks
PHQ-9 (9-item Patient Health Questionnaire)
Self-administered scale for the evaluation of depressive symptoms in the last weeks
SPEQ (Specific Psychotic Experiences Questionnaire) - Paranoia and Grandiosity Subscales
Self-administered scale for the evaluation of sub-threshold psychotic symptoms in the last weeks
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
PSS (Perceived Stress Scale)
Self-administered scale for the evaluation of the stress perceived by the subject in the last weeks
GAD-7 (7-item Generalized Anxiety Disorder)
Self-administered scale for the evaluation of anxiety symptoms in the last weeks
PHQ-9 (9-item Patient Health Questionnaire)
Self-administered scale for the evaluation of depressive symptoms in the last weeks
SPEQ (Specific Psychotic Experiences Questionnaire) - Paranoia and Grandiosity Subscales
Self-administered scale for the evaluation of sub-threshold psychotic symptoms in the last weeks
Zaritt Burden Interview
Self-administered scale for the evaluation of severe mental disorder patients' caregiver burden
Interventions
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PSS (Perceived Stress Scale)
Self-administered scale for the evaluation of the stress perceived by the subject in the last weeks
GAD-7 (7-item Generalized Anxiety Disorder)
Self-administered scale for the evaluation of anxiety symptoms in the last weeks
PHQ-9 (9-item Patient Health Questionnaire)
Self-administered scale for the evaluation of depressive symptoms in the last weeks
SPEQ (Specific Psychotic Experiences Questionnaire) - Paranoia and Grandiosity Subscales
Self-administered scale for the evaluation of sub-threshold psychotic symptoms in the last weeks
Zaritt Burden Interview
Self-administered scale for the evaluation of severe mental disorder patients' caregiver burden
Eligibility Criteria
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Inclusion Criteria
* Linguistic and cognitive ability to complete the rating scales
* Written informed consent
* Psychopathological compensation at last clinical evaluation on January-February 2020
Exclusion Criteria
* 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
* Living in Northern Italy
* Psychiatric Disorder, of any type
* First degree relative or caregiver of a psychiatric patient
18 Years
70 Years
ALL
No
Sponsors
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Federico II University
OTHER
Responsible Party
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Felice Iasevoli
Associate Professor of Psychiatry
Locations
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University of Naples "Federico II"
Napoli, , Italy
Countries
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Other Identifiers
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152/20
Identifier Type: -
Identifier Source: org_study_id
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