Clinical trial NCT04357769: COVID-19 Pandemic Burden in Severe Mental Disease Patients
Official title: A Study of Perceived Distress and Psychological Burden in Patients Suffering From Severe Mental Diseases During the COVID-19 Pandemic in Italy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psychological Distress
COVID
Severe Mental Disorder
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2020-04-22
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
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

Brief 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.

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Perceived Stress Scale (PSS) outcome
timeFrame: 10 days
Secondary outcomes:
measure: Generalized Anxiety Disorder (GAD-7) scale outcome
timeFrame: 10 days
measure: Patient Health Questionnaire (PHQ-9) scale outcome
timeFrame: 10 days
measure: Specific Psychotic Experiences Questionnaire (SPEQ) - Paranoia subscale outcome
timeFrame: 10 days
measure: Specific Psychotic Experiences Questionnaire (SPEQ) - Grandiosity subscale outcome
timeFrame: 10 days
measure: Caregiver Burden
timeFrame: 10 days
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: University of Naples "Federico II"
Study officials:
References: