COVID-19 Pandemic Burden in Severe Mental Disease Patients (PsyCOVID)

Federico II University

Status: Completed

Conditions: COVID; Severe Mental Disorder; Psychological Distress

Treatments: Other: GAD-7 (7-item Generalized Anxiety Disorder); Other: PSS (Perceived Stress Scale); Other: Zaritt Burden Interview; Other: PHQ-9 (9-item Patient Health Questionnaire); Other: SPEQ (Specific Psychotic Experiences Questionnaire) - Paranoia and Grandiosity Subscales

Study type: Observational

Funder types: Other

Identifiers

NCT04357769

152/20

Details and patient eligibility

About

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.

Enrollment: 400 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

400 participants in 3 patient groups

Patients

Description:

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

Treatment:

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: PSS (Perceived Stress Scale)

Controls (General Population)

Description:

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)

Treatment:

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: PSS (Perceived Stress Scale)

First-degree Relatives

Description:

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

Treatment:

Other: GAD-7 (7-item Generalized Anxiety Disorder)

Other: Zaritt Burden Interview

Other: PHQ-9 (9-item Patient Health Questionnaire)

Other: SPEQ (Specific Psychotic Experiences Questionnaire) - Paranoia and Grandiosity Subscales

Other: PSS (Perceived Stress Scale)