COVID-19 Pandemic Burden in Severe Mental Disease Patients

NCT04357769 | Completed DMC

• 1 other identifier: 152/20
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychological Distress; COVID; Severe Mental Disorder

Outcome Measures

Primary Outcomes (1)

• 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

  10 days

Secondary Outcomes (5)

• Generalized Anxiety Disorder (GAD-7) scale outcome

  10 days

• Patient Health Questionnaire (PHQ-9) scale outcome

  10 days

• Specific Psychotic Experiences Questionnaire (SPEQ) - Paranoia subscale outcome

  10 days

• Specific Psychotic Experiences Questionnaire (SPEQ) - Grandiosity subscale outcome

  10 days

• Caregiver Burden

  10 days

Study Arms (3)

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

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)

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

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

Interventions

PSS (Perceived Stress Scale) OTHER

Self-administered scale for the evaluation of the stress perceived by the subject in the last weeks

Controls (General Population); First-degree Relatives; Patients

GAD-7 (7-item Generalized Anxiety Disorder) OTHER

Self-administered scale for the evaluation of anxiety symptoms in the last weeks

Controls (General Population); First-degree Relatives; Patients

PHQ-9 (9-item Patient Health Questionnaire) OTHER

Self-administered scale for the evaluation of depressive symptoms in the last weeks

Controls (General Population); First-degree Relatives; Patients

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

Self-administered scale for the evaluation of sub-threshold psychotic symptoms in the last weeks

Controls (General Population); First-degree Relatives; Patients

Zaritt Burden Interview OTHER

Self-administered scale for the evaluation of severe mental disorder patients' caregiver burden

First-degree Relatives

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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
• Psychiatric Disorder, of any type
• First degree relative or caregiver of a psychiatric patient

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

University of Naples "Federico II"

Napoli, 80131, Italy

Location

MeSH Terms

Conditions

Mental Disorders

Interventions

Perceived Stress Scale; Patient Health Questionnaire

Intervention Hierarchy (Ancestors)

Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Psychological Tests; Behavioral Disciplines and Activities; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Study Record Dates

• First Submitted: April 16, 2020
• First Posted: April 22, 2020
• Study Start: April 10, 2020
• Primary Completion: April 20, 2020
• Study Completion: April 25, 2020
• Last Updated: February 3, 2021

Record last verified: 2021-02

Locations

IT (1)