A Study of Perceived Distress and Psychological Burden in Patients Suffering From Severe Mental Diseases During the COVID-19 Pandemic in Italy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Perceived Stress Scale (PSS) outcome
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Specific Psychotic Experiences Questionnaire (SPEQ) - Grandiosity subscale outcome(10 days)
- Caregiver Burden(10 days)
- 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)
Investigators
Felice Iasevoli
Associate Professor of Psychiatry
Federico II University