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Completed

NCT Number: NCT04357769

COVID-19 Pandemic Burden in Severe Mental Disease Patients

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.

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Key information

Conditions

Psychological Distress COVID Mental Disorders Severe Mental Disorder

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Naples "Federico II"

Naples, 80131, Italy

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PSS (Perceived Stress Scale)

Other

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

GAD-7 (7-item Generalized Anxiety Disorder)

Other

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

PHQ-9 (9-item Patient Health Questionnaire)

Other

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

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

Zaritt Burden Interview

Other

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

Primary outcomes

  1. 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

  1. Generalized Anxiety Disorder (GAD-7) scale outcome

    Time frame: 10 days

    Significant differences among groups in the mean Generalized Anxiety Disorder (GAD-7) scale score, which measures anxiety symptoms' severity in the last two weeks. The scale is constituted by 7 items that are self-rated by the subject on a 0-3 Likert scale. The scale minimum total score is 0, the maximum is 21. Higher total scores indicate a worse outcome

  2. Patient Health Questionnaire (PHQ-9) scale outcome

    Time frame: 10 days

    Significant differences among groups in the mean Patient Health Questionnaire (PHQ-9) scale score, which measures depressive symptoms' severity in the last two weeks. The scale is constituted by 9 items that are self-rated by the subject on a 0-3 Likert scale. The scale minimum total score is 0, the maximum is 21. Higher total scores indicate a worse outcome

  3. Specific Psychotic Experiences Questionnaire (SPEQ) - Paranoia subscale outcome

    Time frame: 10 days

    Significant differences among groups in the mean Specific Psychotic Experiences Questionnaire (SPEQ) - Paranoia subscale score. The SPEQ scale is designed for the assessment of current sub-threshold psychotic symptoms in multiple domains. The Paranoia subscale measures persecutory/reference ideas and is constituted by 15 items that are self-rated by the subject on a 0-5 Likert scale. The subscale minimum total score is 0, the maximum is 75. Higher total scores indicate a worse outcome

  4. Specific Psychotic Experiences Questionnaire (SPEQ) - Grandiosity subscale outcome

    Time frame: 10 days

    Significant differences among groups in the mean Specific Psychotic Experiences Questionnaire (SPEQ) - Grandiosity subscale score. The Grandiosity subscale measures grandiosity/megalomaniac ideas and is constituted by 8 items that are self-rated by the subject on a 0-3 Likert scale. The subscale minimum total score is 0, the maximum is 24. Higher total scores indicate a worse outcome

  5. Caregiver Burden

    Time frame: 10 days

    Significant correlations between mean Zarit Burden Interview (ZBI) and mean scores on the Perceived Stress Scale (PSS). The ZBI is designed for the assessment of caregiver burden. The scale is constituted by 22 items that are self-rated by the subject on a 0-4 Likert scale. The scale minimum total score is 0, the maximum is 88. Higher total scores indicate a worse outcome

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

A Study of Perceived Distress and Psychological Burden in Patients Suffering From Severe Mental Diseases During the COVID-19 Pandemic in Italy

Acronym: PsyCOVID

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 22, 2020
Registry last updated
Feb 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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