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Completed

NCT Number: NCT04978220

Mental and Psychological Problems and Insomnia Disorder of Medical Staff in Hospital With Infected COVID-19 Patients

The objective of this study is to clarify the severity of psychological problems and insomnia and the two's relationship with time of hospital medical staff in hospital where its staff are infected with COVID-19.

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Key information

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University Sixth Hospital

Beijing, Beijing Municipality, 100191, China

About this study

A cross-sectional questionnaire survey method was adopted to conduct investigations of medical staff in the researched hospital within one week (baseline) and one year (follow-up) after the discovery of COVID-19 infection cases. 360 subjects were included in the baseline. Then, after one year, 199 subjects who participated in the survey at baseline were included as follow-up. The HADS, ASDS and ISI scales were used to assess the anxiety and depression level, acute stress disorder symptoms, and the severity of insomnia of hospital medical staff; self-made questionnaires was to collect demographic information and descriptive content. Comparing the follow-up medical staff with the baseline, the total scores of ASDS, HADS and ISI, each item scores on the ASDS, HADS and ISI. All of above scales are compared between the quarantined and non-quarantined groups, different quarantined groups (home, hotel, hospital) and non-quarantined groups.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • all medical staff of a third-level general hospital in Beijing who discovered a sporadic case of COVID-19 infection; Volunteer to participate in surveys and follow-ups

Exclusion criteria

  • Incomplete information fills in, which affects the result analysis

Treatment and study plan

Primary outcomes

  1. Hospital Anxiety and Depression Scale (HADS)

    Time frame: 1 year

    HADS is used to assess the anxiety and depression symptoms of medical staff in general hospitals. There are 14 items in total, divided into two parts-the anxiety subscale (HADS-A) and the depression subscale (HADS-D). A total score of 0-7 is classified as asymptomatic, 8-10 is classified as marginal/suspicious, and 11-21 is classified as abnormal.

Secondary outcomes

  1. Acute Stress Disorder Scale (ASDS)

    Time frame: 1 year

    ASDS is a self-rating scale, compiled according to the diagnostic criteria of the fourth edition of the "Manual of Diagnosis and Statistics of Mental Disorders", used to assess acute stress disorder (ASD) symptoms and predict post-traumatic stress disorder (PTSD).

Other outcomes

  1. Insomnia Severity Index (Insomnia Severity Index, ISI)

    Time frame: 1 year

    ISI is a simple tool for screening insomnia, including 7 items to assess the severity of the subjects' sleep symptoms, the subjects' satisfaction with their sleep patterns, the impact of the degree of insomnia on daily functions, the subjects' awareness of the impact of insomnia on themselves, and the level of depression caused by sleep disorders.

Sponsors and collaborators

Lead sponsor

Peking University Sixth Hospital

Other

Registry information

Official study title

Follow-up Study on Mental and Psychological Problems and Insomnia Disorder of Medical Staff in Hospital Where Staff Are Infected With COVID-19

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Jul 27, 2021
Registry last updated
Jul 27, 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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