NCT04424771

Brief Summary

The purpose of the questionnaire is to find risk factors for the development of post-traumatic stress disease (PTSD) in health workers during COVID-19 pandemy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

July 27, 2020

Status Verified

July 1, 2020

Enrollment Period

4 months

First QC Date

June 7, 2020

Last Update Submit

July 23, 2020

Conditions

Keywords

COVID-19

Outcome Measures

Primary Outcomes (1)

  • Number of patients with diagnosis of PTSD.

    PTSD consists in job burnout, including emotional exhaustion, depersonalization, and personal accomplishment.

    Through study completion, an average of 1 months

Study Arms (1)

Health workers

They include doctors, nurses, techinicians, biologists and other non technical inhospital workers

Behavioral: Maslach Burnout Inventory (MBI)

Interventions

The Maslach Burnout Inventory is an introspective psychological inventory consisting of 22 items pertaining to occupational burnout.

Health workers

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The population consisted of workers in health services.

You may qualify if:

  • workers in health services, including phisicians, nurses, inhospital technicians and biologists

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ospedale Perrino Asl Brindisi

Brindisi, Italy

Location

Piazza della Vittoria 14 Studio medico - Ginecologia e Ostetricia

Genoa, 16121, Italy

Location

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticCOVID-19

Interventions

Maslach Burnout Inventory

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 7, 2020

First Posted

June 11, 2020

Study Start

March 1, 2020

Primary Completion

June 30, 2020

Study Completion

July 1, 2020

Last Updated

July 27, 2020

Record last verified: 2020-07

Locations