NCT05381883

Brief Summary

The purpose of this study is identify the psychological impact of the coronavirus-19 pandemic on professionals in residential care facilities for old people and home help professionals in New-Aquitaine by :

  1. 1.Large-scale screening for the prevalence of mental health disorders among staff.
  2. 2.Identification of vulnerability and resilience factors.
  3. 3.Improving access to early care for affected professionals.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
4,500

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Sep 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress74%
Sep 2024Nov 2026

First Submitted

Initial submission to the registry

May 6, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 19, 2022

Completed
2.3 years until next milestone

Study Start

First participant enrolled

September 15, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Expected
Last Updated

June 20, 2024

Status Verified

June 1, 2024

Enrollment Period

3 months

First QC Date

May 6, 2022

Last Update Submit

June 17, 2024

Conditions

Keywords

COVID-19Health ProfessionalsPsychological troublesHealth institution

Outcome Measures

Primary Outcomes (2)

  • Prevalence of anxiety disorders

    The appearance of symptoms of anxiety disorders measured through the General Anxiety Disorder-7 questionnaire A total score greater than 7 should lead to the hypothesis of a generalized anxiety disorder. A total score between 5 and 9 corresponds to mild anxiety, a score of 10 to 14 corresponds to moderate anxiety and a score above 15 corresponds to severe anxiety.

    Baseline

  • Prevalence of anxiety disorders

    The appearance of symptoms of anxiety disorders measured through the Panic Disorder Self-Report questionnaire. This questionnaire is a 24-item self-report measure designed to diagnose panic disorder based on Diagnostic and Statistical Manual-IV and Diagnostic and Statistical Manual-V criteria. Most of items are answered in a simple Yes/No fashion. Nevertheless, there are also some questions, for example about severity, which are answered on 5-point Likert scales. Not all of the questions have to be answered by every patient. If a panic disorder can already be excluded, the questionnaire stops.

    Baseline

Secondary Outcomes (6)

  • Measure the prevalence of post-traumatic stress disorder

    Baseline

  • Measure the prevalence of depressive episodes

    Baseline

  • Measure the prevalence of depressive episodes

    Baseline

  • Study the professional burnout syndrome

    Baseline

  • Study the the quality of life at work among staff

    Baseline

  • +1 more secondary outcomes

Study Arms (1)

Epidemiology

OTHER

Participants will answer sociodemographic questions, questions about the experience of potentially traumatic lifelong events, the presence of a known psychological or medical disorder and the taking of drug treatment. These questionnaires will make it possible to detect the main psychological disorders (post-traumatic stress disorder, depression, panic disorder, generalized anxiety disorder), to evaluate coping strategies, the presence of professional exhaustion (burnout), the consumption of psychoactive substances and quality of life.

Other: Questionnaire

Interventions

Participants will answer socio-demographic questions, questions about the lifetime experience of potentially traumatic events, the presence of a known psychological or medical disorder and the taking of medication, and a series of psychological assessment questionnaires. The questionnaires, performed outside routine care, are as follows : Posttraumatic stress disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders-5 Beck Depression Inventory-Fast Screen General Anxiety Disorder-7 Coping Inventory for Stressful Situations Maslach Burnout Inventory Medical Outcomes Study Short-Form The total time for completing the questionnaires is estimated at 20 minutes

Epidemiology

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be aged 18 and over,
  • Have given their consent to participate in the study,
  • Work in an accommodation establishment for the elderly or professional home help in New Aquitaine.
  • Master the French language.
  • Accept online reviews
  • Be a beneficiary of health insurance

You may not qualify if:

  • Bad understanding of instructions making consent or assessment impossible
  • Refusal to participate
  • Be under measure of legal protection: guardianship, trusteeship or safeguard of justice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Charles Perrens

Bordeaux, 33076, France

Location

Related Publications (5)

  • Mohammed A, Sheikh TL, Poggensee G, Nguku P, Olayinka A, Ohuabunwo C, Eaton J. Mental health in emergency response: lessons from Ebola. Lancet Psychiatry. 2015 Nov;2(11):955-7. doi: 10.1016/S2215-0366(15)00451-4. No abstract available.

  • Chan AO, Huak CY. Psychological impact of the 2003 severe acute respiratory syndrome outbreak on health care workers in a medium size regional general hospital in Singapore. Occup Med (Lond). 2004 May;54(3):190-6. doi: 10.1093/occmed/kqh027.

  • Chua SE, Cheung V, McAlonan GM, Cheung C, Wong JW, Cheung EP, Chan MT, Wong TK, Choy KM, Chu CM, Lee PW, Tsang KW. Stress and psychological impact on SARS patients during the outbreak. Can J Psychiatry. 2004 Jun;49(6):385-90. doi: 10.1177/070674370404900607.

  • Csikszentmihalyi M, Larson R. Validity and reliability of the Experience-Sampling Method. J Nerv Ment Dis. 1987 Sep;175(9):526-36. doi: 10.1097/00005053-198709000-00004.

  • Greenberg N, Docherty M, Gnanapragasam S, Wessely S. Managing mental health challenges faced by healthcare workers during covid-19 pandemic. BMJ. 2020 Mar 26;368:m1211. doi: 10.1136/bmj.m1211. No abstract available.

MeSH Terms

Conditions

COVID-19Occupational Stress

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesOccupational DiseasesStress, PsychologicalBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Charles-Henry MARTIN, MD

    Physician

    STUDY DIRECTOR

Central Study Contacts

Charles-Henry MARTIN, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2022

First Posted

May 19, 2022

Study Start

September 15, 2024

Primary Completion

November 30, 2024

Study Completion (Estimated)

November 30, 2026

Last Updated

June 20, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations