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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05381883
Other study ID # 2021-A01953-38
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 15, 2024
Est. completion date November 30, 2026

Study information

Verified date June 2024
Source Centre Hospitalier Charles Perrens, Bordeaux
Contact Charles-Henry MARTIN, MD
Phone 05 56 56 31 30
Email cmartin@ch-perrens.fr
Is FDA regulated No
Health authority
Study type Interventional

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


Description:

This is a repeated cross-sectional descriptive study with two independent collection points six months apart, using socio-economic self-questionnaires and psychometric scales, which aims to measure the incidence of psychological disorders. This study included the completion of questionnaires in a non-clinical population. This is a study aimed at describing a profile of psychological condition in adults.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 4500
Est. completion date November 30, 2026
Est. primary completion date November 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Bad understanding of instructions making consent or assessment impossible - Refusal to participate - Be under measure of legal protection: guardianship, trusteeship or safeguard of justice

Study Design


Intervention

Other:
Questionnaire
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

Locations

Country Name City State
France Centre Hospitalier Charles Perrens Bordeaux

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Charles Perrens, Bordeaux

Country where clinical trial is conducted

France, 

References & Publications (5)

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. — View Citation

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: 10.1177/0706743704049006 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Measure the prevalence of post-traumatic stress disorder Participants will answer the Posttraumatic stress disorder Checklist which is a questionnaire allowing the screening of post-traumatic stress disorder.
Min=0 max=80 Higher score mean a worse outcome
Baseline
Secondary Measure the prevalence of depressive episodes Participants will answer the Beck Depression Inventory- Fast Screen which is the questionnaire for screening for major depressive disorder Min = 0 Max =21 Higher score mean a worse outcome Baseline
Secondary Measure the prevalence of depressive episodes Participants will answer the Coping Inventory for Stressful Situations which is the scale assesses the 4 types of coping strategies (emotion-focused, support-focused, problem-focused, avoidance-focused ).
There are three sub-scales :
Task oriented min=0 max=56 Emotional oriented min=0 max =42 Avoidance oreinted min =0 max =51
Baseline
Secondary Study the professional burnout syndrome Participants will answer the Maslach Burnout Inventory which is the questionnaire allowing the screening of a burn-out.
There are three sub-scales :
Burnout score min =0 max =54 Depersonalization score / Loss of empathy min =0 max=30 For these two subscales: Higher scores mean a worse outcome Personal Achievement Score min = 0 max=48 For this subscale: Higher score mean a better outcome
Baseline
Secondary Study the the quality of life at work among staff Participants will answer the Medical Outcomes Study Short-Form which is the questionnaire to assess the quality of life Min=0 max=100 Higher score mean a better outcome Baseline
Secondary Study the use of psychostimulant substances (drugs, alcohol, drugs, tobacco) among the staff of accommodation facilities for old people and home help The consumption of psychoactive substances will be assessed through a multiple-choice menu, allowing to tick the substances consumed by the participant during the last month. The categories of psychoactive substances are: anxiolytics and sedatives (eg benzodiazepines, hypnotics etc), psycho-stimulants (eg cocaine, amphetamines, ecstasy etc), opiates and related drugs (eg codeine, heroin etc), cannabis, alcohol and tobacco. According to the items, the person will indicate for each psychoactive substance checked the level of consumption (absent, new, increasing, constant). Baseline
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