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AzTrials

COVID-19 PandemicSILVER NANCT05381883

Mental Health of Professionals of the Silver Economy of New Aquitaine : Online Survey of Accommodation Establishments for Old People and Home Assistance Establishments

A study testing Questionnaire in people with COVID-19 Pandemic and Professional Stress, run by Centre Hospitalier Charles Perrens, Bordeaux at 1 site in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Ages 18 to 99 yearsHealthy volunteers can take part
Conditions the study is for
COVID-19 Pandemic, Professional Stress
What is being tested?
Questionnaire
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,500 participants
Where
1 siteFrance
Study dates
15 Sep 2024to 30 Nov 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Charles-Henry MARTIN, MD contact

05 56 56 31 30

cmartin@ch-perrens.fr

Helen SAVARIEAU contact

05 56 56 35 56

hsavarieau@ch-perrens.fr

France1 site

  • Centre Hospitalier Charles Perrens

    Bordeaux, 33076

    Charles-Martin MARTIN, MD, 05 56 56 31 30, cmartin@ch-perrens.fr

Other trials in France

About this study

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.
Read the detailed 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.

Being tested
Questionnaire
Keywords
COVID-19, Health Professionals, Psychological troubles, Health institution
Medical subject headings
COVID-19, Occupational Stress

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QuestionnaireOther

    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

Study groups in NCT05381883
Study groupRoleWhat they receive
EpidemiologyOtherParticipants 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.
Receives: Other: Questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline

  2. 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.

    Measured: Baseline

Secondary outcomes (6)

  1. 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

    Measured: Baseline

  2. 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

    Measured: Baseline

  3. 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

    Measured: Baseline

  4. 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

    Measured: Baseline

  5. 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

    Measured: Baseline

  6. 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).

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2022
  2. Study start15 Sep 2024 (estimated)
  3. Primary completion30 Nov 2024 (estimated)
  4. Study completion30 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
4,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05381883
Sponsor's protocol ID
2021-A01953-38
Acronym
SILVER NA
Status last verified
Jun 2024
First submitted
6 May 2022
Last updated
20 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 26544738

  • 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.

    PubMed 15133143

  • 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.

    PubMed 15283533

  • 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.

    PubMed 3655778

  • 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.

    PubMed 32217624

Questions about this trial

What is this clinical trial studying?

A study testing Questionnaire in people with COVID-19 Pandemic and Professional Stress, run by Centre Hospitalier Charles Perrens, Bordeaux at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Charles-Henry MARTIN, MD (05 56 56 31 30, cmartin@ch-perrens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of anxiety disorders (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05381883, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2024.

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