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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05381883
Recruitment Status : Not yet recruiting
First Posted : May 19, 2022
Last Update Posted : July 20, 2022
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Charles Perrens, Bordeaux

Tracking Information
First Submitted Date  ICMJE May 6, 2022
First Posted Date  ICMJE May 19, 2022
Last Update Posted Date July 20, 2022
Estimated Study Start Date  ICMJE September 15, 2022
Estimated Primary Completion Date November 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 19, 2022)
  • Prevalence of anxiety disorders [ Time Frame: Baseline ]
    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.
  • Prevalence of anxiety disorders [ Time Frame: Baseline ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 16, 2022)
  • Prevalence of anxiety disorders [ Time Frame: Baseline ]
    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.
  • Prevalence of anxiety disorders [ Time Frame: Baseline ]
    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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 19, 2022)
  • Measure the prevalence of post-traumatic stress disorder [ Time Frame: Baseline ]
    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
  • Measure the prevalence of depressive episodes [ Time Frame: Baseline ]
    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
  • Measure the prevalence of depressive episodes [ Time Frame: Baseline ]
    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
  • Study the professional burnout syndrome [ Time Frame: Baseline ]
    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
  • Study the the quality of life at work among staff [ Time Frame: Baseline ]
    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
  • Study the use of psychostimulant substances (drugs, alcohol, drugs, tobacco) among the staff of accommodation facilities for old people and home help [ Time Frame: Baseline ]
    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).
Original Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2022)
  • Measure the prevalence of post-traumatic stress disorder [ Time Frame: Baseline ]
    Participants will answer the Posttraumatic stress disorder Checklist which is a questionnaire allowing the screening of post-traumatic stress disorder
  • Measure the prevalence of depressive episodes [ Time Frame: Baseline ]
    Participants will answer the Beck Depression Inventory- Fast Screen which is the questionnaire for screening for major depressive disorder
  • Measure the prevalence of depressive episodes [ Time Frame: Baseline ]
    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 ).
  • Study the professional burnout syndrome [ Time Frame: Baseline ]
    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
  • Study the the quality of life at work among staff [ Time Frame: Baseline ]
    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
  • Study the use of psychostimulant substances (drugs, alcohol, drugs, tobacco) among the staff of accommodation facilities for old people and home help [ Time Frame: Baseline ]
    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).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mental Health of Professionals of the Silver Economy of New Aquitaine : Online Survey of Accommodation Establishments for Old People and Home Assistance Establishments
Official Title  ICMJE Mental Health of Professionals of the Silver Economy of New Aquitaine : Online Survey of Accommodation Establishments for Old People and Home Assistance Establishments
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. 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • COVID-19 Pandemic
  • Professional Stress
Intervention  ICMJE 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

Study Arms  ICMJE Epidemiology

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.

Intervention: Other: Questionnaire
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 16, 2022)
4500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2022
Estimated Primary Completion Date November 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Charles-Henry MARTIN, MD 05 56 56 31 30 cmartin@ch-perrens.fr
Contact: Helen SAVARIEAU 05 56 56 35 56 hsavarieau@ch-perrens.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05381883
Other Study ID Numbers  ICMJE 2021-A01953-38
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Centre Hospitalier Charles Perrens, Bordeaux
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Centre Hospitalier Charles Perrens, Bordeaux
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Charles-Henry MARTIN, MD Physician
PRS Account Centre Hospitalier Charles Perrens, Bordeaux
Verification Date January 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP