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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05446519
Other study ID # 22-PP-09
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2022
Est. completion date April 30, 2023

Study information

Verified date June 2023
Source Centre Hospitalier Universitaire de Nice
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Throughout their career, the medical abilities of airline pilots are regularly assessed. This population is exposed to occupational constraints and risks, in particular psychosocial, and could constitute a population at risk of developing anxiety and/or depressive disorders. However, mental health remains difficult to apprehend in this population because of a strong stigmatization of mental disorders and the risk of loss of medical certification to fly. In the literature, there are very few studies dealing with mental disorders in airline pilots and the results are heterogeneous, with a prevalence of anxiety and/or depressive disorders ranging from 1.9 to 12.6%. There is no study of this type among airline pilots employed in France. Therefore it seems useful to determine the prevalence of anxiety and/or depressive disorders in this population and to describe the co-factors associated with these disorders.


Recruitment information / eligibility

Status Completed
Enrollment 870
Est. completion date April 30, 2023
Est. primary completion date November 15, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Airline pilot, employed in France and unionized at the Syndicat National des Pilote de Ligne (SNPL) Exclusion Criteria: - None

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Survey
Survey is proposed to all pilots who are members of the National Union of Airline Pilots

Locations

Country Name City State
France CHU de Nice Nice

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Depressive and anxiety disorders Anxiety and depressive disorders as measured by Hospital Anxiety and Depression Scale (HAD-S). The HADS consists of 14 items, seven items indicating anxiety and seven items indicating depression. The answer format offers four options, scored with values from 0 to 3. This results in scale values between 0 and 21 for each scale. Three ranges were defined by the original test authors: 0-7 (non-cases), 8-10 (doubtful cases), and 11-21 (cases) at baseline
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