NCT05446519

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
870

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 6, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

June 18, 2023

Status Verified

June 1, 2023

Enrollment Period

3 months

First QC Date

June 24, 2022

Last Update Submit

June 16, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

SurveyBEHAVIORAL

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Airline pilot, employed in France and unionized at the Syndicat National des Pilote de Ligne (SNPL)

You may qualify if:

  • Airline pilot, employed in France and unionized at the Syndicat National des Pilote de Ligne (SNPL)

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nice

Nice, France

Location

MeSH Terms

Conditions

Anxiety DisordersDepressive Disorder

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Mental DisordersMood Disorders

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2022

First Posted

July 6, 2022

Study Start

September 1, 2022

Primary Completion

November 15, 2022

Study Completion

April 30, 2023

Last Updated

June 18, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations