Anxiety and / or Depressive Disorders in a Population of... | NCT05446519

Studies
Anxiety and / or Depressive Disorders in a Population of French Airline Pilot

NCT05446519

Sponsor

Centre Hospitalier Universitaire de Nice

Status

Completed

Last Update Posted

Jun 18, 2023Actual

Enrollment

870Actual

Phase

Not provided

Conditions

Anxiety Disorders
Depressive Disorder

Interventions

Survey

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2022Actual

Primary Completion Date

Nov 15, 2022Actual

Completion Date

Apr 30, 2023Actual

First Submitted Date

Jun 24, 2022

First Submission Date that Met QC Criteria

Jul 5, 2022

First Posted Date

Jul 6, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 16, 2023

Last Update Posted Date

Jun 18, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

870Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Survey	Behavioral	Survey is proposed to all pilots who are members of the National Union of Airline Pilots

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

None

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001008	Anxiety Disorders
D003866	Depressive Disorder

Ancestor Terms

ID	Term
D001523	Mental Disorders
D019964	Mood Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided