Anxiety DisordersAEROPSYNCT05446519
Anxiety and / or Depressive Disorders in a Population of French Airline Pilot
An observational study of Anxiety Disorders and Depressive Disorder, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety Disorders, Depressive Disorder
- What is being tested?
- Survey
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 870 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2022to 30 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Airline pilot, employed in France and unionized at the Syndicat National des Pilote de Ligne (SNPL)
Who may be able to join
- Airline pilot, employed in France and unionized at the Syndicat National des Pilote de Ligne (SNPL)
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Descriptive Study of Anxiety and/or Depressive Disorders in a Population of Airline Pilots Employed in France and Unionized at the SNPL
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.
- Conditions
- Anxiety Disorders, Depressive Disorder
- Being tested
- Survey
- Medical subject headings
- Anxiety Disorders, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyBehavioural
Survey is proposed to all pilots who are members of the National Union of Airline Pilots
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start1 Sep 2022
- Primary completion15 Nov 2022
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 870 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05446519
- Sponsor's protocol ID
- 22-PP-09
- Acronym
- AEROPSY
- Status last verified
- Jun 2023
- First submitted
- 24 Jun 2022
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Descriptive Study of Anxiety and/or Depressive Disorders in a Population of Airline Pilots Employed in France and Unionized at the SNPL
- ClinicalTrials.gov ID
- NCT05446519
- Acronym / sponsor ID
- AEROPSY / 22-PP-09
- Conditions
- Anxiety Disorders, Depressive Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 870 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 15 Nov 2022 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 6 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Airline pilot, employed in France and unionized at the Syndicat National des Pilote de Ligne (SNPL)
Key inclusion criteria (1 listed)
- Airline pilot, employed in France and unionized at the Syndicat National des Pilote de Ligne (SNPL)
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveySurvey is proposed to all pilots who are members of the National Union of Airline Pilots | Behavioural | – |
Primary outcome
Depressive and anxiety disorders
Time frame: at baseline
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety Disorders and Depressive Disorder, run by Centre Hospitalier Universitaire de Nice 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 18 Jun 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive and anxiety disorders (time frame: at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2023.