Chronic Stress DisorderU-CARENCT06907030
Wear and Tear on Military Personnel Post Caledonian Crisis
An observational study of Chronic Stress Disorder, run by Direction Centrale du Service de Santé des Armées at 1 site in France.
Trial summary
Since May 2024, New Caledonia has been experiencing a period of crisis. The organisation of the work of military personnel on the ground has been heavily impacted, with longer working hours, shorter rest periods and increased stress levels (uncertainty about the situation, lack of visibility, etc.). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Stress Disorder
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 3 Apr 2025to Apr 2026
- How long will I take part?
- 2 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Serving military personnel aged between 18 and 65 posted to New Caledonia at the time of the study, i.e. between April and July 2025.
Who may be able to join
- be a member of the military
- be permanently posted to NC at the time of the study
Who cannot join
- Be on temporary assignment in NC at the time of the study
- Subjects covered by articles L1121-5 to 1121-8 of the Public Health Code, i.e. :
- Pregnant women, women in labour and nursing mothers
- Persons deprived of their liberty by judicial or administrative decision
- Persons subject to psychiatric monitoring under articles L3212-1 and L3213-1 who are not covered by the provisions of article L1121-8
- Persons of full age who are the subject of a legal protection measure or who are unable to express their consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
NOUMEA
Noumea
RAMDANI C MD, +33662194297, celineramdani@hotmail.fr
About this study
Official title: Evaluation of Operational Wear and Tear Related to the Caledonian Crisis on Military Personnel
Since May 2024, New Caledonia has been experiencing a period of crisis. The organisation of the work of military personnel on the ground has been heavily impacted, with longer working hours, shorter rest periods and increased stress levels (uncertainty about the situation, lack of visibility, etc.).
Prolonged exposure to stress is accompanied by neuronal damage (Ramdani et al., 2024) and operational fatigue, a mindset that results from reversible neuronal damage and appears to be distinct from exhaustion. The aim of this study is to assess the impact of the crisis on the level of operational fatigue. In addition, identifying the organisational and human factors (Jaspers et al., 2024) that may have been protective against operational fatigue could help to optimise the way in which these factors are taken into account in the event of future crises, in order to promote resilience.
Read the detailed description
Military personnel face specific operational constraints related to their activity. These constraints require physiological adaptation, which can lead to overall biological wear and tear. In our case, the term 'operational wear and tear' refers to the mindset or mental state induced by operational constraints and the chronic stress they impose.
The soldiers deployed in New Caledonia since the riots in May 2024 have had to cope with operational constraints linked to their job, as well as those linked to the insurrection situation. By modifying the physical constraints (longer working hours, less sleep, etc.) and psychological constraints (for example, the unknown duration of the crisis), the current crisis in New Caledonia may have increased operational wear and tear.
The investigators hypothesise that soldiers present in New Caledonia when the riots began have accumulated additional stress related to the crisis and that this could result in greater operational wear and tear than soldiers transferred to New Caledonia in the summer of 2024. However, it is possible that the stress of moving to New Caledonia will counterbalance this effect. For this reason, the study is being conducted over 2 months, in order to assess the evolutionary profile of operational wear and tear.
This is a single-centre observational study of healthy military personnel in New Caledonia. Subjects will be volunteers and their participation or non-participation will not influence their ability to serve, their promotion or their career. Their superiors will not be informed of their participation or non-participation.
Military personnel will be given an oral presentation of the study. On this occasion, the information note will be distributed to them. If they are volunteers, they will have an inclusion visit, notify their non-objection and fill in the first questionnaire. Between two months later, they will complete the second questionnaire.
- Conditions
- Chronic Stress Disorder
- Being tested
- No intervention
- Keywords
- operational wear and tear, resilience, organisational and human factor, psychosocial risk
- Medical subject headings
- Lacerations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| exposed group | Exposed group is the group of military personnel present in New Caledonia at the start of the crisis, i.e. in May 2024, and still posted to New Caledonia at the time of the study, i.e. in April 2025. Receives: Other: No intervention | |
| control group | Control group is the group of military personnel not present in New Caledonia at the start of the crisis, i.e. in May 2024, posted to New Caledonia in the summer of 2024 and present at the time of the study, i.e. in April 2025. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing operational wear and tear linked to the crisis
Difference in the Burn-out Assesment Tool (Schaufeli et al., 2019) questionnaire score between exposed and control groups. This questionnaire consists of 23 items, each scored from 1 to 5. The sum of the scores for each item is then divided by 23 to give a final score of between 1 and 5. Subjects can then be classified as green (score < 2.59), orange (2.59 to 3.02) and red (score >3.02). The questionnaire contains sub-scores for 'exhaustion', 'mental distance', 'cognitive impairment', 'emotional impairment', 'psychological complaints' and 'psychosomatic complaints'.
Measured: the questionnaire will be completed by the military in April 2025, i.e. 23 months after the start of the crisis for the exposed group
Secondary outcomes (3)
Assessing the impact of the crisis on Burn-out Assesment Tool sub-scores
Comparison of variations in Burn-out Assesment Tool sub-scores (Schaufeli et al., 2020) between the 'exposed' and 'unexposed' groups and the first and second questionnaire two month later. This questionnaire consists of 23 items, each scored from 1 to 5. The sum of the scores for each item is then divided by 23 to give a final score of between 1 and 5. Subjects can then be classified as green (score < 2.59), orange (2.59 to 3.02) and red (score >3.02). The questionnaire contains sub-scores for 'exhaustion', 'mental distance', 'cognitive impairment', 'emotional impairment', 'psychological complaints' and 'psychosomatic complaints'.
Measured: Military personnel will complete the questionnaires in April 2025 and June 2025, i.e. there will be a two-month gap between the two sessions.
Assessing the benefits of raising awareness of organisational and human factors on operational wear and tear
Comparison of variations of the scores of the Burn-out Assesment Tool between the group sensitised to organisational and human factors and the group not sensitised to organisational and human factor on the first and second questionnaires.
This questionnaire consists of 23 items, each scored from 1 to 5. The sum of the scores for each item is then divided by 23 to give a final score of between 1 and 5. Subjects can then be classified as green (score < 2.59), orange (2.59 to 3.02) and red (score >3.02). The questionnaire contains sub-scores for 'exhaustion', 'mental distance', 'cognitive impairment', 'emotional impairment', 'psychological complaints' and 'psychosomatic complaints'.
Measured: Military personnel will complete the questionnaires in April 2025 and June 2025, i.e. there will be a two-month gap between the two sessions.
Determining the protective and vulnerability factors (such as Psychosocial Risks) to operational wear and tear
Search for correlations between scores on the Copenhagen Psychosocial Questionnaire (Kristensen et al., 2005) and Burn-out Assesment Tool scores. Burn-out Assesment Tool questionnaire consists of 23 items, each scored from 1 to 5. The sum of the scores for each item is then divided by 23 to give a final score of between 1 and 5. Subjects can then be classified as green (score < 2.59), orange (2.59 to 3.02) and red (score >3.02). The questionnaire contains sub-scores for 'exhaustion', 'mental distance', 'cognitive impairment', 'emotional impairment', 'psychological complaints' and 'psychosomatic complaints'. The Copenhagen Psychosocial Questionnaire consists of 22 items, each scored from 1 to 5. The sum of the scores for each item is then divided by 22 to give a final score of between 1 and 5. 1 is the best outcome, 5 is the worth outcome.
Measured: Military personnel will complete the questionnaires in April 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start3 Apr 2025
- Primary completionJul 2025 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Stress DisorderStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Direction Centrale du Service de Santé des Armées
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de recherche biomédicale des armées (IRBA), Bretigny sur Orge, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06907030
- Sponsor's protocol ID
- 2024PPRC08
- Other IDs
- 2024-A02433-44
- Acronym
- U-CARE
- Status last verified
- Apr 2025
- First submitted
- 13 Mar 2025
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jaspers GJ, Borsci S, van der Hoeven JG, Kuijer-Siebelink W, Lemson J. Escape room design in training crew resource management in acute care: a scoping review. BMC Med Educ. 2024 Jul 30;24(1):819. doi: 10.1186/s12909-024-05753-z.
PubMed 39080688Kristensen TS, Hannerz H, Hogh A, Borg V. The Copenhagen Psychosocial Questionnaire--a tool for the assessment and improvement of the psychosocial work environment. Scand J Work Environ Health. 2005 Dec;31(6):438-49. doi: 10.5271/sjweh.948.
PubMed 16425585Ramdani C, Desruelle AV, Vallee N, Ogier M. Neurofilament-light: Impact of chronic stress on brain. Rev Neurol (Paris). 2024 Dec;180(10):1139-1141. doi: 10.1016/j.neurol.2024.08.001. Epub 2024 Sep 10. No abstract available.
PubMed 39261122Schaufeli WB, Desart S, De Witte H. Burnout Assessment Tool (BAT)-Development, Validity, and Reliability. Int J Environ Res Public Health. 2020 Dec 18;17(24):9495. doi: 10.3390/ijerph17249495.
PubMed 33352940Klein O., Marchal C. et Van der Linden N. (2008). L'analyse de médiation en psychologie sociale expérimentale : une introduction non technique. Revue électronique de Psychologie Sociale, n°2, pp. 53-62
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Operational Wear and Tear Related to the Caledonian Crisis on Military Personnel
- ClinicalTrials.gov ID
- NCT06907030
- Acronym / sponsor ID
- U-CARE / 2024PPRC08
- Conditions
- Chronic Stress Disorder
- Keywords
- operational wear and tear, resilience, organisational and human factor, psychosocial risk
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Direction Centrale du Service de Santé des ArméesUniversity, hospital or other
- Collaborators
- Institut de recherche biomédicale des armées (IRBA), Bretigny sur Orge, France
- Study start
- 3 Apr 2025 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 2 Apr 2025 (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.
Since May 2024, New Caledonia has been experiencing a period of crisis. The organisation of the work of military personnel on the ground has been heavily impacted, with longer working hours, shorter rest periods and increased stress levels (uncertainty about the situation, lack of visibility, etc.).
Prolonged exposure to stress is accompanied by neuronal damage (Ramdani et al., 2024) and operational fatigue, a mindset that results from reversible neuronal damage and appears to be distinct from exhaustion. The aim of this study is to assess the impact of the crisis on the level of operational fatigue. In addition, identifying the organisational and human factors (Jaspers et al., 2024) that may have been protective against operational fatigue could help to optimise the way in which these factors are taken into account in the event of future crises, in order to promote resilience.
Detailed description
Military personnel face specific operational constraints related to their activity. These constraints require physiological adaptation, which can lead to overall biological wear and tear. In our case, the term 'operational wear and tear' refers to the mindset or mental state induced by operational constraints and the chronic stress they impose.
The soldiers deployed in New Caledonia since the riots in May 2024 have had to cope with operational constraints linked to their job, as well as those linked to the insurrection situation. By modifying the physical constraints (longer working hours, less sleep, etc.) and psychological constraints (for example, the unknown duration of the crisis), the current crisis in New Caledonia may have increased operational wear and tear.
The investigators hypothesise that soldiers present in New Caledonia when the riots began have accumulated additional stress related to the crisis and that this could result in greater operational wear and tear than soldiers transferred to New Caledonia in the summer of 2024. However, it is possible that the stress of moving to New Caledonia will counterbalance this effect. For this reason, the study is being conducted over 2 months, in order to assess the evolutionary profile of operational wear and tear.
This is a single-centre observational study of healthy military personnel in New Caledonia. Subjects will be volunteers and their participation or non-participation will not influence their ability to serve, their promotion or their career. Their superiors will not be informed of their participation or non-participation.
Military personnel will be given an oral presentation of the study. On this occasion, the information note will be distributed to them. If they are volunteers, they will have an inclusion visit, notify their non-objection and fill in the first questionnaire. Between two months later, they will complete the second questionnaire.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exposed group | – | Other: No interventionExposed group is the group of military personnel present in New Caledonia at the start of the crisis, i.e. in May 2024, and still posted to New Caledonia at the time of the study, i.e. in April 2025. |
| control group | – | –Control group is the group of military personnel not present in New Caledonia at the start of the crisis, i.e. in May 2024, posted to New Caledonia in the summer of 2024 and present at the time of the study, i.e. in April 2025. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Serving military personnel aged between 18 and 65 posted to New Caledonia at the time of the study, i.e. between April and July 2025.
Key inclusion criteria (2 listed)
- be a member of the military
- be permanently posted to NC at the time of the study
Key exclusion criteria (6 listed)
- Be on temporary assignment in NC at the time of the study
- Subjects covered by articles L1121-5 to 1121-8 of the Public Health Code, i.e. :
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 |
|---|---|---|
| No interventionNo intervention | Other | exposed group |
Primary outcome
Assessing operational wear and tear linked to the crisis
Time frame: the questionnaire will be completed by the military in April 2025, i.e. 23 months after the start of the crisis for the exposed group
Difference in the Burn-out Assesment Tool (Schaufeli et al., 2019) questionnaire score between exposed and control groups. This questionnaire consists of 23 items, each scored from 1 to 5. The sum of the scores for each item is then divided by 23 to give a final score of between 1 and 5. Subjects can then be classified as green (score < 2.59), orange (2.59 to 3.02) and red (score >3.02). The questionnaire contains sub-scores for 'exhaustion', 'mental distance', 'cognitive impairment', 'emotional impairment', 'psychological complaints' and 'psychosomatic complaints'.
3 secondary outcomes
Assessing the impact of the crisis on Burn-out Assesment Tool sub-scores
Time frame: Military personnel will complete the questionnaires in April 2025 and June 2025, i.e. there will be a two-month gap between the two sessions.
Assessing the benefits of raising awareness of organisational and human factors on operational wear and tear
Time frame: Military personnel will complete the questionnaires in April 2025 and June 2025, i.e. there will be a two-month gap between the two sessions.
Determining the protective and vulnerability factors (such as Psychosocial Risks) to operational wear and tear
Time frame: Military personnel will complete the questionnaires in April 2025
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Background: PubMed 39080688Jaspers GJ, Borsci S, van der Hoeven JG, Kuijer-Siebelink W, Lemson J. Escape room design in training crew resource management in acute care: a scoping review. BMC Med Educ. 2024 Jul 30;24(1):819. doi: 10.1186/s12909-024-05753-z.
- Background: PubMed 16425585Kristensen TS, Hannerz H, Hogh A, Borg V. The Copenhagen Psychosocial Questionnaire--a tool for the assessment and improvement of the psychosocial work environment. Scand J Work Environ Health. 2005 Dec;31(6):438-49. doi: 10.5271/sjweh.948.
- Background: PubMed 39261122Ramdani C, Desruelle AV, Vallee N, Ogier M. Neurofilament-light: Impact of chronic stress on brain. Rev Neurol (Paris). 2024 Dec;180(10):1139-1141. doi: 10.1016/j.neurol.2024.08.001. Epub 2024 Sep 10. No abstract available.
- Background: PubMed 33352940Schaufeli WB, Desart S, De Witte H. Burnout Assessment Tool (BAT)-Development, Validity, and Reliability. Int J Environ Res Public Health. 2020 Dec 18;17(24):9495. doi: 10.3390/ijerph17249495.
- BackgroundKlein O., Marchal C. et Van der Linden N. (2008). L'analyse de médiation en psychologie sociale expérimentale : une introduction non technique. Revue électronique de Psychologie Sociale, n°2, pp. 53-62
- 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.
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 Chronic Stress Disorder, run by Direction Centrale du Service de Santé des Armées 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 2 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 9 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact celine ramdani, MD (0662194297, celineramdani@hotmail.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing operational wear and tear linked to the crisis (time frame: the questionnaire will be completed by the military in April 2025, i.e. 23 months after the start of the crisis for the exposed group). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06907030, which also lists 5 linked publications.
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 9 Apr 2025.