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Implementation of a Post-traumatic Stress Disorder PREvention Program Within the French ARmy

Implementation of a Post-traumatic Stress Disorder Primary Prevention Program Within the French Army

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05094531
Acronym
PREPAR
Enrollment
116
Registered
2021-10-26
Start date
2021-04-26
Completion date
2022-05-31
Last updated
2022-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Traumatic Stress Disorder

Keywords

Primary prevention programm, prevention, programm, Biopsychosocial, approach

Brief summary

Post-Traumatic Stress Disorder (PTSD) is a mental health condition that's triggered by a terrifying event perceived as a life threatening - either experiencing it or witnessing it. Lifetime prevalence of PTSD in the European population is between 0.7% and 1.9%. According to the dose-response model, the individuals most exposed to traumatic events (TEs) are those who are most at risk of developing this disorder. This is why it is not surprising to observe a higher prevalence of this disorder in the military population, ranging from 10% to 18% or even 45%, depending on the studies. In the 1980s, the practice of evidence-based preventive medicine (EBM-Evidence Based Medicine) was developed. It involves the conscientious, explicit, judicious and reasonable use of modern, best evidence in making decisions about the care of individual patients. EBM integrates clinical experience and patient values with the best available research information. Health condition prevention includes several levels of action: primary, secondary or tertiary, depending on the timing of the intervention in the course of the disease. The aim of this project is to explore the efficiency of primary prevention actions in strengthening the resilience capacities of at-risk professionals, such as the military, in order to prevent the development of PTSD and to improve it prognosis. The objectives of this project are (i) to design a primary prevention program for PTSD specific to the military population studied and compatible with the operational constraints of field soldiers, (ii) then, to implement / validate it within the operational staff of the Mountain Infantry Brigade (MIB). Our approach is based on an integrative reading of the processes in the risk of developing PTSD. This biopsychosocial approach targets both the factors specific to the individual (on the physiological and psychological level) and the contextual and social factors relating to his professional environment. Three dimensions are addressed: (i) biophysiology (by integrating the study of key biomarkers of the neurobiological response to stress, and by strengthening the flexibility of the autonomic nervous system), (ii) psychology (by facilitating and measuring the development of the flexibility of coping strategies to cope with stress as well as by evaluating the moderating role of the sense mission in the development of PTSD) and (iii) the social (by facilitating community strategies aimed at reducing stigmatization and facilitating the use of care for professionals in difficulty in the institutional context).

Interventions

OTHERPrimary prevention programm

This programm aims to adress three dimensions : (i) biophysiology (flexibility of the autonomic nervous system), (ii) psychology (flexibility of coping strategies, sens of mission) and (iii) the social (stigmatization, seeking health care).

Sponsors

Urgotech
CollaboratorINDUSTRY
Direction Centrale du Service de Santé des Armées
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Masking description

none since it is an open label

Eligibility

Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Social security affiliation * Combat unit soldier with certificate of military efficiency * With at least a 12-months employment contract within the MIB * Able to attend all the workshops * Not member of the Groupement Commando de Montagne

Exclusion criteria

* Participant of the PREPAR Phase 1 * Under chronic medication (daily treatment for at least a month) * Unwilling to participate * With a overseas deployment scheduled within the next 12 months * Adult persons subject to a legal protection measure

Design outcomes

Primary

MeasureTime frameDescription
Effectiveness of the prevention program in improving resilience at the end of the propgrammAfter the completion of the programm, up to 50 weeksComposite primary endpoint. Significant improvement of resilience will be achieved if 2 or the following 3 criteria are meet: * 20% increase of the PANAS score (Positive And Negative Affect Schedule) * 20% score improvement of the SCS score (Self-Compassion Scale) * 5% score improvement of DRS-15 (Dispositional Resilience Scale)

Secondary

MeasureTime frameDescription
Follow-up evaluation of the resilience scoreTwo and six months after the completion of the prevention programComposite endpoint. Significant improvement of resilience will be achieved if 2 or the following 3 criteria are meet: * 20% increase of the PANAS score (Positive And Negative Affect Schedule) * 20% score improvement of the SCS score (Self-Compassion Scale) * 5% score improvement of DRS-15 (Dispositional Resilience Scale)

Countries

France

Contacts

Primary ContactAnaïs Duffaud, PhD
anais.duffaud@def.gouv.fr0618942117
Backup ContactMarion Trousselard, PhD, MD
marion.trousselard@gmail.com0178651255

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026