Clinical trial NCT05094531: Implementation of a Post-traumatic Stress Disorder PREvention Program Within the French ARmy
Official title: Implementation of a Post-traumatic Stress Disorder Primary Prevention Program Within the French Army
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post Traumatic Stress Disorder
Keywords: Primary prevention programm
prevention
programm
Biopsychosocial
approach
Lead sponsor: Direction Centrale du Service de Santé des Armées
Sponsor class: OTHER
Collaborators: name: Urgotech
First posted: 2021-10-26
Enrollment: 116
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


Eligibility criteria: 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

Primary outcomes:
measure: Effectiveness of the prevention program in improving resilience at the end of the propgramm
timeFrame: After the completion of the programm, up to 50 weeks
Secondary outcomes:
measure: Follow-up evaluation of the resilience score
timeFrame: Two and six months after the completion of the prevention program
Other outcomes:
Locations:
city: Varces-Allières-et-Risset
country: France
facility: 27 BIM
Study officials:
References: