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

Post Traumatic Stress Disorder Clinical Trial

— PREPAR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05094531
• Other study ID #: 2020PBMD03
• Status: Recruiting
• Phase: N/A
• Start date: April 26, 2021
• Est. completion date: May 31, 2022

Study information

• Verified date: April 2022
• Source: Direction Centrale du Service de Santé des Armées
• Contact: Anaïs Duffaud, PhD
• Phone: 0618942117
• Email: anais.duffaud[@]def.gouv.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 116
• Est. completion date: May 31, 2022
• Est. primary completion date: May 29, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Other:
• Primary 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).

Locations

Country	Name	City	State
France	27 BIM	Varces-Allières-et-Risset

Sponsors (2)

Lead Sponsor	Collaborator
Direction Centrale du Service de Santé des Armées	Urgotech

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of the prevention program in improving resilience at the end of the propgramm	Composite 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)	After the completion of the programm, up to 50 weeks
Secondary	Follow-up evaluation of the resilience score	Composite 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)	Two and six months after the completion of the prevention program