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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Post Traumatic Stress Disorder
• Intervention / Treatment: Other: Primary prevention programm

• Study Type: Interventional
• Enrollment (Anticipated): 116
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anaïs Duffaud, PhD; Phone Number: 0618942117; Email: anais.duffaud@def.gouv.fr
• Study Contact Backup: Name: marion Trousselard, PhD, MD; Phone Number: 0178651255; Email: marion.trousselard@gmail.com

Study Locations

• France
  • Varces-Allières-et-Risset, France, 38760
    • Recruiting
    • 27 BIM
    • Contact: Anaïs Duffaud, PhD; Phone Number: 0618942117; Email: anais.duffaud@def.gouv.fr
    • Contact: marion Trousselard, PhD, MD; Phone Number: 0178651255; Email: marion.trousselard@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention group; Participants of this experimental group will have to attend the prevention program which is organised in eight 2-hour workshops, one every other week. Groups of 10-12 participants will be established prior to the first session of the program and will remain the same throughout the program.	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).
NO_INTERVENTION: No-intervention group; Participants of the no-intervention group will not have to attend the prevention program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Direction Centrale du Service de Santé des Armées
• Collaborators: Urgotech

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 26, 2021
• Primary Completion (ANTICIPATED): May 29, 2022
• Study Completion (ANTICIPATED): May 31, 2022

Study Registration Dates

• First Submitted: April 26, 2021
• First Submitted That Met QC Criteria: October 14, 2021
• First Posted (ACTUAL): October 26, 2021

Study Record Updates

• Last Update Posted (ACTUAL): April 7, 2022
• Last Update Submitted That Met QC Criteria: April 6, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: prevention; Biopsychosocial; approach; Primary prevention programm; programm
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 2020PBMD03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No