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

NCT05094531 | Unknown

• 1 other identifier: 2020PBMD03
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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).

Conditions

Post Traumatic Stress Disorder

Keywords

Primary prevention programm; prevention; programm; Biopsychosocial; approach

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Follow-up evaluation of the resilience score

  Two and six months after the completion of the prevention program

Study Arms (2)

Intervention group

EXPERIMENTAL

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

No-intervention group

NO INTERVENTION

Participants of the no-intervention group will not have to attend the prevention program.

Interventions

Primary prevention programm OTHER

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).

Intervention group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Direction Centrale du Service de Santé des Armées: lead
• Urgotech: collaborator

Study Sites (1)

27 BIM

Varces-Allières-et-Risset, 38760, France

RECRUITING

Related Publications (1)

• Le Barbenchon E, Trousselard M, Pellissier S, Moisseron-Baude M, Chachignon P, Bouny P, Toure Cuq E, Jacob S, Vigier C, Hidalgo M, Claverie D, Duffaud AM. Implementation of a Primary Prevention Program for Posttraumatic Stress Disorder in a Cohort of Professional Soldiers (PREPAR): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Jan 26;13:e47175. doi: 10.2196/47175.

  PMID: 38277204 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Central Study Contacts

Anaïs Duffaud, PhD

CONTACT

0618942117; anais.duffaud@def.gouv.fr

Marion Trousselard, PhD, MD

CONTACT

0178651255; marion.trousselard@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: none since it is an open label
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: October 26, 2021
• Study Start: April 26, 2021
• Primary Completion: May 29, 2022
• Study Completion: May 31, 2022
• Last Updated: April 7, 2022

Record last verified: 2022-04

Locations

FR (1)