Implementation of a Post-traumatic Stress Disorder PREvention Program Within the French ARmy (PREPAR)
Primary Purpose
Post Traumatic Stress Disorder
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Primary prevention programm
Sponsored by
About this trial
This is an interventional prevention trial for Post Traumatic Stress Disorder focused on measuring Primary prevention programm, prevention, programm, Biopsychosocial, approach
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
Sites / Locations
- 27 BIMRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
No-intervention group
Arm Description
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.
Participants of the no-intervention group will not have to attend the prevention program.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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)
Full Information
NCT ID
NCT05094531
First Posted
April 26, 2021
Last Updated
April 6, 2022
Sponsor
Direction Centrale du Service de Santé des Armées
Collaborators
Urgotech
1. Study Identification
Unique Protocol Identification Number
NCT05094531
Brief Title
Implementation of a Post-traumatic Stress Disorder PREvention Program Within the French ARmy
Acronym
PREPAR
Official Title
Implementation of a Post-traumatic Stress Disorder Primary Prevention Program Within the French Army
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 26, 2021 (Actual)
Primary Completion Date
May 29, 2022 (Anticipated)
Study Completion Date
May 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Direction Centrale du Service de Santé des Armées
Collaborators
Urgotech
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder
Keywords
Primary prevention programm, prevention, programm, Biopsychosocial, approach
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
none since it is an open label
Allocation
Randomized
Enrollment
116 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
No-intervention group
Arm Type
No Intervention
Arm Description
Participants of the no-intervention group will not have to attend the prevention program.
Intervention Type
Other
Intervention Name(s)
Primary prevention programm
Intervention Description
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).
Primary Outcome Measure Information:
Title
Effectiveness of the prevention program in improving resilience at the end of the propgramm
Description
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)
Time Frame
After the completion of the programm, up to 50 weeks
Secondary Outcome Measure Information:
Title
Follow-up evaluation of the resilience score
Description
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)
Time Frame
Two and six months after the completion of the prevention program
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anaïs Duffaud, PhD
Phone
0618942117
Email
anais.duffaud@def.gouv.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Marion Trousselard, PhD, MD
Phone
0178651255
Email
marion.trousselard@gmail.com
Facility Information:
Facility Name
27 BIM
City
Varces-Allières-et-Risset
ZIP/Postal Code
38760
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anaïs Duffaud, PhD
Phone
0618942117
Email
anais.duffaud@def.gouv.fr
First Name & Middle Initial & Last Name & Degree
marion Trousselard, PhD, MD
Phone
0178651255
Email
marion.trousselard@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Implementation of a Post-traumatic Stress Disorder PREvention Program Within the French ARmy
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