Post Traumatic Stress DisorderPREPARNCT05094531
Implementation of a Post-traumatic Stress Disorder PREvention Program Within the French ARmy
A study testing Primary prevention programm in people with Post Traumatic Stress Disorder, run by Direction Centrale du Service de Santé des Armées at 1 site in France.
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%. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- Primary prevention programm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteFrance
- Study dates
- 26 Apr 2021to 31 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
27 BIM
Varces-Allières-et-Risset, 38760
Anaïs Duffaud, PhD, 0618942117, anais.duffaud@def.gouv.fr
marion Trousselard, PhD, MD, 0178651255, marion.trousselard@gmail.com
About this study
Official title: 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.
Read more
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
- Being tested
- Primary prevention programm
- Keywords
- Primary prevention programm, prevention, programm, Biopsychosocial, approach
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary prevention programmOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Primary prevention programm |
| No-intervention group | No intervention | Participants of the no-intervention group will not have to attend the prevention program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: After the completion of the programm, up to 50 weeks
Secondary outcomes (1)
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)
Measured: Two and six months after the completion of the prevention program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start26 Apr 2021
- Primary completion29 May 2022 (estimated)
- Study completion31 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Direction Centrale du Service de Santé des Armées
- Sponsor type
- University, hospital or other
- Collaborators
- Urgotech
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05094531
- Sponsor's protocol ID
- 2020PBMD03
- Acronym
- PREPAR
- Status last verified
- Apr 2022
- First submitted
- 26 Apr 2021
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38277204
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Post-traumatic Stress Disorder Primary Prevention Program Within the French Army
- ClinicalTrials.gov ID
- NCT05094531
- Acronym / sponsor ID
- PREPAR / 2020PBMD03
- Conditions
- Post Traumatic Stress Disorder
- Keywords
- Primary prevention programm, prevention, programm, Biopsychosocial, approach
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Direction Centrale du Service de Santé des ArméesUniversity, hospital or other
- Collaborators
- Urgotech
- Study start
- 26 Apr 2021 (actual)
- Primary completion
- 29 May 2022 (estimated)
- Study completion
- 31 May 2022 (estimated)
- First posted
- 26 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Primary prevention programmParticipants 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. |
| No-intervention group | No intervention | –Participants of the no-intervention group will not have to attend the prevention program. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Primary prevention programmThis 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). | Other | Intervention group |
Primary outcome
Effectiveness of the prevention program in improving resilience at the end of the propgramm
Time frame: After the completion of the programm, up to 50 weeks
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)
1 secondary outcome
Follow-up evaluation of the resilience score
Time frame: Two and six months after the completion of the prevention program
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Derived from this study: PubMed 38277204Le 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primary prevention programm in people with Post Traumatic Stress Disorder, run by Direction Centrale du Service de Santé des Armées at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anaïs Duffaud, PhD (0618942117, anais.duffaud@def.gouv.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of the prevention program in improving resilience at the end of the propgramm (time frame: After the completion of the programm, up to 50 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05094531, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2022.