PTSDDstressNCT06796556
Evaluation of an Algorithm for the Identification of Post-traumatic Stress Disorder
An observational study of PTSD, run by Direction Centrale du Service de Santé des Armées at 1 site in France.
Trial summary
Post-traumatic stress disorder (PTSD) develops after a threat for oneself and/or others. It is frequent, particularly in the military, due to repeated exposure to traumatic events. The prevalence is estimated between 35 and 75% in military. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- PTSD
- What is being tested?
- virtual reality exposition
- Type of treatment
- Medical device
- How many people
- 134 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jun 2022to 31 Jan 2023
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: The number of subjects needed per group is 20 or 80 subjects in total, to account for potential false negatives. This estimate is based on data from the few previous published studies using virtual reality to characterize the physiological responses of military personnel to various types of stimuli and thus to separate subjects (PTSD, sub-clinical PTSD and unaffected). The physiological measures used in our study are those from this literature (electrodermal conductance and heart rate) enriched with electroencephalographic recordings and behavioral biomarkers of interest because of their sensitivity described in the literature to emotional responses.
Who may be able to join
- military
- operational (fit to serve)
- men
- voluntary
- medical insurance
Who cannot join
- not military
- with medical or psychological suffering (other than PTSD or alcohol abuse)
- To develop and evaluate the robustness of a clinically constituted PTSD detection score
- not able to virtual reality
Trial locations and contacts
1 site in 1 country.
About this study
Post-traumatic stress disorder (PTSD) develops after a threat for oneself and/or others. It is frequent, particularly in the military, due to repeated exposure to traumatic events. The prevalence is estimated between 35 and 75% in military.
It is essential to detect PTSD, whether it is present or sub-clinical, as early as possible, both from an individual point of view (maintaining the health of the soldier) and from a collective point of view (maintaining the operational status). Early detection is ²necessary for the implementation of early management strategies to reduce the significant risk of chronicization (around 80%), which can then be associated with severe complications such as addictions and suicide. The stakes of detecting PTSD are also at the collective level with the maintenance of operational capacity, under optimal performance and safety conditions (e.g.: risk of decompensation in the field with repercussions on the safety of the group and the progress of the mission).
Read more
However, the current methods of detecting PTSD (constituted or sub-clinical) is a clinical interview which can be associated with the use of the Clinical Administration PTSD for DSM -5 (CAPS) filled in by the clinician, or the self-reported questionnaires such as the Post-Traumatic CheckList Scale (PCL-5). It has many limitations, particularly due to the fear of stigmatization, which is greater in this professional context. Moreover, for sub-clinical PTSD, these tools are insufficient.
There is therefore a real need to develop screening tools for PTSD for soldiers that 1) are sensitive and specific (effectiveness), 2) are objective and do not depend on the answers given to a questionnaire (reliability), 3) can be implemented systematically on large samples (systematization), 4) do not depend on the soldier's spontaneous request for a health professional, and 5) are acceptable to the soldier (adherence). This need exists for constituted PTSD as well as for sub-clinical PTSD and constitutes a prerequisite for the implementation of early management (prevention of the risks of chronicization).
In view of the current data, PTSD can be considered as an emotional response (a conditioned fear response) because it is triggered in the absence of a real threat. To detect the presence or absence of PTSD, including sub-clinical PTSD, a proposition was made to characterize this emotional response triggered by exposure to sensory stimuli presented in virtual reality
Read the detailed description
To develop and evaluate the robustness of a clinically constituted PTSD detection score (full PTSD) based on the emotional response, including conditioned fear, triggered by exposure to sensory stimuli presented in virtual reality and characterized by physiological and behavioral measures thus recorded
- Conditions
- PTSD
- Being tested
- virtual reality exposition
- 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.
virtual reality expositionDevice
emotional response triggered by exposure to sensory stimuli presented in virtual reality.
What is being measured
The primary outcome is the main question the study is designed to answer.
physiological score for PTSD
To develop and evaluate the robustness of a clinically constituted PTSD detection score (full PTSD) based on the emotional response, including conditioned fear, triggered by exposure to sensory stimuli presented in virtual reality and characterized by physiological and behavioral measures thus recorded
Measured: one year
Secondary outcomes (1)
physiological score for partial PTSD
To evaluate and optimize the robustness of a clinically partial PTSD detection score
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start10 Jun 2022
- Primary completion31 Jan 2023
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Direction Centrale du Service de Santé des Armées
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06796556
- Sponsor's protocol ID
- 2021-A02717-34
- Acronym
- Dstress
- Status last verified
- Jun 2024
- First submitted
- 30 Nov 2022
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: principal component analyses and algorithmy
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Algorithm for the Identification of Post-traumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT06796556
- Acronym / sponsor ID
- Dstress / 2021-A02717-34
- Conditions
- PTSD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Direction Centrale du Service de Santé des ArméesUniversity, hospital or other
- Study start
- 10 Jun 2022 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 28 Jan 2025 (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) develops after a threat for oneself and/or others. It is frequent, particularly in the military, due to repeated exposure to traumatic events. The prevalence is estimated between 35 and 75% in military.
It is essential to detect PTSD, whether it is present or sub-clinical, as early as possible, both from an individual point of view (maintaining the health of the soldier) and from a collective point of view (maintaining the operational status). Early detection is ²necessary for the implementation of early management strategies to reduce the significant risk of chronicization (around 80%), which can then be associated with severe complications such as addictions and suicide. The stakes of detecting PTSD are also at the collective level with the maintenance of operational capacity, under optimal performance and safety conditions (e.g.: risk of decompensation in the field with repercussions on the safety of the group and the progress of the mission).
However, the current methods of detecting PTSD (constituted or sub-clinical) is a clinical interview which can be associated with the use of the Clinical Administration PTSD for DSM -5 (CAPS) filled in by the clinician, or the self-reported questionnaires such as the Post-Traumatic CheckList Scale (PCL-5). It has many limitations, particularly due to the fear of stigmatization, which is greater in this professional context. Moreover, for sub-clinical PTSD, these tools are insufficient.
There is therefore a real need to develop screening tools for PTSD for soldiers that 1) are sensitive and specific (effectiveness), 2) are objective and do not depend on the answers given to a questionnaire (reliability), 3) can be implemented systematically on large samples (systematization), 4) do not depend on the soldier's spontaneous request for a health professional, and 5) are acceptable to the soldier (adherence). This need exists for constituted PTSD as well as for sub-clinical PTSD and constitutes a prerequisite for the implementation of early management (prevention of the risks of chronicization).
In view of the current data, PTSD can be considered as an emotional response (a conditioned fear response) because it is triggered in the absence of a real threat. To detect the presence or absence of PTSD, including sub-clinical PTSD, a proposition was made to characterize this emotional response triggered by exposure to sensory stimuli presented in virtual reality
Detailed description
To develop and evaluate the robustness of a clinically constituted PTSD detection score (full PTSD) based on the emotional response, including conditioned fear, triggered by exposure to sensory stimuli presented in virtual reality and characterized by physiological and behavioral measures thus recorded
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The number of subjects needed per group is 20 or 80 subjects in total, to account for potential false negatives. This estimate is based on data from the few previous published studies using virtual reality to characterize the physiological responses of military personnel to various types of stimuli and thus to separate subjects (PTSD, sub-clinical PTSD and unaffected). The physiological measures used in our study are those from this literature (electrodermal conductance and heart rate) enriched with electroencephalographic recordings and behavioral biomarkers of interest because of their sensitivity described in the literature to emotional responses.
Key inclusion criteria (5 listed)
- military
- operational (fit to serve)
- men
- voluntary
- medical insurance
Key exclusion criteria (4 listed)
- not military
- with medical or psychological suffering (other than PTSD or alcohol abuse)
- To develop and evaluate the robustness of a clinically constituted PTSD detection score
- not able to virtual reality
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 |
|---|---|---|
| virtual reality expositionemotional response triggered by exposure to sensory stimuli presented in virtual reality. | Device | – |
Primary outcome
physiological score for PTSD
Time frame: one year
To develop and evaluate the robustness of a clinically constituted PTSD detection score (full PTSD) based on the emotional response, including conditioned fear, triggered by exposure to sensory stimuli presented in virtual reality and characterized by physiological and behavioral measures thus recorded
1 secondary outcome
physiological score for partial PTSD
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Individual participant dataSharing planned: Undecided. principal component analyses and algorithmy
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PTSD, 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 4 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: finished, as of the sponsor's last update on 28 Jan 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
physiological score for PTSD (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jan 2025; AzTrials last refreshed its copy on 1 Nov 2026.