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Completed

NCT Number: NCT06796556

Evaluation of an Algorithm for the Identification of Post-traumatic Stress Disorder

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

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Key information

Age range

18 year–65 year

Sex eligibility

Male

Study type

Observational

Primary location

DCSSA

Paris, Not in US/Canada, 75015, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • military
  • operational (fit to serve)
  • men
  • voluntary
  • medical insurance

Exclusion criteria

  • 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

Treatment and study plan

virtual reality exposition

Device

emotional response triggered by exposure to sensory stimuli presented in virtual reality.

Primary outcomes

  1. 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

Secondary outcomes

  1. physiological score for partial PTSD

    Time frame: one year

    To evaluate and optimize the robustness of a clinically partial PTSD detection score

Sponsors and collaborators

Lead sponsor

Direction Centrale du Service de Santé des Armées

Other

Registry information

Acronym: Dstress

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 28, 2025
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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