Ignite Creation Date:
2025-12-24 @ 11:21 PM
Ignite Modification Date:
2025-12-25 @ 9:04 PM
Study NCT ID:
NCT06796556
Status:
COMPLETED
Last Update Posted:
2025-01-28
First Post:
2022-11-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of an Algorithm for the Identification of Post-traumatic Stress Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 134}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-27', 'studyFirstSubmitDate': '2022-11-30', 'studyFirstSubmitQcDate': '2025-01-27', 'lastUpdatePostDateStruct': {'date': '2025-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'physiological score for PTSD', 'timeFrame': 'one year', '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'}], 'secondaryOutcomes': [{'measure': 'physiological score for partial PTSD', 'timeFrame': 'one year', 'description': 'To evaluate and optimize the robustness of a clinically partial PTSD detection score'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['PTSD']}, 'descriptionModule': {'briefSummary': "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.\n\nIt 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).\n\nHowever, 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.\n\nThere 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).\n\nIn 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", 'detailedDescription': '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'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The number of subjects needed per group is 20 or 80 subjects in total, to account for potential false negatives.\n\nThis 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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* military\n* operational (fit to serve)\n* men\n* voluntary\n* medical insurance\n\nExclusion Criteria:\n\n* not military\n* with medical or psychological suffering (other than PTSD or alcohol abuse)\n* To develop and evaluate the robustness of a clinically constituted PTSD detection score\n* not able to virtual reality'}, 'identificationModule': {'nctId': 'NCT06796556', 'acronym': 'Dstress', 'briefTitle': 'Evaluation of an Algorithm for the Identification of Post-traumatic Stress Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Direction Centrale du Service de Santé des Armées'}, 'officialTitle': 'Evaluation of an Algorithm for the Identification of Post-traumatic Stress Disorder', 'orgStudyIdInfo': {'id': '2021-A02717-34'}}, 'armsInterventionsModule': {'interventions': [{'name': 'virtual reality exposition', 'type': 'DEVICE', 'description': 'emotional response triggered by exposure to sensory stimuli presented in virtual reality.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75015', 'city': 'Paris', 'state': 'Not in US/Canada', 'country': 'France', 'facility': 'DCSSA', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'principal component analyses and algorithmy'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Direction Centrale du Service de Santé des Armées', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}