Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:37 PM
Study NCT ID:
NCT04518267
Status:
UNKNOWN
Last Update Posted:
2023-04-28
First Post:
2020-08-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Anger and Psychotrauma: Data From Military and Civilians
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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-09-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-27', 'studyFirstSubmitDate': '2020-08-15', 'studyFirstSubmitQcDate': '2020-08-15', 'lastUpdatePostDateStruct': {'date': '2023-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anxiety score', 'timeFrame': 'At enrollment', 'description': "Spielberger's State-Trait Anger Expression Inventory-II (STAXI-II) will be used to assess anxiety"}, {'measure': 'PTSD severity score', 'timeFrame': 'At enrollment', 'description': 'Clinician-Administered Posttraumatic Stress Disorder Scale (CAPS-5) will be used to assess PTSD severity score. CAPS-5 score may range from 0 to 120 with higher scores meaning greater PTSD severity.'}, {'measure': 'Number of life traumatic events', 'timeFrame': 'At enrollment', 'description': 'Life Event Checklist (LEC) will be used to assess the number of traumatic events experienced by participants throughout their lifetime'}], 'secondaryOutcomes': [{'measure': 'Aggressivity score', 'timeFrame': 'At enrollment', 'description': 'Aggressivity Questionnaire (AQ12) will be used to assess aggressivity score. AQ12 score may range from 6 to 72 with higher scores meaning higher aggressivity levels.'}, {'measure': 'Anger Rumination score', 'timeFrame': 'At enrollment', 'description': 'Anger Rumination Scale (ARS) will be used to assess anger rumination score. ARS score may range from 19 to 76 with higher scores corresponding to greater levels of anger rumination.'}, {'measure': 'Alcohol consumption score', 'timeFrame': 'At enrollment', 'description': 'Alcohol Use Identification Test (A.U.D.I.T.) will be used to assess alcohol consumption score Score ≥ 5: at risk use; Score ≥ 8 (7 in women): harmful use; Score ≥ 12 (11 in women): likely alcohol dependence'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post-traumatic Stress Disorder']}, 'descriptionModule': {'briefSummary': 'Post-Traumatic Stress Disorder (PTSD) is mainly associated with several emotions such as anger, guilt or shame. By interfering with psychotherapeutic work these emotions can be problematic. When suffering from PTSD, pervasive anger can also have relational consequences. Anger and PTSD are mutually reinforcing: anger can aggravate PTSD symptoms and aggressive behaviours, and conversely, PTSD promotes high levels of anger and aggression. A few explanatory hypotheses have been proposed. In terms of personality factors, anger-treatment may promote the severity of PTSD symptoms and the development of aggressive behaviours. In terms of stressors, exposure to combat and combat-related moral harms could play a role in the relationship between PTSD, anger and traumatic experiences over the course of life. Finally, in clinical terms, in the presence of PTSD, anger and aggressive behaviours may be triggered by substance abuse and depression.\n\nWithin the Anglo-Saxon literature, it is recognized that both civilians and military personnel with PTSD exhibit high levels of anger, with a possible predominance among military personnel. While we know that anger management mechanisms can be strongly influenced by cultural aspects and the type of event, there is no data in the French population.\n\nThis study proposes to fill in our knowledge of anger-PSTD relationships in the French population and by comparing civilian and military population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will be composed of participants suffering from PTSD, half of which will have civilian status and the other half a military status.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* To have a PTSD diagnosis\n* To be at least 18 years of age\n\nExclusion Criteria:\n\n* To suffer from trauma-related physical condition (including Traumatic Brain Injury)'}, 'identificationModule': {'nctId': 'NCT04518267', 'acronym': 'COPMiCiv', 'briefTitle': 'Anger and Psychotrauma: Data From Military and Civilians', 'organization': {'class': 'OTHER', 'fullName': 'Direction Centrale du Service de Santé des Armées'}, 'officialTitle': 'Anger and Psychotrauma: Data From Military and Civilians', 'orgStudyIdInfo': {'id': '2019PPRC16'}, 'secondaryIdInfos': [{'id': '2020-A00507-32', 'type': 'OTHER', 'domain': 'IDRCB'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Civilian group', 'description': 'Participants with civilian status', 'interventionNames': ['Behavioral: Structured clinical interview', 'Behavioral: Psychological questionnaires']}, {'label': 'Military group', 'description': 'Participants with military status', 'interventionNames': ['Behavioral: Structured clinical interview', 'Behavioral: Psychological questionnaires']}], 'interventions': [{'name': 'Structured clinical interview', 'type': 'BEHAVIORAL', 'description': 'A structured clinical interview will be performed at enrollment.', 'armGroupLabels': ['Civilian group', 'Military group']}, {'name': 'Psychological questionnaires', 'type': 'BEHAVIORAL', 'description': 'Several psychological questionnaires will be performed at enrollment.', 'armGroupLabels': ['Civilian group', 'Military group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '62000', 'city': 'Arras', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Laure ROUGEGREZ, MD', 'role': 'CONTACT', 'email': 'laure.rougegrez@gh-artoisternois.fr', 'phone': '321211070', 'phoneExt': '+33'}], 'facility': "Centre hospitalier d'Arras", 'geoPoint': {'lat': 50.29301, 'lon': 2.78186}}, {'zip': '59000', 'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Frédérique WAREMBOURG, MD', 'role': 'CONTACT', 'email': 'frederique.warembourg@chru-lille.fr', 'phone': '320445557', 'phoneExt': '+33'}], 'facility': 'Centre régional psychotrauma Hauts-de-France', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '59001', 'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anais MARMUSE', 'role': 'CONTACT', 'email': 'anais.marmuse@intradef.gouv.fr', 'phone': '328382250', 'phoneExt': '+33'}], 'facility': '3ème Centre médical des Armées', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '33310', 'city': 'Lormont', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Samantha AL JOBOORY, MD', 'role': 'CONTACT', 'email': 'samantha.aljoboory@ch-cadillac.fr'}], 'facility': 'Centre Hospitalier de Cadillac', 'geoPoint': {'lat': 44.8765, 'lon': -0.51919}}, {'zip': '06001', 'city': 'Nice', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jérémy BRIDE', 'role': 'CONTACT', 'email': 'bride.j@chu-nice.fr', 'phone': '692033335', 'phoneExt': '+33'}], 'facility': 'CHU de Nice', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '06200', 'city': 'Nice', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Morgane GINDT', 'role': 'CONTACT', 'email': 'morgane.gindt@hpu.lenval.com', 'phone': '492030066', 'phoneExt': '+33'}], 'facility': 'CHU-Lenval hôpitaux', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '66301', 'city': 'Thuir', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Philippe RAYNAUD, MD', 'role': 'CONTACT', 'email': 'philippe.raynaud@ch-thuir.fr', 'phone': '468846620', 'phoneExt': '+33'}], 'facility': 'Centre Hospitalier Léon-Jean Grégory de Thuir', 'geoPoint': {'lat': 42.6322, 'lon': 2.75577}}, {'zip': '94806', 'city': 'Villejuif', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Claire GRANIER, MD', 'role': 'CONTACT', 'email': 'granier.claire@hotmail.fr', 'phone': '142117230', 'phoneExt': '+33'}], 'facility': 'Groupe Hospitalier Paul Guiraud', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'centralContacts': [{'name': 'Anaïs MARMUSE', 'role': 'CONTACT', 'email': 'anais.marmuse@intradef.gouv.fr', 'phone': '328382250', 'phoneExt': '+33'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Direction Centrale du Service de Santé des Armées', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}