Ignite Creation Date:
2025-12-24 @ 4:47 PM
Ignite Modification Date:
2026-02-25 @ 9:44 PM
Study NCT ID:
NCT05026450
Status:
COMPLETED
Last Update Posted:
2024-06-18
First Post:
2021-08-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploring the Psycho-traumatic Impact of a Violent Act Commited at the Bordeaux-Gradignan Penitentiary Center
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': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-17', 'studyFirstSubmitDate': '2021-08-17', 'studyFirstSubmitQcDate': '2021-08-23', 'lastUpdatePostDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Explore whether Post-Traumatic Stress Disorder develops as a result of a violent act committed.', 'timeFrame': '1 month', 'description': 'Evaluation of Post-traumatic stress disorder using the PTSD self-report scale: PCL-5, with a cut-off value of 38 to indicate the presence of a diagnosis of PTSD.'}], 'secondaryOutcomes': [{'measure': 'Identify risk factors that may have contributed to the onset of symptoms of post-traumatic stress disorder', 'timeFrame': 'Baseline', 'description': 'Socio-demographic data, personnal and medical history'}, {'measure': 'Identify risk factors that may have contributed to the maintenance of symptoms of post-traumatic stress disorder', 'timeFrame': '1 month', 'description': 'Socio-demographic data, personnal and medical history'}, {'measure': 'Frequency of post-traumatic stress disorder according to the various factors that may have contributed to its onset', 'timeFrame': '1 month', 'description': 'Age, sex, length of time since the offense, possible link with the victim, history of psychiatric follow-up and history of exposure to other traumatic events'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post Traumatic Stress Disorder', 'Offensive Aggression', 'Violent Behavior']}, 'referencesModule': {'references': [{'pmid': '28385165', 'type': 'BACKGROUND', 'citation': 'Koenen KC, Ratanatharathorn A, Ng L, McLaughlin KA, Bromet EJ, Stein DJ, Karam EG, Meron Ruscio A, Benjet C, Scott K, Atwoli L, Petukhova M, Lim CCW, Aguilar-Gaxiola S, Al-Hamzawi A, Alonso J, Bunting B, Ciutan M, de Girolamo G, Degenhardt L, Gureje O, Haro JM, Huang Y, Kawakami N, Lee S, Navarro-Mateu F, Pennell BE, Piazza M, Sampson N, Ten Have M, Torres Y, Viana MC, Williams D, Xavier M, Kessler RC. Posttraumatic stress disorder in the World Mental Health Surveys. Psychol Med. 2017 Oct;47(13):2260-2274. doi: 10.1017/S0033291717000708. Epub 2017 Apr 7.'}, {'pmid': '29596582', 'type': 'BACKGROUND', 'citation': 'Baranyi G, Cassidy M, Fazel S, Priebe S, Mundt AP. Prevalence of Posttraumatic Stress Disorder in Prisoners. Epidemiol Rev. 2018 Jun 1;40(1):134-145. doi: 10.1093/epirev/mxx015.'}, {'pmid': '21093904', 'type': 'BACKGROUND', 'citation': 'Fazel S, Baillargeon J. The health of prisoners. Lancet. 2011 Mar 12;377(9769):956-65. doi: 10.1016/S0140-6736(10)61053-7. Epub 2010 Nov 18.'}, {'pmid': '27723815', 'type': 'BACKGROUND', 'citation': 'Ashbaugh AR, Houle-Johnson S, Herbert C, El-Hage W, Brunet A. Psychometric Validation of the English and French Versions of the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5). PLoS One. 2016 Oct 10;11(10):e0161645. doi: 10.1371/journal.pone.0161645. eCollection 2016.'}, {'pmid': '27878323', 'type': 'BACKGROUND', 'citation': 'Jakobowitz S, Bebbington P, McKenzie N, Iveson R, Duffield G, Kerr M, Killaspy H. Assessing needs for psychiatric treatment in prisoners: 2. Met and unmet need. Soc Psychiatry Psychiatr Epidemiol. 2017 Feb;52(2):231-240. doi: 10.1007/s00127-016-1313-5. Epub 2016 Nov 22.'}, {'pmid': '19081454', 'type': 'BACKGROUND', 'citation': 'Vaiva G, Jehel L, Cottencin O, Ducrocq F, Duchet C, Omnes C, Genest P, Rouillon F, Roelandt JL. [Prevalence of trauma-related disorders in the French WHO study: Sante mentale en population generale (SMPG)]. Encephale. 2008 Dec;34(6):577-83. doi: 10.1016/j.encep.2007.11.006. Epub 2008 Apr 2. French.'}]}, 'descriptionModule': {'briefSummary': 'The study will seek to explore the possibility of developing post-traumatic stress disorder following a violent offense commited, among the population of prisoners of the Bordeaux-Gradignan penitentiary center.', 'detailedDescription': 'The overrepresentation of psychiatric disorders among prisoners has been the subject of numerous studies and the significant increase in the number of prisoners over the past 3 decades, make research in prisons a major public health issue.\n\nRecent studies have been able to highlight an over-representation of post-traumatic stress disorder in the prison population. Leading to questionning the factors that could explain the overrepresentation of this disorder in prison with various hypotheses raised. Among these hypotheses, the possibility of developing post-traumatic stress disorder following a violent offense commited has been proposed.\n\nThe study will thus seek to explore the development of a Post-traumatic Stress Disorder following a violent act committed using the PCL-5 questionnaire\n\nStudy design :Observational, descriptive, monocentric study with completion of an anonymous self-questionnaire.\n\nParticipation in the study is voluntary and anonymous with signature of a non-opposition form.\n\nExpected outcomes : better knowledge of this disorder in detention and a hypothesis to explain its overrepresentation. Earlier detection of this pathology in prison could thus be considered, in particular by improving the identification of people at risk according to the presence of contributing factors. More specific support and improved access to care for inmates could be considered, allowing early treatment and thus avoiding progression to other co-morbidities or risk of recidivism.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Prisoners incarcerated in the Bordeaux-Gradignan penitentiary center.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Aged over 18\n* Have as a reason for imprisonment one of the following: Homicide and willful violence resulting in death, Rape or sexual assault, Violence and other personal injury.\n* Having signed and duly completed the Non-Objection form for participation in the study\n* Mastery of the French language'}, 'identificationModule': {'nctId': 'NCT05026450', 'acronym': 'IPTAVC', 'briefTitle': 'Exploring the Psycho-traumatic Impact of a Violent Act Commited at the Bordeaux-Gradignan Penitentiary Center', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Centre Hospitalier Charles Perrens, Bordeaux'}, 'officialTitle': 'Exploring the Psycho-traumatic Impact of a Violent Act Commited - Study Among Inmates of the Bordeaux-Gradignan Penitentiary Center', 'orgStudyIdInfo': {'id': '2021-A01298-33'}}, 'contactsLocationsModule': {'locations': [{'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Centre Hospitalier Charles PERRENS', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}], 'overallOfficials': [{'name': 'Severine BEAUVAIS, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CH CharlesPerrens'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'no IPD sharing plan'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Charles Perrens, Bordeaux', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}