Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2026-02-28 @ 5:28 AM
Study NCT ID:
NCT03770156
Status:
COMPLETED
Last Update Posted:
2025-09-15
First Post:
2018-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Terrorist Attack - Continuity of Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-08', 'studyFirstSubmitDate': '2018-12-06', 'studyFirstSubmitQcDate': '2018-12-07', 'lastUpdatePostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Global Impression - Improvement scale (CGI-I)', 'timeFrame': 'One day', 'description': 'Self-assessment of improvement or aggravation'}], 'secondaryOutcomes': [{'measure': 'Clinical Global Impression - Severity scale (CGI-S)', 'timeFrame': 'One day', 'description': 'Self-assessment of symptom severity'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Terrorist attack', 'Post-Traumatic Stress Disorder', 'Depression', 'Psychotherapy', 'Mental health', 'Victimology', 'Mourning'], 'conditions': ['Post-Traumatic Stress Disorder', 'Major Depressive Episode']}, 'descriptionModule': {'briefSummary': 'On November 13th 2015, a terrorist attack killed 129 victims in Paris. An emergency crisis unit (CUMP) has been activated in Paris in the days following the attack and a subunit was in charge to answer to the phone calls of victims and their relatives. The same emergency crisis unit have been activated for the terrorist attack in London, 2017 june 3, terrorist attack in Barcelone 2017 august 17-18, terrorist attack in Strasbourg 2018 December 11 The purpose of this observational study is to document the evolution of psychiatric symptoms among subjects who called the CUMP and to collect information about the type of medical or non-medical care they were seeking for.', 'detailedDescription': 'The care of the victims of natural disasters or mass disasters such as terrorist attacks is now better structured and organized. The efficacy of debriefing or of defusing has been and is still debated, sometimes bitterly. The aim of the present study is not to demonstrate utility or futility of such approaches, but to i) evaluate their global improvement over the past three years. ii) to list the type of support that the victims were seeking in their attempt to get rid of the symptoms which appeared after the terrorist attack of November 2015 in Paris.\n\niii) to collect their opinions about the way the CUMP (emergency medico-psychological unit of Paris, France) managed the support to the victims.\n\nParticipating subjects registered on the occasion of their first contact with the CUMP 75 by phone during the week following the attack'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects who called the CUMP of Paris, London, Barcelone and Strasbourg after terrorist attacks were either direct, undirect victims or their relatives.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- All subjects who called the CUMP of Paris between November 13th, 2015 and January 31st, 2016; London 11th,2017 ; Barcelone 17-18th, 2017 ; Strasbourg 11th, 2018 and completed the questionnaire.\n\nExclusion Criteria:\n\n\\- Subjects who did not consent to their participation to the study.'}, 'identificationModule': {'nctId': 'NCT03770156', 'acronym': 'CUMP75', 'briefTitle': 'Terrorist Attack - Continuity of Care', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Attentats - Continuité Des Soins', 'orgStudyIdInfo': {'id': 'NI18012J'}, 'secondaryIdInfos': [{'id': '2017-A01382-51', 'type': 'OTHER', 'domain': 'ID-RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Subjects who contacted CUMP by phone', 'description': 'Subjects who contacted CUMP (Medical Psychological Emergency Cell) by phone from Paris November 13th, 2015, London 11th,2017 ; Barcelone 17-18th, 2017 ; Strasbourg 11th, 2018.', 'interventionNames': ['Behavioral: Questionnaires']}], 'interventions': [{'name': 'Questionnaires', 'type': 'BEHAVIORAL', 'description': 'Overall Impression of the current state and evolution since the attacks', 'armGroupLabels': ['Subjects who contacted CUMP by phone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'CUMP Paris', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Gaëlle ABGRALL-BARBRY, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}, {'name': 'Gaëlle ABGRALL-BARBRY, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'URC-CIC Paris Descartes Necker Cochin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}