[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100581270":3},{"organization":4,"armGroups":7,"interventions":34,"overallOfficials":52,"centralContacts":57,"locations":39,"responsibleParty":62,"collaborators":39,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":72,"sex":73,"minAge":74,"maxAge":39,"enrollmentInfo":75,"targetDuration":39,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":39,"overallStatus":86,"whyStopped":39,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":39},{"fullName":5,"class":6},"University Hospital, Strasbourg, France","OTHER",[8,16,22,26,30],{"label":9,"type":10,"description":11,"interventionNames":12},"Healthy voluntary group","ACTIVE_COMPARATOR","50 healthy volunteers who have been exposed to a traumatic event but without traumatic symptoms and with subthreshold scores on the PTSD Checklist for DSM-5 and Borderline Symptom List.",[13,14,15],"Other: Self-questionnaires","Other: Cognitive assessment","Other: Momentary Ecological Assessment (EMA)",{"label":17,"type":18,"description":19,"interventionNames":20},"Group Patients with cPTSD","EXPERIMENTAL","30 Patients diagnosed with cPTSD according to ICD-11 criteria",[13,14,15,21],"Other: Semi-structured interviews ITI and DSCID-II",{"label":23,"type":18,"description":24,"interventionNames":25},"Group Patients with PTSD","30 Patients diagnosed with PTSD according to ICD-11 criteria",[13,14,15,21],{"label":27,"type":18,"description":28,"interventionNames":29},"Group Patients with BPD","30 Patients with a diagnosis of BPD, according to DSM-5 criteria",[13,14,15,21],{"label":31,"type":18,"description":32,"interventionNames":33},"Group Patients with cPTSD + BPD comorbidity","30 Patients with cPTSD + BPD comorbidity, established prior to inclusion",[13,14,15,21],[35,40,44,48],{"type":6,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"Self-questionnaires","All subjects (healthy volunteers and all patients) will complete a battery of self-questionnaires, assessing emotional dysregulation, traumatic symptoms, alteration of the sense of self, sensitivity to social rejection, dissociative symptoms, child abuse, functional repercussions of the disorders, depressive and anxiety symptoms and Impulsivity.",[27,23,17,31,9],null,{"type":6,"name":41,"description":42,"armGroupLabels":43,"otherNames":39},"Cognitive assessment","Completion of cognitive assessment, consisting of verbal fluency tasks , emotional Hayling, a dissociative associative memory retrieval task, a negative priming task and a heart rhythm detection task. The tasks of associative-dissociative memory retrieval, negative priming and heart rhythm detection will be coupled with a physiological recording, via a Biopac, to measure the change in skin conductance, body temperature and heart rate. The negative priming task will also be associated with the recording of eye movements allowing an indirect measurement of attentional orientation.",[27,23,17,31,9],{"type":6,"name":45,"description":46,"armGroupLabels":47,"otherNames":39},"Momentary Ecological Assessment (EMA)","A momentary ecological evaluation protocol will be proposed (between visits V1 and V2 for all subjects and between V3 and V4 for the 4 groups of patients) in order to assess emotional and symptomatic dynamics in a daily life context through a connected wath. During 7 days, subjects will be invited, via their smartphone, to carry out daily semi-random readings (indicated by smartphone notifications) of their subjective emotional experiences (10 once\u002Fday), but also spontaneous (by reporting emotions deemed intense immediately afterwards that they take place).",[27,23,17,31,9],{"type":6,"name":49,"description":50,"armGroupLabels":51,"otherNames":39},"Semi-structured interviews ITI and DSCID-II","ITI International Trauma Interview is a semi-structured interview consisting of one part allocated to the description of a traumatic event and two parts addressing the symptoms of PTSD (i.e. reliving, avoidance and alteration of wakefulness) and the symptoms of the disturbance of self-organization.\n\nThe SCID-II Structured Clinical Interview for DSM-IV Personality Disorder is a 90-item semi-structured interview, covering all 10 categories of personality disorder as described in the DSM-IV.",[27,23,17,31],[53],{"name":54,"affiliation":55,"role":56},"Luisa WEINER, Professor","Department of Psychiatry II Psychiatry, Mental Health and Addiction Medicine, University Hospitals of Strasbourg","PRINCIPAL_INVESTIGATOR",[58],{"name":54,"role":59,"phone":60,"phoneExt":39,"email":61},"CONTACT","0033388116511","luisa.weiner@chru-strasbourg.fr",{"type":63,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR","100581270","study-of-emotional-dysregulation-in-complex-post-traumatic-stress-disorder-100581270",false,"NCT06848127","Study of Emotional Dysregulation in Complex Post-Traumatic Stress Disorder","At the Frontier of Post-Traumatic Stress Disorder and Borderline Personality Disorder: Characterization Complex Post-traumatic Stress Disorder Via an Ecological, Physiological and Cognitive Approach to the Emotional Dysregulation","TR-EMA","Inclusion Criteria:\n\n* Inclusion criteria common to healthy patients and volunteers: Subject, male or female, over 18 years of age; Subject able to understand the objectives and risks of the research and to give informed, dated and signed consent; Subject affiliated to a social protection health insurance scheme, beneficiary or beneficiary.\n* Patient-specific inclusion criteria: Patient with a diagnosis of PTSD or PTSD according to ICD-11 criteria (World Health Organization, 2018). OR Patient with a diagnosis of BPD, according to DSM-5 criteria (American Psychiatric Association, 2013). OR Patient with cPTSD + BPD comorbidity, established prior to inclusion.\n* Inclusion criteria specific to healthy volunteers: Subject who has been exposed to a traumatic event (Life Events Checklist, Gray et al., 2004) but without traumatic symptoms, or has subcut-off scores on PTSD scales (PCL-5, PTSD Checklist for DSM-5, Blevins et al., 2015), and TPB (BSL-23, Borderline Symptom List, Nicastro et al., 2016).\n\nExclusion Criteria:\n\n* Non-inclusion criteria common to healthy patients and volunteers:\n\nSubject who does not have a smartphone with an internet connection; Subject in an exclusion period (determined by a previous or ongoing study); Participation in another clinical study that may interfere with the study; Inability to provide the subject with informed information (subject in an emergency or life-threatening situation); Subject under the protection of justice; Subject under guardianship or curatorship; Pregnancy and\u002For breastfeeding.\n\n-Patient-specific non-inclusion criteria: Patient with a diagnosis of a psychotic disorder (according to DSM-5 criteria, American Psychiatric Association, 2013); Patient with a diagnosis of severe substance use disorder (according to DSM-5 criteria, American Psychiatric Association, 2013); Patient with an intellectual disability (IQ ≤ 70); Patient with neurological (acquired brain injury) or neurovegetative comorbidity; Patient following or having undergone psychotherapy of the Dialectical Behavior Therapy (DBT) type; Patient with severe cardiac disorders; Patient on therapy that alters physiological response (e.g., beta-blockers).\n\n-Specific non-inclusion criteria for healthy volunteers: Subject with a history of psychiatric, neurodevelopmental, neurological, neurovegetative or cardiac disorders; Subject on psychotropic therapy or treatment modifying physiological parameters (e.g., beta-blockers).",true,"ALL","18 Years",{"count":76,"type":77},170,"ESTIMATED","INTERVENTIONAL",[80],"NA","This study aims to characterize emotional dysregulation in complex post-traumatic stress disorder (cPTSD) and to determine the extent to which it can promote the distinction with borderline personality disorder (BPD) and post-traumatic stress disorder (PTSD).\n\nAs emotional dysregulation is a dynamic process whose phenomenological manifestations are labile, associated with physiological modifications and modulated by cognitive processing, a multiple methodology associating measurements in a real-life ecological context with measurements performed in the hospital will be preferred.\n\nOverall, this study proposes to capture, for the first time, the clinical manifestations associated with cPTSD from the perspective of emotional dysregulation and its underlying processes",[83,84,85],"Complex Post-Traumatic Stress Disorder (CPTSD)","Borderline Personality Disorder (BPD)","Post-traumatic Stress Disorder (PTSD)","NOT_YET_RECRUITING","2025-02-20",{"date":89,"type":90},"2025-02-26","ACTUAL",{"date":92,"type":77},"2025-03-01",{"date":94,"type":77},"2027-12-01",{"name":5,"class":6}]