Study of Emotional Dysregulation in Complex Post-Traumatic Stress Disorder

Официальное название

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

Обзор

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). As 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. Overall, 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

Вмешательства

• Другое 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.
• Другое 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 re
• Другое 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/day), but also spontaneous (by reporting emotio
• Другое 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. The 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.

Первичные конечные точки

• Characterizing the emotional pattern [Срок оценки: Day 1]

Вторичные конечные точки (12)

• Assessing subjective differences in real-life emotional experience [Срок оценки: From Day 14 till Day 21]
• Evaluate physiological responses in hospital consultations and in real life [Срок оценки: From Day 7 to Day 14]
• Studying the cognitive correlates of emotional dysregulation [Срок оценки: From Day 7 to Day 14]
• Investigate the concordance between subjective and physiological measures of dysregulation Emotional [Срок оценки: Up to 3 years]
• The concordance between cognitive and physiological measures of dysregulation Emotional [Срок оценки: Up to 3 years]
• The association between subjective and cognitive measures of emotional dysregulation [Срок оценки: Up to 3 years]
• Understand the entire clinical picture of cPTSD [Срок оценки: Up to 3 years]
• The evolution of self-reported emotional dysregulation after psychotherapeutic treatment in routine care [Срок оценки: Up to 3 years]
• The evolution of emotional dynamics, assessed in daily life, after treatment psychotherapy in routine care [Срок оценки: Up to 3 years]
• The evolution of physiological emotional responses, assessed in daily life and in consultation, after psychotherapeutic treatment in routine care [Срок оценки: Up to 3 years]
• Assessing subjective differences in real-life emotional experience [Срок оценки: From Day 14 till Day 21]
• Assessing subjective differences in real-life emotional experience [Срок оценки: From Day 14 till Day 21]

Критерии участия

Критерии включения

• 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.
• 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.
• 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).

Критерии исключения

• Non-inclusion criteria common to healthy patients and volunteers:

Subject 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/or breastfeeding.

-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).

-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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06848127 · 9362 · 2024-A01240-47

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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