About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Self-questionnaires
Other interventionAll 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.
Cognitive assessment
Other interventionCompletion 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.
Momentary Ecological Assessment (EMA)
Other interventionA 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 emotions deemed intense immediately afterwards that they take place).
Semi-structured interviews ITI and DSCID-II
Other interventionITI 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.
Treatment groups
Trial outcomes
Primary outcomes
Characterizing the emotional pattern
Comparison of DERS scores in groups ( an effect size of 0.37 for the means of DERS by group)
Secondary outcomes
Assessing subjective differences in real-life emotional experience
Frequency of emotional responses observed in a real-life context. The subjective differences in real-life emotional experience between PTSD, PTSD, BPD, cPTSD + BPD and healthy volunteers, without traumatic symptoms, will be apprehended by an ecological momentary assessment protocol (EMA) . For 7 days, subjects will receive 10 daily notifications allowing them to inform their emotional experiences (m-Path application). The topics will complete a series of questions about emotions that have arisen since the last solicitation.
Evaluate physiological responses in hospital consultations and in real life
Physiological parameters of emotion (skin conductance, body temperature and rhythm cardiac) between cPTSD, PTSD, BPD, PTSD+BPD and healthy volunteers, without traumatic symptoms, will be assessed from recording of different physiological parameters of emotion (heart rate, body temperature, skin conductance) made possible by the continuous wearing of a connected watch Empatica (EmbracePlus model, https://www.empatica.com/en-eu/embraceplus/) for 7 days. The physiological recording will be coupled with the subjective momentary ecological assessment.
Studying the cognitive correlates of emotional dysregulation
Cognitive correlates of emotional dysregulation in CPTSD, PTSD, BPD, comorbid presentation of cPTSD + BPD and in healthy volunteers without traumatic symptoms will be assessed on the basis of several specific cognitive tests proposed during the visit of follow-up n°1 (V1).
Investigate the concordance between subjective and physiological measures of dysregulation Emotional
The concordance between subjective, physiological and cognitive measures of dysregulation emotional studies collected in a real-life context (between V1 and V2) in patients (i.e. cPTSD, PTSD, BPD, cPTSD + BPD) and healthy volunteers, will be assessed from the correlation coefficients between frequency, intensity and emotional variability, conductance parameters body temperature and heart rate and response times and number of error to the emotional Stroop
Locations
Sponsors and contacts
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