NCT Number: NCT06848127
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
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
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.
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.
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 emotions deemed intense immediately afterwards that they take place).
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.
Time frame: Day 1
Comparison of DERS scores in groups ( an effect size of 0.37 for the means of DERS by group)
Time frame: From Day 14 till Day 21
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.
Time frame: From Day 7 to Day 14
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.
Time frame: From Day 7 to Day 14
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).
Time frame: Up to 3 years
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
Time frame: Up to 3 years
Coefficients of correlations between cognitive performance and physiological parameters. The concordance between cognitive and physiological measures, obtained in consultation, in patients (i.e. cPTSD, PTSD, BPD, cPTSD + BPD) and healthy volunteers, will be assessed from analyses correlations between performance (response times and errors) on each cognitive test and various physiological parameters recorded by the Biopac (carried out during a V1 visit).
Time frame: Up to 3 years
Coefficients of correlations between self-questionnaire scores and performance Cognitive. The combination of subjective (self-questionnaires) and cognitive measures of dysregulation in patients (i.e. cPTSD, PTSD, BPD, cPTSD+BPD) and healthy volunteers, will be assessed on the basis of the correlation coefficients between the scores on the DERS, BEDS, PAQ and FREE and performance (response times and errors) at each cognitive test (fluences verbal, emotional hayling, negative priming task, memory recovery task associative-dissociative and heart rhythm detection task) carried out in visit V1).
Time frame: Up to 3 years
Scores obtained by subjects on supplementary questionnaires (i.e. not on emotional experience). The symptomatic characteristics of the different groups of subjects will be evaluated from their scores on the additional self questionnaires, proposed during the inclusion visit.
Time frame: Up to 3 years
Pre/Post Therapy Comparison of Dysregulation Self-Questionnaire Scores Emotional Following psychotherapy in routine care, it is expected that self-questionnaire scores on emotional dysregulation, namely DERS have significantly decreased in patients with cPTSD, PTSD, BPD, or cPTSD+BPD and significantly increased on the FREE scale. The investigators postulate that post-therapy scores of patients will be comparable to the scores of healthy subjects.
Time frame: Up to 3 years
Pre/Post Therapy Comparison of Frequency of Experiences emotional problems recorded in a real-life protocol (momentary ecological assessment, EMA).
Time frame: Up to 3 years
Pre/Post Therapy Comparison of the Physiological Parameters of Emotion Recorded by the Empatica EmbracePlus smartwatch.
Time frame: From Day 14 till Day 21
Intensity and variability 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.
Time frame: From Day 14 till Day 21
Variability 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.
Time frame: From Day 7 to Day 14
Physiological differences in emotional experiences between cPTSD, PTSD, BPD, PTSD+BPD and healthy volunteers, without traumatic symptoms, will be assessed from recording of the physiological parameters of the emotion will be made during the V1 visit to the University Hospitals of Strasbourg, in parallel with the taking of the tests via the Biopac wireless measurement system.
Time frame: Up to 3 years
Pre/Post Therapy Comparison of Dysregulation Self-Questionnaire Scores Emotional Following psychotherapy in routine care, it is expected that self-questionnaire scores on emotional dysregulation, namely BEDS have significantly decreased in patients with cPTSD, PTSD, BPD, or cPTSD+BPD and significantly increased on the FREE scale. The investigators postulate that post-therapy scores of patients will be comparable to the scores of healthy subjects.
Time frame: Up to 3 years
Pre/Post Therapy Comparison of Dysregulation Self-Questionnaire Scores Emotional Following psychotherapy in routine care, it is expected that self-questionnaire scores on emotional dysregulation, namely PAQ have significantly decreased in patients with cPTSD, PTSD, BPD, or cPTSD+BPD and significantly increased on the FREE scale. The investigators postulate that post-therapy scores of patients will be comparable to the scores of healthy subjects.
Time frame: Up to 3 years
Pre/Post Therapy Comparison of Intensity of Experiences emotional problems recorded in a real-life protocol (momentary ecological assessment, EMA).
Time frame: Up to 3 years
Pre/Post Therapy Comparison of Variability of Experiences emotional problems recorded in a real-life protocol (momentary ecological assessment, EMA).
Time frame: Up to 3 years
Pre/Post Therapy Comparison of Performance in Verbal Fluency Tests emotional and autobiographical, to the emotional Hayling.
Time frame: Up to 3 years
Pre/Post Therapy Comparison of Performance in Verbal Fluency Tests emotional and autobiographical, to a negative priming task.
Time frame: Up to 3 years
Pre/Post Therapy Comparison of Performance in Verbal Fluency Tests emotional and autobiographical to the Heart Rhythm Detection Task.
Time frame: Up to 3 years
Pre/Post Therapy Comparison of Performance in Verbal Fluency Tests emotional and autobiographical to an Emotional Stroop.
Contact information is provided by the study sponsor or research team.
University Hospital, Strasbourg, France
Other
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
Acronym: TR-EMA
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