Study of Emotional Dysregulation in Complex Post-Traumatic Stress Disorder
NCT ID: NCT06848127
Last Updated: 2025-02-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
170 participants
INTERVENTIONAL
2025-03-01
2027-12-01
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Healthy voluntary group
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.
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.
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.
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 emotions deemed intense immediately afterwards that they take place).
Group Patients with cPTSD
30 Patients diagnosed with cPTSD according to ICD-11 criteria
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.
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.
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 emotions deemed intense immediately afterwards that they take place).
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.
Group Patients with PTSD
30 Patients diagnosed with PTSD according to ICD-11 criteria
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.
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.
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 emotions deemed intense immediately afterwards that they take place).
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.
Group Patients with BPD
30 Patients with a diagnosis of BPD, according to DSM-5 criteria
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.
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.
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 emotions deemed intense immediately afterwards that they take place).
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.
Group Patients with cPTSD + BPD comorbidity
30 Patients with cPTSD + BPD comorbidity, established prior to inclusion
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.
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.
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 emotions deemed intense immediately afterwards that they take place).
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.
Interventions
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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.
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.
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 emotions deemed intense immediately afterwards that they take place).
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.
Eligibility Criteria
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Inclusion Criteria
18 Years
ALL
Yes
Sponsors
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University Hospital, Strasbourg, France
OTHER
Responsible Party
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Principal Investigators
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Luisa WEINER, Professor
Role: PRINCIPAL_INVESTIGATOR
Department of Psychiatry II Psychiatry, Mental Health and Addiction Medicine, University Hospitals of Strasbourg
Central Contacts
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Other Identifiers
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2024-A01240-47
Identifier Type: OTHER
Identifier Source: secondary_id
9362
Identifier Type: -
Identifier Source: org_study_id
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