Study of Emotional Dysregulation in Complex Post-Traumatic Stress Disorder
TR-EMA
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
2 other identifiers
interventional
170
0 countries
N/A
Brief Summary
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2025
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 12, 2025
CompletedFirst Posted
Study publicly available on registry
February 26, 2025
CompletedStudy Start
First participant enrolled
March 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
February 26, 2025
February 1, 2025
2 years
February 12, 2025
February 20, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Characterizing the emotional pattern
Comparison of DERS scores in groups ( an effect size of 0.37 for the means of DERS by group)
Day 1
Secondary Outcomes (21)
Assessing subjective differences in real-life emotional experience
From Day 14 till Day 21
Evaluate physiological responses in hospital consultations and in real life
From Day 7 to Day 14
Studying the cognitive correlates of emotional dysregulation
From Day 7 to Day 14
Investigate the concordance between subjective and physiological measures of dysregulation Emotional
Up to 3 years
The concordance between cognitive and physiological measures of dysregulation Emotional
Up to 3 years
- +16 more secondary outcomes
Study Arms (5)
Healthy voluntary group
ACTIVE COMPARATOR50 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.
Group Patients with cPTSD
EXPERIMENTAL30 Patients diagnosed with cPTSD according to ICD-11 criteria
Group Patients with PTSD
EXPERIMENTAL30 Patients diagnosed with PTSD according to ICD-11 criteria
Group Patients with BPD
EXPERIMENTAL30 Patients with a diagnosis of BPD, according to DSM-5 criteria
Group Patients with cPTSD + BPD comorbidity
EXPERIMENTAL30 Patients with cPTSD + BPD comorbidity, established prior to inclusion
Interventions
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.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Luisa WEINER, Professor
Department of Psychiatry II Psychiatry, Mental Health and Addiction Medicine, University Hospitals of Strasbourg
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 12, 2025
First Posted
February 26, 2025
Study Start
March 1, 2025
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
February 26, 2025
Record last verified: 2025-02