Complex Post-Traumatic Stress Disorder (CPTSD)TR-EMANCT06848127
Study of Emotional Dysregulation in Complex Post-Traumatic Stress Disorder
A study testing Self-questionnaires, Cognitive assessment and Momentary Ecological Assessment (EMA) in people with Complex Post-Traumatic Stress Disorder (CPTSD) and Borderline Personality Disorder (BPD), run by University Hospital, Strasbourg, France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Complex Post-Traumatic Stress Disorder (CPTSD), Borderline Personality Disorder (BPD), Post-traumatic Stress Disorder (PTSD)
- What is being tested?
- Self-questionnaires, Cognitive assessment and Momentary Ecological Assessment (EMA)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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
- Conditions
- Complex Post-Traumatic Stress Disorder (CPTSD), Borderline Personality Disorder (BPD), Post-traumatic Stress Disorder (PTSD)
- Being tested
- Self-questionnaires, Cognitive assessment, Momentary Ecological Assessment (EMA), Semi-structured interviews ITI and DSCID-II
- Medical subject headings
- Borderline Personality Disorder, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-questionnairesOther
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 assessmentOther
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)Other
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-IIOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy voluntary group | Active comparator | 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. Receives: Other: Self-questionnaires; Other: Cognitive assessment; Other: Momentary Ecological Assessment (EMA) |
| Group Patients with cPTSD | Experimental | 30 Patients diagnosed with cPTSD according to ICD-11 criteria Receives: Other: Self-questionnaires; Other: Cognitive assessment; Other: Momentary Ecological Assessment (EMA); Other: Semi-structured interviews ITI and DSCID-II |
| Group Patients with PTSD | Experimental | 30 Patients diagnosed with PTSD according to ICD-11 criteria Receives: Other: Self-questionnaires; Other: Cognitive assessment; Other: Momentary Ecological Assessment (EMA); Other: Semi-structured interviews ITI and DSCID-II |
| Group Patients with BPD | Experimental | 30 Patients with a diagnosis of BPD, according to DSM-5 criteria Receives: Other: Self-questionnaires; Other: Cognitive assessment; Other: Momentary Ecological Assessment (EMA); Other: Semi-structured interviews ITI and DSCID-II |
| Group Patients with cPTSD + BPD comorbidity | Experimental | 30 Patients with cPTSD + BPD comorbidity, established prior to inclusion Receives: Other: Self-questionnaires; Other: Cognitive assessment; Other: Momentary Ecological Assessment (EMA); Other: Semi-structured interviews ITI and DSCID-II |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterizing the emotional pattern
Comparison of DERS scores in groups ( an effect size of 0.37 for the means of DERS by group)
Measured: Day 1
Secondary outcomes (21)
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.
Measured: From Day 14 till Day 21
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.
Measured: From Day 7 to Day 14
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).
Measured: From Day 7 to Day 14
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
Measured: Up to 3 years
The concordance between cognitive and physiological measures of dysregulation Emotional
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).
Measured: Up to 3 years
The association between subjective and cognitive measures of emotional dysregulation
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).
Measured: Up to 3 years
Understand the entire clinical picture of cPTSD
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.
Measured: Up to 3 years
The evolution of self-reported emotional dysregulation after psychotherapeutic treatment in routine care
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.
Measured: Up to 3 years
The evolution of emotional dynamics, assessed in daily life, after treatment psychotherapy in routine care
Pre/Post Therapy Comparison of Frequency of Experiences emotional problems recorded in a real-life protocol (momentary ecological assessment, EMA).
Measured: Up to 3 years
The evolution of physiological emotional responses, assessed in daily life and in consultation, after psychotherapeutic treatment in routine care
Pre/Post Therapy Comparison of the Physiological Parameters of Emotion Recorded by the Empatica EmbracePlus smartwatch.
Measured: Up to 3 years
Assessing subjective differences in real-life emotional experience
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.
Measured: From Day 14 till Day 21
Assessing subjective differences in real-life emotional experience
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.
Measured: From Day 14 till Day 21
Evaluate emotional responses in hospital consultations and in real life
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.
Measured: From Day 7 to Day 14
The evolution of self-reported emotional dysregulation after psychotherapeutic treatment in routine care
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.
Measured: Up to 3 years
The evolution of self-reported emotional dysregulation after psychotherapeutic treatment in routine care
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.
Measured: Up to 3 years
The evolution of emotional dynamics, assessed in daily life, after treatment psychotherapy in routine care
Pre/Post Therapy Comparison of Intensity of Experiences emotional problems recorded in a real-life protocol (momentary ecological assessment, EMA).
Measured: Up to 3 years
The evolution of emotional dynamics, assessed in daily life, after treatment psychotherapy in routine care
Pre/Post Therapy Comparison of Variability of Experiences emotional problems recorded in a real-life protocol (momentary ecological assessment, EMA).
Measured: Up to 3 years
The evolution of cognitive functioning underlying emotional dysregulation, after Psychotherapeutic treatment in routine care
Pre/Post Therapy Comparison of Performance in Verbal Fluency Tests emotional and autobiographical, to the emotional Hayling.
Measured: Up to 3 years
The evolution of cognitive functioning underlying emotional dysregulation, after Psychotherapeutic treatment in routine care
Pre/Post Therapy Comparison of Performance in Verbal Fluency Tests emotional and autobiographical, to a negative priming task.
Measured: Up to 3 years
The evolution of cognitive functioning underlying emotional dysregulation, after Psychotherapeutic treatment in routine care
Pre/Post Therapy Comparison of Performance in Verbal Fluency Tests emotional and autobiographical to the Heart Rhythm Detection Task.
Measured: Up to 3 years
The evolution of cognitive functioning underlying emotional dysregulation, after Psychotherapeutic treatment in routine care
Pre/Post Therapy Comparison of Performance in Verbal Fluency Tests emotional and autobiographical to an Emotional Stroop.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Post-Traumatic Stress Disorder (CPTSD)Studies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luisa WEINER, Professor, Principal investigator, Department of Psychiatry II Psychiatry, Mental Health and Addiction Medicine, University Hospitals of Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06848127
- Sponsor's protocol ID
- 9362
- Other IDs
- 2024-A01240-47
- Acronym
- TR-EMA
- Status last verified
- Feb 2025
- First submitted
- 12 Feb 2025
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06848127
- Acronym / sponsor ID
- TR-EMA / 9362
- Conditions
- Complex Post-Traumatic Stress Disorder (CPTSD), Borderline Personality Disorder (BPD), Post-traumatic Stress Disorder (PTSD)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 26 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Healthy voluntary group | Active comparator | Other: Self-questionnaires, Other: Cognitive assessment, Other: Momentary Ecological Assessment (EMA)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. |
| Group Patients with cPTSD | Experimental | Other: Self-questionnaires, Other: Cognitive assessment, Other: Momentary Ecological Assessment (EMA), Other: Semi-structured interviews ITI and DSCID-II30 Patients diagnosed with cPTSD according to ICD-11 criteria |
| Group Patients with PTSD | Experimental | Other: Self-questionnaires, Other: Cognitive assessment, Other: Momentary Ecological Assessment (EMA), Other: Semi-structured interviews ITI and DSCID-II30 Patients diagnosed with PTSD according to ICD-11 criteria |
| Group Patients with BPD | Experimental | Other: Self-questionnaires, Other: Cognitive assessment, Other: Momentary Ecological Assessment (EMA), Other: Semi-structured interviews ITI and DSCID-II30 Patients with a diagnosis of BPD, according to DSM-5 criteria |
| Group Patients with cPTSD + BPD comorbidity | Experimental | Other: Self-questionnaires, Other: Cognitive assessment, Other: Momentary Ecological Assessment (EMA), Other: Semi-structured interviews ITI and DSCID-II30 Patients with cPTSD + BPD comorbidity, established prior to inclusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-questionnairesAll 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. | Other | Group Patients with BPD, Group Patients with PTSD, Group Patients with cPTSD, Group Patients with cPTSD + BPD comorbidity, Healthy voluntary group |
| Cognitive assessmentCompletion 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. | Other | Group Patients with BPD, Group Patients with PTSD, Group Patients with cPTSD, Group Patients with cPTSD + BPD comorbidity, Healthy voluntary group |
| 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). | Other | Group Patients with BPD, Group Patients with PTSD, Group Patients with cPTSD, Group Patients with cPTSD + BPD comorbidity, Healthy voluntary group |
| Semi-structured interviews ITI and DSCID-IIITI 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. | Other | Group Patients with BPD, Group Patients with PTSD, Group Patients with cPTSD, Group Patients with cPTSD + BPD comorbidity |
Primary outcome
Characterizing the emotional pattern
Time frame: Day 1
Comparison of DERS scores in groups ( an effect size of 0.37 for the means of DERS by group)
21 secondary outcomes
Assessing subjective differences in real-life emotional experience
Time frame: From Day 14 till Day 21
Evaluate physiological responses in hospital consultations and in real life
Time frame: From Day 7 to Day 14
Studying the cognitive correlates of emotional dysregulation
Time frame: From Day 7 to Day 14
Investigate the concordance between subjective and physiological measures of dysregulation Emotional
Time frame: Up to 3 years
The concordance between cognitive and physiological measures of dysregulation Emotional
Time frame: Up to 3 years
The association between subjective and cognitive measures of emotional dysregulation
Time frame: Up to 3 years
Understand the entire clinical picture of cPTSD
Time frame: Up to 3 years
The evolution of self-reported emotional dysregulation after psychotherapeutic treatment in routine care
Time frame: Up to 3 years
The evolution of emotional dynamics, assessed in daily life, after treatment psychotherapy in routine care
Time frame: Up to 3 years
The evolution of physiological emotional responses, assessed in daily life and in consultation, after psychotherapeutic treatment in routine care
Time frame: Up to 3 years
Assessing subjective differences in real-life emotional experience
Time frame: From Day 14 till Day 21
Assessing subjective differences in real-life emotional experience
Time frame: From Day 14 till Day 21
Evaluate emotional responses in hospital consultations and in real life
Time frame: From Day 7 to Day 14
The evolution of self-reported emotional dysregulation after psychotherapeutic treatment in routine care
Time frame: Up to 3 years
The evolution of self-reported emotional dysregulation after psychotherapeutic treatment in routine care
Time frame: Up to 3 years
The evolution of emotional dynamics, assessed in daily life, after treatment psychotherapy in routine care
Time frame: Up to 3 years
The evolution of emotional dynamics, assessed in daily life, after treatment psychotherapy in routine care
Time frame: Up to 3 years
The evolution of cognitive functioning underlying emotional dysregulation, after Psychotherapeutic treatment in routine care
Time frame: Up to 3 years
The evolution of cognitive functioning underlying emotional dysregulation, after Psychotherapeutic treatment in routine care
Time frame: Up to 3 years
The evolution of cognitive functioning underlying emotional dysregulation, after Psychotherapeutic treatment in routine care
Time frame: Up to 3 years
The evolution of cognitive functioning underlying emotional dysregulation, after Psychotherapeutic treatment in routine care
Time frame: Up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Luisa WEINER, Professor principal investigator
Department of Psychiatry II Psychiatry, Mental Health and Addiction Medicine, University Hospitals of Strasbourg
Questions about this trial
What is this clinical trial studying?
A study testing Self-questionnaires, Cognitive assessment and Momentary Ecological Assessment (EMA) in people with Complex Post-Traumatic Stress Disorder (CPTSD) and Borderline Personality Disorder (BPD), run by University Hospital, Strasbourg, France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luisa WEINER, Professor (0033388116511, luisa.weiner@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterizing the emotional pattern (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2025.