Clinical trial NCT06848127: Study of Emotional Dysregulation in Complex Post-Traumatic Stress Disorder
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Complex Post-Traumatic Stress Disorder (CPTSD)
Borderline Personality Disorder (BPD)
Post-traumatic Stress Disorder (PTSD)
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2025-02-26
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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


Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Characterizing the emotional pattern
timeFrame: Day 1
Secondary outcomes:
measure: Assessing subjective differences in real-life emotional experience
timeFrame: From Day 14 till Day 21
measure: Evaluate physiological responses in hospital consultations and in real life
timeFrame: From Day 7 to Day 14
measure: Studying the cognitive correlates of emotional dysregulation
timeFrame: From Day 7 to Day 14
measure: Investigate the concordance between subjective and physiological measures of dysregulation Emotional
timeFrame: Up to 3 years
measure: The concordance between cognitive and physiological measures of dysregulation Emotional
timeFrame: Up to 3 years
measure: The association between subjective and cognitive measures of emotional dysregulation
timeFrame: Up to 3 years
measure: Understand the entire clinical picture of cPTSD
timeFrame: Up to 3 years
measure: The evolution of self-reported emotional dysregulation after psychotherapeutic treatment in routine care
timeFrame: Up to 3 years
measure: The evolution of emotional dynamics, assessed in daily life, after treatment psychotherapy in routine care
timeFrame: Up to 3 years
measure: The evolution of physiological emotional responses, assessed in daily life and in consultation, after psychotherapeutic treatment in routine care
timeFrame: Up to 3 years
measure: Assessing subjective differences in real-life emotional experience
timeFrame: From Day 14 till Day 21
measure: Assessing subjective differences in real-life emotional experience
timeFrame: From Day 14 till Day 21
measure: Evaluate emotional responses in hospital consultations and in real life
timeFrame: From Day 7 to Day 14
measure: The evolution of self-reported emotional dysregulation after psychotherapeutic treatment in routine care
timeFrame: Up to 3 years
measure: The evolution of self-reported emotional dysregulation after psychotherapeutic treatment in routine care
timeFrame: Up to 3 years
measure: The evolution of emotional dynamics, assessed in daily life, after treatment psychotherapy in routine care
timeFrame: Up to 3 years
measure: The evolution of emotional dynamics, assessed in daily life, after treatment psychotherapy in routine care
timeFrame: Up to 3 years
measure: The evolution of cognitive functioning underlying emotional dysregulation, after Psychotherapeutic treatment in routine care
timeFrame: Up to 3 years
measure: The evolution of cognitive functioning underlying emotional dysregulation, after Psychotherapeutic treatment in routine care
timeFrame: Up to 3 years
measure: The evolution of cognitive functioning underlying emotional dysregulation, after Psychotherapeutic treatment in routine care
timeFrame: Up to 3 years
measure: The evolution of cognitive functioning underlying emotional dysregulation, after Psychotherapeutic treatment in routine care
timeFrame: Up to 3 years
Other outcomes:
Locations:
Study officials:
affiliation: Department of Psychiatry II Psychiatry, Mental Health and Addiction Medicine, University Hospitals of Strasbourg
name: Luisa WEINER, Professor
role: PRINCIPAL_INVESTIGATOR
References: