Study of Emotional Dysregulation in Complex Post-Traumatic Stress Disorder (TR-EMA)

University Hospital, Strasbourg, France

Status: Not yet enrolling

Conditions: Post-traumatic Stress Disorder (PTSD); Complex Post-Traumatic Stress Disorder (CPTSD); Borderline Personality Disorder (BPD)

Treatments: Other: Momentary Ecological Assessment (EMA); Other: Cognitive assessment; Other: Semi-structured interviews ITI and DSCID-II; Other: Self-questionnaires

Study type: Interventional

Funder types: Other

Identifiers

NCT06848127

9362

2024-A01240-47 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 170 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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170 participants in 5 patient groups

Healthy voluntary group

Active Comparator group

Description:

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.

Treatment:

Other: Self-questionnaires

Other: Cognitive assessment

Other: Momentary Ecological Assessment (EMA)

Group Patients with cPTSD

Experimental group

Description:

30 Patients diagnosed with cPTSD according to ICD-11 criteria

Treatment:

Other: Self-questionnaires

Other: Semi-structured interviews ITI and DSCID-II

Other: Cognitive assessment

Other: Momentary Ecological Assessment (EMA)

Group Patients with PTSD

Experimental group

Description:

30 Patients diagnosed with PTSD according to ICD-11 criteria

Treatment:

Other: Self-questionnaires

Other: Semi-structured interviews ITI and DSCID-II

Other: Cognitive assessment

Other: Momentary Ecological Assessment (EMA)

Group Patients with BPD

Experimental group

Description:

30 Patients with a diagnosis of BPD, according to DSM-5 criteria

Treatment:

Other: Self-questionnaires

Other: Semi-structured interviews ITI and DSCID-II

Other: Cognitive assessment

Other: Momentary Ecological Assessment (EMA)

Group Patients with cPTSD + BPD comorbidity

Experimental group

Description:

30 Patients with cPTSD + BPD comorbidity, established prior to inclusion

Treatment:

Other: Self-questionnaires

Other: Semi-structured interviews ITI and DSCID-II

Other: Cognitive assessment

Other: Momentary Ecological Assessment (EMA)