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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 170
- 主要终点
- Characterizing the emotional pattern
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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).
研究组 & 干预措施
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.
干预措施: Cognitive assessment (Other)
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.
干预措施: Momentary Ecological Assessment (EMA) (Other)
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.
干预措施: Self-questionnaires (Other)
Group Patients with cPTSD
30 Patients diagnosed with cPTSD according to ICD-11 criteria
干预措施: Self-questionnaires (Other)
Group Patients with cPTSD
30 Patients diagnosed with cPTSD according to ICD-11 criteria
干预措施: Cognitive assessment (Other)
Group Patients with cPTSD
30 Patients diagnosed with cPTSD according to ICD-11 criteria
干预措施: Momentary Ecological Assessment (EMA) (Other)
Group Patients with cPTSD
30 Patients diagnosed with cPTSD according to ICD-11 criteria
干预措施: Semi-structured interviews ITI and DSCID-II (Other)
Group Patients with PTSD
30 Patients diagnosed with PTSD according to ICD-11 criteria
干预措施: Momentary Ecological Assessment (EMA) (Other)
Group Patients with PTSD
30 Patients diagnosed with PTSD according to ICD-11 criteria
干预措施: Semi-structured interviews ITI and DSCID-II (Other)
Group Patients with PTSD
30 Patients diagnosed with PTSD according to ICD-11 criteria
干预措施: Cognitive assessment (Other)
Group Patients with PTSD
30 Patients diagnosed with PTSD according to ICD-11 criteria
干预措施: Self-questionnaires (Other)
Group Patients with BPD
30 Patients with a diagnosis of BPD, according to DSM-5 criteria
干预措施: Self-questionnaires (Other)
Group Patients with BPD
30 Patients with a diagnosis of BPD, according to DSM-5 criteria
干预措施: Cognitive assessment (Other)
Group Patients with BPD
30 Patients with a diagnosis of BPD, according to DSM-5 criteria
干预措施: Momentary Ecological Assessment (EMA) (Other)
Group Patients with BPD
30 Patients with a diagnosis of BPD, according to DSM-5 criteria
干预措施: Semi-structured interviews ITI and DSCID-II (Other)
Group Patients with cPTSD + BPD comorbidity
30 Patients with cPTSD + BPD comorbidity, established prior to inclusion
干预措施: Cognitive assessment (Other)
Group Patients with cPTSD + BPD comorbidity
30 Patients with cPTSD + BPD comorbidity, established prior to inclusion
干预措施: Momentary Ecological Assessment (EMA) (Other)
Group Patients with cPTSD + BPD comorbidity
30 Patients with cPTSD + BPD comorbidity, established prior to inclusion
干预措施: Semi-structured interviews ITI and DSCID-II (Other)
Group Patients with cPTSD + BPD comorbidity
30 Patients with cPTSD + BPD comorbidity, established prior to inclusion
干预措施: Self-questionnaires (Other)
结局指标
主要结局
Characterizing the emotional pattern
时间窗: Day 1
Comparison of DERS scores in groups ( an effect size of 0.37 for the means of DERS by group)
次要结局
- Understand the entire clinical picture of cPTSD(Up to 3 years)
- The evolution of emotional dynamics, assessed in daily life, after treatment psychotherapy in routine care(Up to 3 years)
- Assessing subjective differences in real-life emotional experience(From Day 14 till Day 21)
- The evolution of self-reported emotional dysregulation after psychotherapeutic treatment in routine care(Up to 3 years)
- The evolution of cognitive functioning underlying emotional dysregulation, after Psychotherapeutic treatment in routine care(Up to 3 years)
- The concordance between cognitive and physiological measures of dysregulation Emotional(Up to 3 years)
- Evaluate physiological responses in hospital consultations and in real life(From Day 7 to Day 14)
- Evaluate emotional 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)
- The evolution of physiological emotional responses, assessed in daily life and in consultation, after psychotherapeutic treatment in routine care(Up to 3 years)
- Investigate the concordance between subjective and physiological measures of dysregulation Emotional(Up to 3 years)
- The association between subjective and cognitive measures of emotional dysregulation(Up to 3 years)