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临床试验/NCT05592652
NCT05592652已完成不适用

Identification of the Clinical Specificities of Complex Posttraumatic Stress Disorder

University Hospital, Tours1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2023年1月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
300
试验地点
1
主要终点
Dissociation

研究概览

简要总结

Identification of the clinical specificities of complex post-traumatic stress disorder post-traumatic stress disorder

详细描述

In general, the current state of the literature in the field the lack of data on elements of characterization of PTSD compared to simple PTSD, which are which are essential for deciding on the discriminatory validity of discriminative validity of PTSD as a disorder in its own right disorder in its own right. The challenge of defining the nosographic scope of this disorder is twofold, since the links between diagnosis and treatment are decisive for developing treatments adapted to the treatments adapted to the psychopathology of the patients. These characterization elements are therefore crucial in order to improve the perspective of improving the effectiveness of future treatment which are currently lacking in TSPTC.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
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

  • •Age ≥ 18 years
  • •Free, informed and signed consent
  • •Affiliated to a social security scheme
  • •Inclusion Criteria volonteer :
  • •Age ≥ 18 years
  • •Free, informed and signed consent
  • •Affiliated to a social security scheme

排除标准

  • •(patient and volonteer):
  • •Under legal protection (curatorship, guardianship, safeguard of justice)
  • •Present a former or current psychotic disorder, a former or current neurological disease, a history of head trauma (loss of consciousness of more than 10 minutes)

研究组 & 干预措施

simple post-traumatic stress disorder

Other

Patients suffering from PTSD according to DSM-5 diagnostic features

干预措施: Survey (Other)

complex post-traumatic stress disorder

Other

Patients suffering from CPTSD according to CIM-11 diagnostic features

干预措施: Survey (Other)

volonteer trauma +

Other

non clinical volunteer with traumatic exposure

干预措施: Survey (Other)

volonteer trauma -

Other

non clinical volunteer without traumatic exposure

干预措施: Survey (Other)

结局指标

主要结局

Dissociation

时间窗: baseline

The Dissociation questionnaire (DIS-Q; Vanderlinden et al., 1993) is used to scan dissociative experience and disruptions, and to measure their severity. It can be used for psychiatric patients, individuals with traumatic experience, and for scanning purposes. Its instructions are available in the introduction section of the scale and patients are asked to mark the most appropriate option for their condition. It consists of a total of 63 questions and the subject marks one option for each of these questions. Each item is scored between 1 and 5 points, mean score is obtained by dividing total scores by 63. High scores reflect high dissociative experience and disruptions. This scale can distinguish the subjects with dissociative disorder from healthy individuals or from patients with schizophrenia or bipolar mood disorder.

Emotional dysregulation

时间窗: 5 minutes for questionnaire completion

The Difficulties in Emotion Regulation Scale (DERS; Gratz \& Roemer, 2004) is a 36-item self-report questionnaire assessing emotion regulation difficulties. A typical item is "I am clear about my feelings". Items are rated from 1 (almost never) to 5 (almost always). The French version has good internal consistency for all the sub-dimensions, with Cronbach alpha values of 0.84 to 0.90 (Dan-Glauser \& Scherer, 2013). The DERS provides a total score and higher values are associated with a stronger emotion regulation difficulties.

PTSD

时间窗: baseline

The Posttraumatic stress disorder Checklist Scale PCL-5 (Weathers et al., 2013) is a self-administered questionnaire to assess the severity of PTSD in the clinic and research according to DSM-5 criteria. This scale translated and validated in French (Ashbaugh et al., 2016) is composed of 20 items, rated from 1 (not at all) to 5 (very often) according to the intensity and frequency of symptoms in the past month. When adding the scores for each of the 20 items, a total score greater than or equal to 33 indicates probable PTSD. The PCL-5 has good psychometric qualities as it demonstrates strong internal consistency (α = .94) as well as good convergent (rs = .74 to .85) and divergent validity (rs = .31 to .60) (Blevins et al., 2015). This tool is also sensitive to therapeutic change and can be used in repeated measures as evidenced by strong test-retest reliability (r = .82) (Blevins et al., 2015).

Complex PTSD

时间窗: baseline

The International Trauma Questionnaire (ITQ; Cloitre et al., 2018) is a self-report measure of PTSD and CPTSD severity assessing the following symptoms : reeexperiencing, avoidance, sense of threat, affective dysregulation, negative self- concept and disturbances in relationships. Participants are asked to select on a Likert scale how much a symptom has been bothersome in the past month or how true certain statements are of them, with scores ranging from 0 ("not at all") to 4 ("extremely"). Diagnosis of PTSD requires the endorsement of one of two symptoms from each PTSD cluster, while CPTSD diagnosis requires the endorsement of one of two symptoms from both PTSD and 'Disturbances in Self-organization' clusters. Both diagnoses require the presence of functional impairment. The ITQ is the only validated measure for ICD-11 PTSD and CPTSD.

次要结局

  • Peritraumatic Dissociation(Less than five minutes for questionnaire completion)
  • Depressive symptoms(baseline)
  • Resilience(baseline)
  • Early Maladaptive Schema(10 minutes for questionnaire completion)
  • Personality Disorders(baseline)
  • Peritraumatic Distress(baseline)
  • Childhood Trauma(baseline)
  • Well Being(baseline)
  • Alcohol misuse(baseline)
  • Anxiety State and Trait(baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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