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Assessment of the Preventive Effect of Defusing on Traumatic Kindling (PREDEKIT)

2026年9月29日 更新者：Hospices Civils de Lyon

The exposure to a potential traumatic event (PTE) is common in the general population. This exposure may lead to psychiatric disorders such as acute stress disorder (ASD) and post-traumatic stress disorder (PTSD). Previous exposure to PTE is a well-known risk factor for ASD and PTSD. This may rely on the so called "kindling" which consists in a increasing sensitization of thememory circuits and emotional regulation through this previous and/or repeated exposure.

An early psychological intervention may prevent these diseases or at least decrease the symptoms and improve functional functioning. Defusing is an early and brief psychotherapeutic interview technique which aims at encouraging a victim exposed to a PTE to express her/his own experience concerning the PTE. Some preliminary results reported that defusing could alleviate the emotional distress induced by a PTE.

The PREDEKIT study hypothesizes that defusing prevents the sensitization (kindling) induced by a potentially traumatic event. This study is a prospective, randomized, controlled, multicenter trial with blinded outcome assessment. Participants can be included in the study they are exposed to a PTE and tif they can receive a defusing intervention in the very early phase following the PTE (first 24 hours). The test group will receive defusing while the control group will receive First Psychosocial Aid

Primary and secondary outcomes will assess emotional distress, intrusive symptoms, physiological outcomes relevant for the stress response (blood pressure, heart rate, electrodermal activity). The last evaluation takes place 1 month after the PTE

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

This is a multicenter, parallel-group, open-label controlled study with single blinded assessment.

Visit 1: Following a traumatic event (TE), the investigator team will be deployed to the scene (when indicated by the pre hospital emergency service) and will have the opportunity to meet the victims in the first 24h following the event. The investigators are mental health professionnals (nurses, psychologists ans psychiatrists) and all trained in defusing and briefed on the study protocol. One professional will be designated as the investigator leader for the intervention to manage the participants randomization into one of two possible arms:

  • the control group: First Psychological Aid FPA (i.e., the immediate victim assistance procedure recommended by the WHO, which does not include a specific psychological intervention); or
  • the experimental group: defusing. For patients in the experimental group, the defusing session conducted by a trained clinician (see above) takes place immediately after randomization.

FPA significantly differs from the defusing. This involves ensuring that basic needs are met: hunger, thirst, warmth/protection from cold, basic hygiene, and the ability to return home alone or with assistance. If needed, the caregiver links the victim to the appropriate resource For all study participants, several outcomes are measured at that timing

  • emotional distress will be measured using a visual analogue scale VAS (from 0 to 10).
  • PDEQ (Peritraumatic Dissociative Experiences Questionnaire) and PDI (Peritraumatic Distress Inventory) self-report questionnaires.
  • Demographic and clinical data will be collected: age, gender, family situation, education level, type of TE (natural or industrial disaster, terrorist attack, workplace accident, etc.), and type of exposure to the TE
  • The included participants will also receive a symptom montoring form to bring back to Visit 2 (V2). Participants will have to perform a daily self-assessment-twice a day (at midday and in the evening before bedtime)-for the 7 days following the TE, concerning the following dimensions:
  • Intrusive symptoms: assessing the presence of involuntary visual images of the stressful experience (visual flashes; rated from 0-not at all-to 4-extremely).
  • Rumination episodes: non-visual memories and distressing, involuntary thoughts regarding the stressful experience (Likert scale range 0 to 4).
  • Emotional distress associated with the TE (VAS from 0 to 10).
  • Nightmares related to the event occurring the previous night (Likert scale range 0 to 4).

Visit 2 : taking place between Day 7 and Day 10 after the TE, in laboratory. It is composed of the following steps :

  1. Baseline assessments

    • Emotional distress associated with the TE (VAS from 0 to 10).
    • Blood pressure (BP) and heart rate (HR)
    • Electrodermal activity (EDA) recorded over 5 minutes
    • Psychometric assessment Impact of Event Scale-Revised (IES-R) ; the Life Events Checklist for DSM-5 (LEC-5). -
    • While the participant is filling these questionnnaires, EDA will be recorded continuously, BP and HR will be assessed (5 minutes after the start of the scale administration)

  2. The narrative : the participant will be have to expose again the traumatic event (TE) that led to their inclusion in the study. Concerning the narrative, the interview with the investigator will be stantardized so that the narrative will last at least 10 minutes and reactivate the memory of the TE as high as possible.

    • EDA will be recorded continuously
    • BP and HR will be assessed 5 minutes after the start of the narrative

  3. After the narrative, emotional distress (VAS from 0 to 10), BP, HR and EDA (10 minutes supplementary) will be recorder

Visit 3: taking place between Day 30 and Day 40 post TE by phone. It is composed of the following assessments :

  • Emotional distress associated with the TE (VAS from 0 to 10).
  • Standardized psychometric scales : PCL-5 (PTSD Checklist for DSM-5); SPS-10 (Social Provisions Scale - 10 items).

研究类型

介入性

注册 (估计的)

70

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 法国
      • Chambéry、法国、73000
      • Lyon、法国、69437
        • Hopital Edouard Herriot
        • 接触：
        • 接触：
        • 首席研究员：
          • Philippe VIGNAUD, Dr
      • Metz-Tessy、法国、74370
      • Paris、法国、75015
        • Hôpital Necker Enfants malades AP-HP
        • 接触：
        • 接触：
        • 首席研究员：
          • Gaelle ABGRALL, MD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Exposure to a potentially traumatic event as a direct victim/participant or as a witness
  • Defusing can be delivered in the first 24 hours following the potential traumatic event
  • Available to attend a consultation at the CUMP (Cellule d'Urgence Médico-Psychologique) premises within 7 to 10 days (Visit 2)
  • Age ≥ 18 years
  • Affiliated with or a beneficiary of a social security scheme
  • Sufficient understanding of the French language
  • Ability to provide written, signed, free and informed consent

Non inclusion Criteria :

  • Pregnant, parturient, or breastfeeding women
  • Persons deprived of liberty by a judicial or administrative decision
  • Adults subject to a legal protection measure (guardianship, curatorship, family authorization)
  • Persons not affiliated with or not beneficiaries of a social security scheme
  • Participation in another interventional study with an exclusion period still ongoing at inclusion, notably a clinical trial involving the administration of psychoactive, psychotropic, or cardiotropic drugs

Exclusion Criteria :

  • Ongoing dissociative symptoms during the study inclusion window (the first 24 hours post-event)
  • Acute start or relapse of any comorbid psychiatric condition
  • Early care delivered after the first 24 hours following the potential traumatic event
  • Suicidal crisis

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：Defusing group

A brief (usually not longer than 20 minutes) structured interview conducted by a trained clinician (psychiatrist, psychologist, nurse in mental health) within the 24 hours following potential traumatic event (PTE). It focuses on narrative recall of the event (cognitive and emotional experience). It also commonly includes preliminary psychoeducation on common post-traumatic reactions, and support the activation of the resilience resources.
行为的：Defusing

A brief (usually not longer than 20 minutes) structured interview conducted by a trained clinician (psychiatrist, psychologist, nurse in mental health) within the 24 hours following potential traumatic event (PTE). It focuses on narrative recall of the event (cognitive and emotional experience). It also commonly includes preliminary psychoeducation on common post-traumatic reactions, and support the activation of the resilience resources
有源比较器：First psychosocial aid (FPA) group

Immediate support, based on World Health Organization (WHO) guidelines, dedicated to victims exposure to a collective disaster. It focuses on identifying the immediate needs (comfort, safety, medical or psychological care) of the victim in order to link him/her to the appropriate support/ressource. It does not include any psychotherapeutic intervention
行为的：Psychological First Aid (PFA)

PFA is an immediate support, based on World Health Organization (WHO) guidelines, dedicated to victims exposure to a collective disaster. It focuses on identifying the immediate needs (comfort, safety, medical or psychological care) of the victim in order to link him/her to the appropriate support/ressource. It does not include any psychotherapeutic intervention In addition, the participants are informed on the available psychotraumatism focused psychological care which can be delivered after the Visit 2.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Level of emotional distress at reminding/reactivation of the traumatic memory
大体时间：From Baseline (Day 0) to Visit 2 (Days 7-10 post-event)

Emotional distress is self-reported on an 11-point Visual Analogue Scale (VAS) ranging from 0 ("no distress") to 10 ("extreme distress"). The assessment is performed following a triggered recall of the traumatic memory at Visit 2 (Days 7-10) and compared to baseline (inclusion).
From Baseline (Day 0) to Visit 2 (Days 7-10 post-event)

次要结果测量

结果测量
措施说明
大体时间
Ruminative thoughts and intrusive symptoms during the initial follow-up
大体时间：Twice daily (midday and evening) from Day 1 to Visit 2

Daily scores recorded twice daily (midday and bedtime) on a tracking log for 7 consecutive days following the potential traumatic event. Includes emotional distress (VAS 0-10) and frequency/severity of intrusive psychotraumatic symptoms (visual intrusive symptoms, ruminations, and nightmares, rated 0-4).
Twice daily (midday and evening) from Day 1 to Visit 2
Physiological Stress Responses During Trauma Recall
大体时间：At Visit 2 (Days 7-10 post-event)

Blood pressure assessed before, during, and after the narrative recall of the traumatic memory at Visit 2 (Days 7-10 after the PTE)
At Visit 2 (Days 7-10 post-event)
Physiological Stress Responses During Trauma Recall
大体时间：At Visit 2 (Days 7-10 post-event)

Heart rate assessed before, during, and after the narrative recall of the traumatic memory at Visit 2 (Days 7-10 after the PTE)
At Visit 2 (Days 7-10 post-event)
Physiological Stress Responses During Trauma Recall
大体时间：At Visit 2 (Days 7-10 post-event)

Electrodermal activity (EDA) assessed before, during, and after the narrative recall of the traumatic memory at Visit 2 (Days 7-10 after the PTE)
At Visit 2 (Days 7-10 post-event)
Correlations between emotional distress during the recall of the traumatic memory and risk factors for PTSD.
大体时间：At Baseline (Day 0) and Visit 2 (Days 7-10 post-event)

Correlation Scores between post-recall the variation of the emotional distress score (VAS ; from baseline to Visit 2) and the following psychometric scales: Peritraumatic Dissociative Experiences Questionnaire (PDEQ, score range 9-45), Peritraumatic Distress Inventory (PDI, score range 0-52), Life Events Checklist for DSM-5 (LEC-5), and Impact of Event Scale-Revised (IES-R, score range 0-88).
At Baseline (Day 0) and Visit 2 (Days 7-10 post-event)
PTSD symptoms
大体时间：At Visit 3 (Days 30-40 post-event)

Post-Traumatic Stress Disorder Checklist for DSM-5 (PCL-5) score assessed via telephone interview. Il includes 20 items rated on a 5-point Likert scale (total score range 0-80), higher scores indicating greater symptom severity.
At Visit 3 (Days 30-40 post-event)
Assessment of Social Support Level
大体时间：At Visit 3 (Days 30-40 post-event)

Social Provisions Scale 10-item version (SPS-10) administered via telephone interview. Items rated on a 4-point scale (total score range 10-40), higher scores reflecting greater perceived social support.
At Visit 3 (Days 30-40 post-event)
Implementation of Psychological Follow-Up Care
大体时间：At Visit 3 (Days 30-40 post-event)

Proportion of participants who initiated ongoing professional psychological care/therapy at 1 month post-event.
At Visit 3 (Days 30-40 post-event)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Hospices Civils de Lyon

调查人员

  • 首席研究员：Philippe VIGNAUD, MD ; PhD、Central administration : hospices civils de Lyon ; department : medico psychological emergency unit (CUMP)

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年11月1日

初级完成 (估计的)

2028年11月1日

研究完成 (估计的)

2028年12月1日

研究注册日期

首次提交

2026年9月22日

首先提交符合 QC 标准的

2026年9月29日

首次发布 (实际的)

2026年9月30日

研究记录更新

最后更新发布 (实际的)

2026年9月30日

上次提交的符合 QC 标准的更新

2026年9月29日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 69HCL25_0844
  • 2026-A01571-50 (其他标识符：ID-RCB)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

Every raw data relevant for the publication will be available for sharing

IPD 共享时间框架

Data will be available 6 months after the publication of the study

IPD 共享访问标准

Data will be shared after direct contact with the main investigator

IPD 共享支持信息类型

  • 研究方案

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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