이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

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

2026년 9월 29일 업데이트: 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

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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).

연구 유형

중재적

등록 (추정된)

70

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

  • 프랑스
      • Chambéry, 프랑스, 73000
      • Lyon, 프랑스, 69437
        • Hopital Edouard Herriot
        • 연락하다:
        • 연락하다:
        • 수석 연구원:
          • Philippe VIGNAUD, Dr
      • Metz-Tessy, 프랑스, 74370
      • Paris, 프랑스, 75015
        • Hôpital Necker Enfants malades AP-HP
        • 연락하다:
        • 연락하다:
        • 수석 연구원:
          • Gaelle ABGRALL, MD

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
행동: 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
활성 비교기: 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
행동: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Level of emotional distress at reminding/reactivation of the traumatic memory
기간: 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)

2차 결과 측정

결과 측정
측정값 설명
기간
Ruminative thoughts and intrusive symptoms during the initial follow-up
기간: 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
기간: 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
기간: 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
기간: 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.
기간: 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
기간: 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
기간: 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
기간: 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)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Hospices Civils de Lyon

수사관

  • 수석 연구원: Philippe VIGNAUD, MD ; PhD, Central administration : hospices civils de Lyon ; department : medico psychological emergency unit (CUMP)

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 11월 1일

기본 완료 (추정된)

2028년 11월 1일

연구 완료 (추정된)

2028년 12월 1일

연구 등록 날짜

최초 제출

2026년 9월 22일

QC 기준을 충족하는 최초 제출

2026년 9월 29일

처음 게시됨 (실제)

2026년 9월 30일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 30일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 29일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 69HCL25_0844
  • 2026-A01571-50 (기타 식별자: ID-RCB)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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

IPD 공유 기간

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

IPD 공유 액세스 기준

Data will be shared after direct contact with the main investigator

IPD 공유 지원 정보 유형

  • 연구_프로토콜

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다