Assessment of the Preventive Effect of Defusing on Traumatic Kindling (PREDEKIT)
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
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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 :
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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)
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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
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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).
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Philippe VIGNAUD, MD ; PhD
- Telefonní číslo: +33 4 72 11 63 96
- E-mail: Philippe.vignaud@chu-lyon.fr
Studijní záloha kontaktů
- Jméno: Perrine GALIA
- Telefonní číslo: +33 4 72 11 13 11
- E-mail: perrine.galia@chu-lyon.fr
Studijní místa
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Chambéry, Francie, 73000
- Centre Hospitalier Métropôle de Savoie
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Kontakt:
- Catherine DELACHENAL, MD
- Telefonní číslo: +33 4 79 96 50 50
- E-mail: catherine.delachenal@ch-metropole-savoie.fr
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Kontakt:
- Camille BEAUVAIS
- Telefonní číslo: +33 4 79 68 13 22
- E-mail: camille.beauvais@ch-metropole-savoie.fr
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Vrchní vyšetřovatel:
- Catherine DELACHENAL, MD
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Lyon, Francie, 69437
- Hopital Edouard Herriot
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Kontakt:
- Philippe VIGNAUD, MD ; PhD
- Telefonní číslo: +33 4 72 11 63 96
- E-mail: Philippe.vignaud@chu-lyon.fr
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Kontakt:
- Perrine GALIA
- Telefonní číslo: +33 4 72 11 13 11
- E-mail: Perrine.galia@chu-lyon.fr
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Vrchní vyšetřovatel:
- Philippe VIGNAUD, Dr
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Metz-Tessy, Francie, 74370
- Centre Hospitalier Annecy Genevois
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Kontakt:
- Thierry Roupioz, MD
- Telefonní číslo: +33 4 50 63 63 63
- E-mail: troupioz@ch-annecygenevois.fr
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Kontakt:
- Anne GHENO
- Telefonní číslo: +33 4 50 05 51 19
- E-mail: agheno@ch-annecygenevois.fr
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Vrchní vyšetřovatel:
- Thierry ROUPIOZ, MD
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Paris, Francie, 75015
- Hôpital Necker Enfants malades AP-HP
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Kontakt:
- Gaelle ABGRALL, MD
- Telefonní číslo: +33 1 44 49 40 00
- E-mail: gaelle.abgrall@aphp.fr
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Kontakt:
- Maude MARILLIER
- Telefonní číslo: +33 1 44 49 24 79
- E-mail: maude.marillier@aphp.fr
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Vrchní vyšetřovatel:
- Gaelle ABGRALL, MD
-
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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. |
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 |
|
Aktivní komparátor: 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 |
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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Level of emotional distress at reminding/reactivation of the traumatic memory
Časové okno: 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)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Ruminative thoughts and intrusive symptoms during the initial follow-up
Časové okno: 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
Časové okno: 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)
|
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Physiological Stress Responses During Trauma Recall
Časové okno: 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
Časové okno: 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.
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Philippe VIGNAUD, MD ; PhD, Central administration : hospices civils de Lyon ; department : medico psychological emergency unit (CUMP)
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 69HCL25_0844
- 2026-A01571-50 (Jiný identifikátor: ID-RCB)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Every raw data relevant for the publication will be available for sharing
Časový rámec sdílení IPD
Data will be available 6 months after the publication of the study
Kritéria přístupu pro sdílení IPD
Data will be shared after direct contact with the main investigator
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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