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
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Yksityiskohtainen kuvaus
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).
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Philippe VIGNAUD, MD ; PhD
- Puhelinnumero: +33 4 72 11 63 96
- Sähköposti: Philippe.vignaud@chu-lyon.fr
Tutki yhteystietojen varmuuskopiointi
- Nimi: Perrine GALIA
- Puhelinnumero: +33 4 72 11 13 11
- Sähköposti: perrine.galia@chu-lyon.fr
Opiskelupaikat
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Chambéry, Ranska, 73000
- Centre Hospitalier Métropôle de Savoie
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Ottaa yhteyttä:
- Catherine DELACHENAL, MD
- Puhelinnumero: +33 4 79 96 50 50
- Sähköposti: catherine.delachenal@ch-metropole-savoie.fr
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Ottaa yhteyttä:
- Camille BEAUVAIS
- Puhelinnumero: +33 4 79 68 13 22
- Sähköposti: camille.beauvais@ch-metropole-savoie.fr
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Päätutkija:
- Catherine DELACHENAL, MD
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Lyon, Ranska, 69437
- Hopital Edouard Herriot
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Ottaa yhteyttä:
- Philippe VIGNAUD, MD ; PhD
- Puhelinnumero: +33 4 72 11 63 96
- Sähköposti: Philippe.vignaud@chu-lyon.fr
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Ottaa yhteyttä:
- Perrine GALIA
- Puhelinnumero: +33 4 72 11 13 11
- Sähköposti: Perrine.galia@chu-lyon.fr
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Päätutkija:
- Philippe VIGNAUD, Dr
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Metz-Tessy, Ranska, 74370
- Centre Hospitalier Annecy Genevois
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Ottaa yhteyttä:
- Thierry Roupioz, MD
- Puhelinnumero: +33 4 50 63 63 63
- Sähköposti: troupioz@ch-annecygenevois.fr
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Ottaa yhteyttä:
- Anne GHENO
- Puhelinnumero: +33 4 50 05 51 19
- Sähköposti: agheno@ch-annecygenevois.fr
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Päätutkija:
- Thierry ROUPIOZ, MD
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Paris, Ranska, 75015
- Hôpital Necker Enfants malades AP-HP
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Ottaa yhteyttä:
- Gaelle ABGRALL, MD
- Puhelinnumero: +33 1 44 49 40 00
- Sähköposti: gaelle.abgrall@aphp.fr
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Ottaa yhteyttä:
- Maude MARILLIER
- Puhelinnumero: +33 1 44 49 24 79
- Sähköposti: maude.marillier@aphp.fr
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Päätutkija:
- Gaelle ABGRALL, MD
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Ennaltaehkäisy
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Yksittäinen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: 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 |
|
Active Comparator: 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. |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Level of emotional distress at reminding/reactivation of the traumatic memory
Aikaikkuna: 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)
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Ruminative thoughts and intrusive symptoms during the initial follow-up
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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.
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
|
Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Päätutkija: Philippe VIGNAUD, MD ; PhD, Central administration : hospices civils de Lyon ; department : medico psychological emergency unit (CUMP)
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 69HCL25_0844
- 2026-A01571-50 (Muu tunniste: ID-RCB)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
Every raw data relevant for the publication will be available for sharing
IPD-jaon aikakehys
Data will be available 6 months after the publication of the study
IPD-jaon käyttöoikeuskriteerit
Data will be shared after direct contact with the main investigator
IPD-jakamista tukeva tietotyyppi
- STUDY_PROTOCOL
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Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
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