Assessment of the Preventive Effect of Defusing on Traumatic Kindling

NCT07850193 | Not Yet Recruiting

• 2 other identifiers: 69HCL25_08442026-A01571-50
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Acute Stress Disorder; Post Traumatic Stress Disorder PTSD

Keywords

acute stress disorder; post traumatic stress disorder; defusing; early intervention; disaster psychiatry; medico-psychological emergency unit

Outcome Measures

Primary Outcomes (1)

• Level of emotional distress at reminding/reactivation of the traumatic memory

  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)

Secondary Outcomes (8)

• Ruminative thoughts and intrusive symptoms during the initial follow-up

  Twice daily (midday and evening) from Day 1 to Visit 2

• Physiological Stress Responses During Trauma Recall

  At Visit 2 (Days 7-10 post-event)

• Physiological Stress Responses During Trauma Recall

  At Visit 2 (Days 7-10 post-event)

• Physiological Stress Responses During Trauma Recall

  At Visit 2 (Days 7-10 post-event)

• Correlations between emotional distress during the recall of the traumatic memory and risk factors for PTSD.

  At Baseline (Day 0) and Visit 2 (Days 7-10 post-event)

Study Arms (2)

Defusing group

EXPERIMENTAL

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.

Behavioral: Defusing

First psychosocial aid (FPA) group

ACTIVE COMPARATOR

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

Behavioral: Psychological First Aid (PFA)

Interventions

Defusing BEHAVIORAL

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

Defusing group

Psychological First Aid (PFA) BEHAVIORAL

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.

First psychosocial aid (FPA) group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• Acute start or relapse of any comorbid psychiatric condition
• Early care delivered after the first 24 hours following the potential traumatic event
• Suicidal crisis

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (4)

Centre Hospitalier Métropôle de Savoie

Chambéry, 73000, France

Location

Hopital Edouard Herriot

Lyon, 69437, France

Location

Centre Hospitalier Annecy Genevois

Metz-Tessy, 74370, France

Location

Hôpital Necker Enfants malades AP-HP

Paris, 75015, France

Location

MeSH Terms

Conditions

Stress Disorders, Traumatic, Acute; Combat Disorders; Stress Disorders, Post-Traumatic

Interventions

Psychological First Aid

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Emergency Services, Psychiatric; Mental Health Services; Behavioral Disciplines and Activities

Study Officials

• Philippe VIGNAUD, MD ; PhD

  Central administration : hospices civils de Lyon ; department : medico psychological emergency unit (CUMP)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe VIGNAUD, MD ; PhD

CONTACT

+33 4 72 11 63 96; Philippe.vignaud@chu-lyon.fr

Perrine GALIA

CONTACT

+33 4 72 11 13 11; perrine.galia@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2026
• First Posted: September 30, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available 6 months after the publication of the study
• Access Criteria: Data will be shared after direct contact with the main investigator

Locations

FR (4)