Assessment of the Preventive Effect of Defusing on Traumatic Kindling
Key facts
- Who runs it
- Hospices Civils de Lyon
- Where
- France4 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Not yet recruiting
- People taking part
- 70 people, planned
- Started
- 1 Nov 2026
- Expected to end
- 1 Dec 2028
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Defusing
- Psychological First Aid (PFA)
- Record updated
- 30 September 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- 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
Who cannot take part
- Acute start or relapse of any comorbid psychiatric condition
- Ongoing dissociative symptoms during the study inclusion window (the first 24 hours post-event)
- Early care delivered after the first 24 hours following the potential traumatic event
- Suicidal crisis
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
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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
The 2 groups in the trial
- Defusing groupTreatment being tested
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.
Treatment: Defusing
- First psychosocial aid (FPA) groupExisting treatment, for comparison
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
Treatment: Psychological First Aid (PFA)
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 30 September 2026