Assessment of the Preventive Effect of Defusing on Traumatic Kindling
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospices Civils de Lyon
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Defusing
BehavioralA 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
Psychological First Aid (PFA)
BehavioralPFA 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.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Defusing groupExperimental treatment 1 intervention
Group B: First psychosocial aid (FPA) groupActive comparator 1 intervention
Trial outcomes
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).
Time frame
From Baseline (Day 0) to Visit 2 (Days 7-10 post-event)Secondary outcomes
1
Ruminative thoughts and intrusive symptoms during the initial follow-up
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).
Time frame
Twice daily (midday and evening) from Day 1 to Visit 22
Physiological Stress Responses During Trauma Recall
Blood pressure assessed before, during, and after the narrative recall of the traumatic memory at Visit 2 (Days 7-10 after the PTE)
Time frame
At Visit 2 (Days 7-10 post-event)3
Physiological Stress Responses During Trauma Recall
Heart rate assessed before, during, and after the narrative recall of the traumatic memory at Visit 2 (Days 7-10 after the PTE)
Time frame
At Visit 2 (Days 7-10 post-event)4
Physiological Stress Responses During Trauma Recall
Electrodermal activity (EDA) assessed before, during, and after the narrative recall of the traumatic memory at Visit 2 (Days 7-10 after the PTE)
Time frame
At Visit 2 (Days 7-10 post-event)Sponsors and contacts
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Source ClinicalTrials.gov
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