Acute Stress DisorderPREDEKITNCT07850193
Assessment of the Preventive Effect of Defusing on Traumatic Kindling
A study testing Defusing and Psychological First Aid (PFA) in people with Acute Stress Disorder and Post Traumatic Stress Disorder PTSD, run by Hospices Civils de Lyon at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Stress Disorder, Post Traumatic Stress Disorder PTSD
- What is being tested?
- Defusing and Psychological First Aid (PFA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 4 sitesFrance
- Study dates
- 1 Nov 2026to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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 join
- 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 locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites
Centre Hospitalier Métropôle de Savoie
Chambéry, 73000
Catherine DELACHENAL, MD, +33 4 79 96 50 50, catherine.delachenal@ch-metropole-savoie.fr
Camille BEAUVAIS, +33 4 79 68 13 22, camille.beauvais@ch-metropole-savoie.fr
Hopital Edouard Herriot
Lyon, 69437
Philippe VIGNAUD, MD ; PhD, +33 4 72 11 63 96, Philippe.vignaud@chu-lyon.fr
Perrine GALIA, +33 4 72 11 13 11, Perrine.galia@chu-lyon.fr
Centre Hospitalier Annecy Genevois
Metz-Tessy, 74370
Thierry Roupioz, MD, +33 4 50 63 63 63, troupioz@ch-annecygenevois.fr
Anne GHENO, +33 4 50 05 51 19, agheno@ch-annecygenevois.fr
Hôpital Necker Enfants malades AP-HP
Paris, 75015
Gaelle ABGRALL, MD, +33 1 44 49 40 00, gaelle.abgrall@aphp.fr
Maude MARILLIER, +33 1 44 49 24 79, maude.marillier@aphp.fr
About this study
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.
Read more
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
Read the detailed description
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 :
- 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)
- 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
- 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).
- Being tested
- Defusing, Psychological First Aid (PFA)
- Keywords
- acute stress disorder, post traumatic stress disorder, defusing, early intervention, disaster psychiatry, medico-psychological emergency unit
- Medical subject headings
- Stress Disorders, Traumatic, Acute, Combat Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DefusingBehavioural
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
Psychological First Aid (PFA)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Behavioral: Psychological First Aid (PFA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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).
Measured: Twice daily (midday and evening) from Day 1 to Visit 2
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)
Measured: At Visit 2 (Days 7-10 post-event)
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)
Measured: At Visit 2 (Days 7-10 post-event)
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)
Measured: At Visit 2 (Days 7-10 post-event)
Correlations between emotional distress during the recall of the traumatic memory and risk factors for PTSD.
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).
Measured: At Baseline (Day 0) and Visit 2 (Days 7-10 post-event)
PTSD symptoms
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.
Measured: At Visit 3 (Days 30-40 post-event)
Assessment of Social Support Level
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.
Measured: At Visit 3 (Days 30-40 post-event)
Implementation of Psychological Follow-Up Care
Proportion of participants who initiated ongoing professional psychological care/therapy at 1 month post-event.
Measured: At Visit 3 (Days 30-40 post-event)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Stress DisorderStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe VIGNAUD, MD ; PhD, Principal investigator, Central administration : hospices civils de Lyon ; department : medico psychological emergency unit (CUMP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07850193
- Sponsor's protocol ID
- 69HCL25_0844
- Other IDs
- 2026-A01571-50
- Acronym
- PREDEKIT
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Every raw data relevant for the publication will be available for sharing
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Preventive Effect of Defusing on Traumatic Kindling
- ClinicalTrials.gov ID
- NCT07850193
- Acronym / sponsor ID
- PREDEKIT / 69HCL25_0844
- Keywords
- acute stress disorder, post traumatic stress disorder, defusing, early intervention, disaster psychiatry, medico-psychological emergency unit
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 30 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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 :
- 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)
- 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
- 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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Defusing group | Experimental | Behavioral: DefusingA 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. |
| First psychosocial aid (FPA) group | Active comparator | Behavioral: Psychological First Aid (PFA)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DefusingA 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 | Behavioural | Defusing group |
| Psychological First Aid (PFA)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. | Behavioural | First psychosocial aid (FPA) group |
Primary outcome
Level of emotional distress at reminding/reactivation of the traumatic memory
Time frame: 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).
8 secondary outcomes
Ruminative thoughts and intrusive symptoms during the initial follow-up
Time frame: Twice daily (midday and evening) from Day 1 to Visit 2
Physiological Stress Responses During Trauma Recall
Time frame: At Visit 2 (Days 7-10 post-event)
Physiological Stress Responses During Trauma Recall
Time frame: At Visit 2 (Days 7-10 post-event)
Physiological Stress Responses During Trauma Recall
Time frame: At Visit 2 (Days 7-10 post-event)
Correlations between emotional distress during the recall of the traumatic memory and risk factors for PTSD.
Time frame: At Baseline (Day 0) and Visit 2 (Days 7-10 post-event)
PTSD symptoms
Time frame: At Visit 3 (Days 30-40 post-event)
Assessment of Social Support Level
Time frame: At Visit 3 (Days 30-40 post-event)
Implementation of Psychological Follow-Up Care
Time frame: At Visit 3 (Days 30-40 post-event)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: Yes. Every raw data relevant for the publication will be available for sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Philippe VIGNAUD, MD ; PhD principal investigator
Central administration : hospices civils de Lyon ; department : medico psychological emergency unit (CUMP)
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Defusing and Psychological First Aid (PFA) in people with Acute Stress Disorder and Post Traumatic Stress Disorder PTSD, run by Hospices Civils de Lyon at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Philippe VIGNAUD, MD ; PhD (+33 4 72 11 63 96, Philippe.vignaud@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of emotional distress at reminding/reactivation of the traumatic memory (time frame: From Baseline (Day 0) to Visit 2 (Days 7-10 post-event)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.