Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Argumentation The frequency of post-traumatic syndrome disorder (PTSD) is estimated around 1% of the entire European population. In some specific populations, this percentage increases (soldiers - 15 to 22%, war or persecuted refugees - 80%, post office or bank employees submitted to an hold-up - 17%, firemen - 10 to 30%, emergency care employees - 11%, people who underwent a terrorist attack or any violence - 20 to 65%...)
Prevention is yet poor, secondary prevention trying to avoid a post traumatic disorder apparition early after the traumatic event. There is currently two types of secondary prevention :
The current controversy of the Mitchell's debriefing leads us to evaluate the post-immediate psychotherapeutic intervention, never evaluated yet.
Scientific Objectives Primary objective: To verify that post-immediate psychotherapeutic interventions (proposed after 2 days and before the end of first month post event) decrease incidence, duration and intensity of psychotraumatic disorders at one year, versus a control group.
Secondary objectives :
Method Experimental Design National multicentered, randomized, single blind study Study Population 330 men or women aged 18 to 65, subjected to a potentially traumatic event (criteria A1, DSM IV) and having presented an emotional reaction (intense fear, impotency or horror, criteria A2, DSM IV). This event must have happened within 8 days prior randomization. Patients treated with βblockers and patients suffering from psychopathologic disorders won't be considered for the study.
Outcome measures Primary outcome: PTSD frequency (on the basis of questionnaire CAPS).
Secondary outcome:
Expected benefits The post-immediate psychotherapeutic intervention shall avoid psychological disorders apparition or improve its symptoms. This would decrease consequences on personal life (social, relational and professional).
The study results will allow a better knowledge of these post traumatic disorders.
Intervention:
Group 1: Post-immediate psychotherapeutic intervention, 2 to 3 seances within the first month following the potentially traumatic event. Each intervention last about 45 minutes.
Group 2-control: no psychotherapeutic intervention, only 2 to 3 supporting sessions.
Eligibility criteria:
Inclusion criteria
Non inclusion criteria
Study type:
Randomized, single blind trial on two parallel groups. Randomization stratified on sex and human design.
Number of patients:
330 in 18 clinical centres
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Post-immediate Psychotherapeutic Intervention | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| PTSD frequency (questionnaire CAPS at 1, 3, 6 and 12 months ) |
| Measure | Description | Time Frame |
|---|---|---|
| Complete and subsyndormic PTSD occurence (CAPS at 1, 3, 6 and 12 months) | ||
| Intensity of psychotraumatic disorders (Sheehan scale at 1, 3, 6 and 12 months). | ||
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jean-Pierre VIGNAT, MDH | Contact | +33 4 37 90 11 75 | jpvignat@ch-st-jean-de-dieu-lyon.fr |
| Name | Affiliation | Role |
|---|---|---|
| Nathalie PRIETO, MDH | Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Edouard Herriot - SAMU | Recruiting | Lyon | Auvergne-Rhône-Alpes | 69100 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Psychopathologic disorder frequency (CIDI SF at baseline and at 1, 3, 6 and 12 months). |
| Evolution of anxiety/depression (HAD scale after first therapy session and at 1, 3, 6 and 12 months). |
| Alcoholization frequency (CAGE scale at baseline and at 1, 3, 6 and 12 months). |
| Frequency of somatic adverse events (at each visit). |
| Access to health care (number and types of contacts, at each visit). |