Evaluation of the Effects of Post-Immediate Psychotherapeutic Interventions in Secondary Prevention of Psychotraumatic Disorders (IPPI A)
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|ClinicalTrials.gov Identifier: NCT00455390|
Recruitment Status : Unknown
Verified April 2007 by Groupe Francais d'Epidemiologie Psychiatrique.
Recruitment status was: Recruiting
First Posted : April 3, 2007
Last Update Posted : April 3, 2007
|First Submitted Date ICMJE||April 2, 2007|
|First Posted Date ICMJE||April 3, 2007|
|Last Update Posted Date||April 3, 2007|
|Study Start Date ICMJE||January 2007|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||PTSD frequency (questionnaire CAPS at 1, 3, 6 and 12 months )|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Evaluation of the Effects of Post-Immediate Psychotherapeutic Interventions in Secondary Prevention of Psychotraumatic Disorders|
|Official Title ICMJE||Evaluation of the Effects of Post-Immediate Psychotherapeutic Interventions in Secondary Prevention of Psychotraumatic Disorders|
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).
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.
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.
Non inclusion criteria
Randomized, single blind trial on two parallel groups. Randomization stratified on sex and human design.
Number of patients:
330 in 18 clinical centres
|Study Type ICMJE||Interventional|
|Study Phase||Phase 3|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Condition ICMJE||PTSD Post Traumatic Syndrome Disorder|
|Intervention ICMJE||Procedure: Post-immediate Psychotherapeutic Intervention|
|Study Arms||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Unknown status|
|Original Enrollment ICMJE||Same as current|
|Estimated Study Completion Date||April 2009|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years to 65 Years (Adult)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||France|
|Removed Location Countries|
|NCT Number ICMJE||NCT00455390|
|Other Study ID Numbers ICMJE||IPPI A|
|Has Data Monitoring Committee||No|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Groupe Francais d'Epidemiologie Psychiatrique|
|Collaborators ICMJE||Not Provided|
|PRS Account||Groupe Francais d'Epidemiologie Psychiatrique|
|Verification Date||April 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP