Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00455390
Status:
UNKNOWN
Last Update Posted:
2007-04-03
First Post:
2007-04-02
Brief Title:
Evaluation of the Effects of Post-Immediate Psychotherapeutic Interventions in Secondary Prevention of Psychotraumatic Disorders
Sponsor:
Groupe Francais dEpidemiologie Psychiatrique
Organization:
Groupe Francais dEpidemiologie Psychiatrique
Study Overview
Official Title:
Evaluation of the Effects of Post-Immediate Psychotherapeutic Interventions in Secondary Prevention of Psychotraumatic Disorders
Status:
UNKNOWN
Status Verified Date:
2007-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IPPI A
Brief Summary:
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
Mitchells debriefing based upon stress and its theories using cognitive and behavioural approaches
French debriefing post-immediate psychotherapeutic intervention based on the traumatism never realised before second day post event and applied by mental health professionals
The current controversy of the Mitchells 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
To document the efficacy of these interventions regarding professional social and familial adaptation
To identify predictive factors of response to this strategy
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 wont be considered for the study
Outcome measures Primary outcome PTSD frequency on the basis of questionnaire CAPS
Secondary outcome
Complete and subsyndormic PTSD occurence CAPS
Intensity of psychotraumatic disorders Sheehan scale
Psychopathologic disorder frequency CIDI SF
Evolution of anxietydepression HAD scale
Alcoholization frequency CAGE scale
Frequency of somatic adverse events
Access to health care number and types of contacts
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
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
Mitchells debriefing based upon stress and its theories using cognitive and behavioural approaches
French debriefing post-immediate psychotherapeutic intervention based on the traumatism never realised before second day post event and applied by mental health professionals
The current controversy of the Mitchells 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
To document the efficacy of these interventions regarding professional social and familial adaptation
To identify predictive factors of response to this strategy
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 wont be considered for the study
Outcome measures Primary outcome PTSD frequency on the basis of questionnaire CAPS
Secondary outcome
Complete and subsyndormic PTSD occurence CAPS
Intensity of psychotraumatic disorders Sheehan scale
Psychopathologic disorder frequency CIDI SF
Evolution of anxietydepression HAD scale
Alcoholization frequency CAGE scale
Frequency of somatic adverse events
Access to health care number and types of contacts
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
Detailed Description:
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
men or women aged 18 to 65
subjected to a potentially traumatic event criteria A1 DSM IV
having presented an emotional reaction intense fear impotency or horror criteria A2 DSM IV
potentially traumatic event happening within 8 days prior randomization
Non inclusion criteria
patients treated with βblockers
patients suffering from psychopathologic disorders within 15 days prior randomization Axe I DSM IV
physical injuries avoiding patients participation to the study
hospitalization 72 hours post event
traumatic event related to a process of victimisation domestic violences
no informed consent signed
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
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
men or women aged 18 to 65
subjected to a potentially traumatic event criteria A1 DSM IV
having presented an emotional reaction intense fear impotency or horror criteria A2 DSM IV
potentially traumatic event happening within 8 days prior randomization
Non inclusion criteria
patients treated with βblockers
patients suffering from psychopathologic disorders within 15 days prior randomization Axe I DSM IV
physical injuries avoiding patients participation to the study
hospitalization 72 hours post event
traumatic event related to a process of victimisation domestic violences
no informed consent signed
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None