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Evaluation of the Effects of Post-Immediate Psychotherapeutic Interventions in Secondary Prevention of Psychotraumatic Disorders (IPPI A)

Primary Purpose

PTSD Post Traumatic Syndrome Disorder

Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Post-immediate Psychotherapeutic Intervention
Sponsored by
Groupe Francais d'Epidemiologie Psychiatrique
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for PTSD Post Traumatic Syndrome Disorder focused on measuring Post immediate Psychotherapeutic Intervention, Psychotraumatic disorders, PTSD post traumatic syndrome disorder, CUMP Cellules d'Urgence Médico Psychologique

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Exclusion Criteria:

  • patients treated with βblockers ,
  • patients suffering from psychopathologic disorders within 15 days prior randomization (Axe I DSM IV),
  • physical injuries avoiding patient's participation to the study,
  • hospitalization > 72 hours post event,
  • traumatic event related to a process of victimisation (domestic violences),
  • no informed consent

Sites / Locations

  • Hôpital Edouard Herriot - SAMURecruiting

Outcomes

Primary Outcome Measures

PTSD frequency (questionnaire CAPS at 1, 3, 6 and 12 months )

Secondary Outcome Measures

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).
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).

Full Information

First Posted
April 2, 2007
Last Updated
April 2, 2007
Sponsor
Groupe Francais d'Epidemiologie Psychiatrique
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1. Study Identification

Unique Protocol Identification Number
NCT00455390
Brief Title
Evaluation of the Effects of Post-Immediate Psychotherapeutic Interventions in Secondary Prevention of Psychotraumatic Disorders
Acronym
IPPI A
Official Title
Evaluation of the Effects of Post-Immediate Psychotherapeutic Interventions in Secondary Prevention of Psychotraumatic Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Unknown status
Study Start Date
January 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Groupe Francais d'Epidemiologie Psychiatrique

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 : Mitchell's 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 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 : 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 won't 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 anxiety/depression (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 patient's 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD Post Traumatic Syndrome Disorder
Keywords
Post immediate Psychotherapeutic Intervention, Psychotraumatic disorders, PTSD post traumatic syndrome disorder, CUMP Cellules d'Urgence Médico Psychologique

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
330 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Post-immediate Psychotherapeutic Intervention
Primary Outcome Measure Information:
Title
PTSD frequency (questionnaire CAPS at 1, 3, 6 and 12 months )
Secondary Outcome Measure Information:
Title
Complete and subsyndormic PTSD occurence (CAPS at 1, 3, 6 and 12 months)
Title
Intensity of psychotraumatic disorders (Sheehan scale at 1, 3, 6 and 12 months).
Title
Psychopathologic disorder frequency (CIDI SF at baseline and at 1, 3, 6 and 12 months).
Title
Evolution of anxiety/depression (HAD scale after first therapy session and at 1, 3, 6 and 12 months).
Title
Alcoholization frequency (CAGE scale at baseline and at 1, 3, 6 and 12 months).
Title
Frequency of somatic adverse events (at each visit).
Title
Access to health care (number and types of contacts, at each visit).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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. Exclusion Criteria: patients treated with βblockers , patients suffering from psychopathologic disorders within 15 days prior randomization (Axe I DSM IV), physical injuries avoiding patient's participation to the study, hospitalization > 72 hours post event, traumatic event related to a process of victimisation (domestic violences), no informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Pierre VIGNAT, MDH
Phone
+33 4 37 90 11 75
Email
jpvignat@ch-st-jean-de-dieu-lyon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathalie PRIETO, MDH
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Edouard Herriot - SAMU
City
Lyon
State/Province
Rhone-Alpes
ZIP/Postal Code
69100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nathalie PRIETO, MDH
Phone
+33 4 72 11 63 87
Email
nathalie.prieto@chu-lyon.fr

12. IPD Sharing Statement

Learn more about this trial

Evaluation of the Effects of Post-Immediate Psychotherapeutic Interventions in Secondary Prevention of Psychotraumatic Disorders

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