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

April 2, 2007 updated by: Groupe Francais d'Epidemiologie Psychiatrique

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment

330

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Rhone-Alpes
      • Lyon, Rhone-Alpes, France, 69100
        • Recruiting
        • Hôpital Edouard Herriot - SAMU
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Francais d'Epidemiologie Psychiatrique

Investigators

  • Principal Investigator: Nathalie PRIETO, MDH, Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Study Completion (Anticipated)

April 1, 2009

Study Registration Dates

First Submitted

April 2, 2007

First Submitted That Met QC Criteria

April 2, 2007

First Posted (Estimate)

April 3, 2007

Study Record Updates

Last Update Posted (Estimate)

April 3, 2007

Last Update Submitted That Met QC Criteria

April 2, 2007

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IPPI A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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