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

NCT00455390 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2007-04-03

No results posted yet for this study

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.

Conditions

  • PTSD Post Traumatic Syndrome Disorder

Interventions

PROCEDURE

Post-immediate Psychotherapeutic Intervention

Sponsors & Collaborators

  • Groupe Francais d'Epidemiologie Psychiatrique

    lead OTHER

Principal Investigators

  • Nathalie PRIETO, MDH · Hospices Civils de Lyon

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Completion
2009-04-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00455390 on ClinicalTrials.gov