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

NCT ID: NCT00455390

Last Updated: 2007-04-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 330 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2009-04-30

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

Conditions

PTSD Post Traumatic Syndrome Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Interventions

Post-immediate Psychotherapeutic Intervention

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Groupe Francais d'Epidemiologie Psychiatrique

OTHER

Sponsor Role: lead

Principal Investigators

Nathalie PRIETO, MDH

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

Hôpital Edouard Herriot - SAMU

Lyon, Auvergne-Rhône-Alpes, France

Site Status: RECRUITING

Countries

France

Central Contacts

Jean-Pierre VIGNAT, MDH

Role: CONTACT

jpvignat@ch-st-jean-de-dieu-lyon.fr

+33 4 37 90 11 75

Facility Contacts

Nathalie PRIETO, MDH

Role: primary

nathalie.prieto@chu-lyon.fr

+33 4 72 11 63 87

Other Identifiers

IPPI A

Identifier Type: -

Identifier Source: org_study_id