PTSD Post Traumatic Syndrome Disorder Clinical Trial
— IPPI AOfficial title:
Evaluation of the Effects of Post-Immediate Psychotherapeutic Interventions in Secondary Prevention of Psychotraumatic Disorders
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.
| Status | Recruiting |
| Enrollment | 330 |
| Est. completion date | April 2009 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
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 ßblockers , - 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| France | Hôpital Edouard Herriot - SAMU | Lyon | Rhone-Alpes |
| Lead Sponsor | Collaborator |
|---|---|
| Groupe Francais d'Epidemiologie Psychiatrique |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | PTSD frequency (questionnaire CAPS at 1, 3, 6 and 12 months ) | |||
| Secondary | Complete and subsyndormic PTSD occurence (CAPS at 1, 3, 6 and 12 months) | |||
| Secondary | Intensity of psychotraumatic disorders (Sheehan scale at 1, 3, 6 and 12 months). | |||
| Secondary | Psychopathologic disorder frequency (CIDI SF at baseline and at 1, 3, 6 and 12 months). | |||
| Secondary | Evolution of anxiety/depression (HAD scale after first therapy session and at 1, 3, 6 and 12 months). | |||
| Secondary | Alcoholization frequency (CAGE scale at baseline and at 1, 3, 6 and 12 months). | |||
| Secondary | Frequency of somatic adverse events (at each visit). | |||
| Secondary | Access to health care (number and types of contacts, at each visit). |