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

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00455390
Acronym
IPPI A
Enrollment
330
Registered
2007-04-03
Start date
2007-01-31
Completion date
2009-04-30
Last updated
2007-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PTSD Post Traumatic Syndrome Disorder

Keywords

Post immediate Psychotherapeutic Intervention, Psychotraumatic disorders, PTSD post traumatic syndrome disorder, CUMP Cellules d'Urgence Médico Psychologique

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

Interventions

PROCEDUREPost-immediate Psychotherapeutic Intervention

Sponsors

Groupe Francais d'Epidemiologie Psychiatrique
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
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).

Countries

France

Contacts

Primary ContactJean-Pierre VIGNAT, MDH
jpvignat@ch-st-jean-de-dieu-lyon.fr+33 4 37 90 11 75

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026