PTSD Post Traumatic Syndrome DisorderPhase 3IPPI ANCT00455390
Evaluation of the Effects of Post-Immediate Psychotherapeutic Interventions in Secondary Prevention of Psychotraumatic Disorders
A Phase 3 study testing Post-immediate Psychotherapeutic Intervention in people with PTSD Post Traumatic Syndrome Disorder, run by Groupe Francais d'Epidemiologie Psychiatrique at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- PTSD Post Traumatic Syndrome Disorder
- What is being tested?
- Post-immediate Psychotherapeutic Intervention
- Type of treatment
- Surgery or procedure
- How many people
- 330 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2007to Apr 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital Edouard Herriot - SAMU
Lyon, Auvergne-Rhône-Alpes, 69100
Nathalie PRIETO, MDH, +33 4 72 11 63 87, nathalie.prieto@chu-lyon.fr
About this study
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 :
Read more
- 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.
Read the 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
- Being tested
- Post-immediate Psychotherapeutic Intervention
- Keywords
- Post immediate Psychotherapeutic Intervention, Psychotraumatic disorders, PTSD post traumatic syndrome disorder, CUMP Cellules d'Urgence Médico Psychologique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post-immediate Psychotherapeutic InterventionProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD frequency (questionnaire CAPS at 1, 3, 6 and 12 months )
Secondary outcomes (7)
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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2007 (estimated)
- Study startJan 2007
- Study completionApr 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSD Post Traumatic Syndrome DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 330 participants
Sponsor and investigators
- Lead sponsor
- Groupe Francais d'Epidemiologie Psychiatrique
- Sponsor type
- University, hospital or other
- Investigators
- Nathalie PRIETO, MDH, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00455390
- Sponsor's protocol ID
- IPPI A
- Acronym
- IPPI A
- Status last verified
- Apr 2007
- First submitted
- 2 Apr 2007
- Last updated
- 3 Apr 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Post-Immediate Psychotherapeutic Interventions in Secondary Prevention of Psychotraumatic Disorders
- ClinicalTrials.gov ID
- NCT00455390
- Acronym / sponsor ID
- IPPI A / IPPI A
- Conditions
- PTSD Post Traumatic Syndrome Disorder
- Keywords
- Post immediate Psychotherapeutic Intervention, Psychotraumatic disorders, PTSD post traumatic syndrome disorder, CUMP Cellules d'Urgence Médico Psychologique
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 330 participants
- Lead sponsor
- Groupe Francais d'Epidemiologie PsychiatriqueUniversity, hospital or other
- Study start
- Jan 2007
- Study completion
- Apr 2009 (estimated)
- First posted
- 3 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Post-immediate Psychotherapeutic Intervention | Procedure or surgery | – |
Primary outcome
PTSD frequency (questionnaire CAPS at 1, 3, 6 and 12 months )
7 secondary outcomes
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathalie PRIETO, MDH principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Post-immediate Psychotherapeutic Intervention in people with PTSD Post Traumatic Syndrome Disorder, run by Groupe Francais d'Epidemiologie Psychiatrique at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-Pierre VIGNAT, MDH (+33 4 37 90 11 75, jpvignat@ch-st-jean-de-dieu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD frequency (questionnaire CAPS at 1, 3, 6 and 12 months ). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2007.