Post Traumatic Stress Disorder and Neural Mechanisms Involved in Its Treatment
2 other identifiers
interventional
62
1 country
1
Brief Summary
The post traumatic stress disorder PTSD arises when the physiological response to stress does not come to its term. This study aims to explore the cognitive, psycho physiological and cerebral mechanisms involved in PTSD, in fear conditioning and face matching tasks, before and after treatment.PTSD patients will be recruited by Pr Jean-Claude Samuelian in his service at the Conception Hospital and by Pr Jean-Michel Azorin in his service at the Sainte Marguerite Hospital (Marseille) and will undergo either CBT or EMDR within those same services. The tasks they will be asked to perform will study the psycho physiological, cognitive and central mechanisms involved in PTSD and its treatment. All in all, 17 healthy controls will be recruited as well as 17 PTSD patients for each of the two treatment group.In terms of perspectives, this study would help isolate neural systems functionally involved in PTSD and its treatment. A better knowledge of those mechanisms would set room for the optimization of the current PTSD treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 5, 2009
CompletedFirst Posted
Study publicly available on registry
May 6, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedAugust 28, 2014
August 1, 2014
3.1 years
May 5, 2009
August 27, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To verify the hypothesis of a levying of inhibition of the CPFm on the tonsil, in the PTSD
3 years
Secondary Outcomes (1)
Studies of the peripheral, cognitive and central mechanisms, before, then 1 week and 6 months after treatment by CBT or EMDR
3 years
Study Arms (3)
Healthy volunteers
ACTIVE COMPARATORHealthy volunteers without treatment
CBT
EXPERIMENTALPsychotraumatized patients treated by Cognitive and Behavioral Therapies (CBT)
EMDR
EXPERIMENTALPsychotraumatized patients treated by Eye Movement Desensitization and Reprocessing (EMDR)
Interventions
a cerebral study will be performed at the neuroanatomic and functional levels by resonance magnetic imaging (fMRI) realized in three times (before, one week and six months after treatment)
Eligibility Criteria
You may qualify if:
- French speakers
- Not hospitalized grown-up patients suffering from a post-traumatic stress disorder ( PTSD) connected to one event.
- Subjects Controls: grown-up, mated with the patients in age (18 - 50 years; 4 years maximum of difference of age between a patient and his control), in sex and educational level (schooling of the 3rd level, at the level Bac+8; 3 years maximum of difference of educational level between a patient and his control)
You may not qualify if:
- Pregnancy
- Feeding
- Nobody under guardianship and grown-up persons being the object of a legal protective measure or not able to express their assent
- Alcoholic or addicted to drugs (including medicines)
- Other neurological disorders or psychiatric that post-traumatic stress disorder (for patients)
- Claustrophobia and contraindications in the IRMf
- Subjects controls, no known psychiatric or neurological pathology, as well as no psychiatric history.
- Persons private of freedom by a court or administrative order, persons hospitalized without assent
- Unability to read French
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assistance Publique-Hopitaux de Marseille
Marseille, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 5, 2009
First Posted
May 6, 2009
Study Start
April 1, 2009
Primary Completion
May 1, 2012
Last Updated
August 28, 2014
Record last verified: 2014-08