Post Traumatic Stress Disorder and Neural Mechanisms Involved in Its Treatment

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.

Study Overview

• Status: Completed
• Conditions: Post Traumatic Stress Disorders
• Intervention / Treatment: Other: resonance magnetic imaging (fMRI),

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille, France
    • Assistance Publique-Hôpitaux de Marseille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Healthy volunteers; Healthy volunteers without treatment	Other: resonance magnetic imaging (fMRI),; 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)
EXPERIMENTAL: CBT; Psychotraumatized patients treated by Cognitive and Behavioral Therapies (CBT)	Other: resonance magnetic imaging (fMRI),; 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)
EXPERIMENTAL: EMDR; Psychotraumatized patients treated by Eye Movement Desensitization and Reprocessing (EMDR)	Other: resonance magnetic imaging (fMRI),; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To verify the hypothesis of a levying of inhibition of the CPFm on the tonsil, in the PTSD	3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Studies of the peripheral, cognitive and central mechanisms, before, then 1 week and 6 months after treatment by CBT or EMDR	3 years

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (ACTUAL): May 1, 2012

Study Registration Dates

• First Submitted: May 5, 2009
• First Submitted That Met QC Criteria: May 5, 2009
• First Posted (ESTIMATE): May 6, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): August 28, 2014
• Last Update Submitted That Met QC Criteria: August 27, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: Post traumatic stress disorder PTSD
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Trauma and Stressor Related Disorders; Disease; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 2009/01; 2009-A00193-54