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Post Traumatic Stress Disorder and Neural Mechanisms Involved in Its Treatment

Primary Purpose

Post Traumatic Stress Disorders

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
resonance magnetic imaging (fMRI),
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Post Traumatic Stress Disorders focused on measuring Post traumatic stress disorder PTSD

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Assistance Publique-Hopitaux de Marseille

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Healthy volunteers

CBT

EMDR

Arm Description

Healthy volunteers without treatment

Psychotraumatized patients treated by Cognitive and Behavioral Therapies (CBT)

Psychotraumatized patients treated by Eye Movement Desensitization and Reprocessing (EMDR)

Outcomes

Primary Outcome Measures

To verify the hypothesis of a levying of inhibition of the CPFm on the tonsil, in the PTSD

Secondary Outcome Measures

Studies of the peripheral, cognitive and central mechanisms, before, then 1 week and 6 months after treatment by CBT or EMDR

Full Information

First Posted
May 5, 2009
Last Updated
August 27, 2014
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT00893568
Brief Title
Post Traumatic Stress Disorder and Neural Mechanisms Involved in Its Treatment
Official Title
Post Traumatic Stress Disorder and Neural Mechanisms Involved in Its Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorders
Keywords
Post traumatic stress disorder PTSD

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy volunteers
Arm Type
Active Comparator
Arm Description
Healthy volunteers without treatment
Arm Title
CBT
Arm Type
Experimental
Arm Description
Psychotraumatized patients treated by Cognitive and Behavioral Therapies (CBT)
Arm Title
EMDR
Arm Type
Experimental
Arm Description
Psychotraumatized patients treated by Eye Movement Desensitization and Reprocessing (EMDR)
Intervention Type
Other
Intervention Name(s)
resonance magnetic imaging (fMRI),
Intervention Description
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)
Primary Outcome Measure Information:
Title
To verify the hypothesis of a levying of inhibition of the CPFm on the tonsil, in the PTSD
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Studies of the peripheral, cognitive and central mechanisms, before, then 1 week and 6 months after treatment by CBT or EMDR
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Assistance Publique-Hopitaux de Marseille
City
Marseille
Country
France

12. IPD Sharing Statement

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