Identification of Markers of Post-Traumatic Stress Disorder (PTSD) Relapse
Primary Purpose
Post Traumatic Stress Disorder (PTSD)
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Neuropsychological assessment
Sponsored by
About this trial
This is an interventional diagnostic trial for Post Traumatic Stress Disorder (PTSD)
Eligibility Criteria
For children
Inclusion Criteria:
- Children (9/18 years)
- Patients who have lived a traumatic event (physical assault and road accident) and who have a PTSD.
- French speaker.
- Participants must sign the informed consent and they must be affiliated to the social insurance.
Exclusion Criteria
- Children who have a neurological pathology.
- Children who have brain damage or brain-injured
- Subject having participated in a biomedical research in three months preceding the inclusion
Sites / Locations
- CHU de NICERecruiting
- Fondation LenvalRecruiting
- CHU de TOULOUSE
- CHU de TOURSRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
In remission phase of PTSD
Activ PTSD
Arm Description
Patients having suffered from PTSD in the past and in remission od PTSD and their parents
patients suffering from PTSD (Post-traumatic Stress Disorder) and their parents
Outcomes
Primary Outcome Measures
Attentional score
Go-No/Go and visual search tests
Secondary Outcome Measures
memory (Grober and Buschke)
Grober and Buschke memory tests
Full Information
NCT ID
NCT01545505
First Posted
December 8, 2011
Last Updated
February 20, 2013
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT01545505
Brief Title
Identification of Markers of Post-Traumatic Stress Disorder (PTSD) Relapse
Official Title
Early Diagnosis of Risk of Post-Traumatic Stress Disorder (PTSD) Relapse in Children and Their Families
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Unknown status
Study Start Date
October 2012 (undefined)
Primary Completion Date
October 2013 (Anticipated)
Study Completion Date
July 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Relapse of post-traumatic stress disorder (PTSD) remains challenging. In addition, factors predicting PTSD relapse are still unknown. The aim of this study is to examine whether clinical and neuropsychological changes (e.g., attentional bias toward aversive cues) that characterized PTSD can be observed in people with past PTSD (children and their families) and whether these persistent changes are predictive of PTSD relapse.
Detailed Description
One of the great challenges in Psychotraumatology is the high risk (20-40%) of post-traumatic stress disorder (PTSD) relapse, which markers remain understudied. Identification of these markers is of particular interest for the development of strategies to prevent relapse. Based on clinical and experimental data, it appears that (i) the so-called residual clinical symptoms (such as sleep disturbance, irritability) and (ii) the neuropsychological dysfunctions (cognitive difficulties), persisting after remission, may constitute markers of PTSD relapse. Moreover, all of these potential markers have also been linked with dysfunctions, persisting or reoccurring, in the prefrontal cortex after remission.
The main objective of this study is to identify these clinical and neuropsychological markers of PTSD relapse in children and their families. The secondary objective is to demonstrate the link between prefrontal dysfunctions and relapse.
This longitudinal study will include 4 experimental groups:
30 children with PTSD
30 children with past PTSD (children in remission)
30 parents of children with PTSD
30 parents of children with past PTSD The first visit is planned during the symptomatic phase (T0). The second visit (T1) is planned at the end of the symptomatic phase (or 6 months later T0). The last visit is planned 3-months after T1.
The psychological assessment will include:
A structured interview with a psychiatrist An assessment of PTSD symptoms (IES-R, CPTS-RI for children) An assessment of the co-morbidity (STAI C and CDI for children, STAI A-B, BDI for adults).
An evaluation of the social life (EAS for children and SAS-SR for adults).
The neuropsychological assessment will include:
An evaluation of the attentional treatment (Go-No / go and visual search) An evaluation of executive functions (TMT A and B) A brief evaluation of the IQ (items memory of figures, matrix and resemblance) An evaluation of the memory (Grober and Buschke) Tests include an adult and children versions that are validated. All studies will be conducted at the Nice University Hospital, Tours University Hospital and Toulouse University Hospital.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder (PTSD)
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
In remission phase of PTSD
Arm Type
Other
Arm Description
Patients having suffered from PTSD in the past and in remission od PTSD and their parents
Arm Title
Activ PTSD
Arm Type
Other
Arm Description
patients suffering from PTSD (Post-traumatic Stress Disorder) and their parents
Intervention Type
Behavioral
Intervention Name(s)
Neuropsychological assessment
Intervention Description
A clinical evaluation with Impact of Events Scale-Revised, Child Post-Traumatic Stress Reaction Index, State-Trait Anxiety Inventory for Children, Children Depression Inventory and Emotion, activity and sociability.
A neuropsychological assessment with a emotional Go-No/Go, a visual search task, the Trail Making Test, 3 items of the WISC III ( and the Grober and Buschke Test.
Primary Outcome Measure Information:
Title
Attentional score
Description
Go-No/Go and visual search tests
Time Frame
baseline at the first visit (T0), at 6 months, at 9 months
Secondary Outcome Measure Information:
Title
memory (Grober and Buschke)
Description
Grober and Buschke memory tests
Time Frame
baseline at the first visit (T0), at 6 months, at 9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
For children
Inclusion Criteria:
Children (9/18 years)
Patients who have lived a traumatic event (physical assault and road accident) and who have a PTSD.
French speaker.
Participants must sign the informed consent and they must be affiliated to the social insurance.
Exclusion Criteria
Children who have a neurological pathology.
Children who have brain damage or brain-injured
Subject having participated in a biomedical research in three months preceding the inclusion
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michel BENOIT, PhD
Email
benoit.m@chu-nice.fr
First Name & Middle Initial & Last Name or Official Title & Degree
morgane gindt
Email
morganegindt@yahoo.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel BENOIT, M.D.,PhD
Organizational Affiliation
Psychiatrie, Hôpital Pasteur, CHU de NICE
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wissam EL HAGE, M.D, PhD
Organizational Affiliation
Psychiatrie, CHU de TOURS
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Frédérique JOVER, M.D.
Organizational Affiliation
CAP, Hôpital St ROCH, CHU de NICE
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Florence ASKENAZY, M.D.
Organizational Affiliation
Fondation Lenval, NICE
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Philippe BIRMES, M.D.
Organizational Affiliation
Psychiatrie, CHU de TOULOUSE
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Virginie BUISSE, M.D.
Organizational Affiliation
CAP, Hôpital St Roch, CHU de NICE
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de NICE
City
Nice
ZIP/Postal Code
06000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michel BENOIT, M.D., PhD
Email
benoit.m@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
Michel BENOIT, M.D., PhD
First Name & Middle Initial & Last Name & Degree
Frédérique JOVER, M.D.
First Name & Middle Initial & Last Name & Degree
Virginie BUISSE, M.D, PhD
Facility Name
Fondation Lenval
City
Nice
ZIP/Postal Code
06000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
florence Askenazy, M.D.
Email
florence.askenazy@lenval.com
Facility Name
CHU de TOULOUSE
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe BIRMES, M.D.
Facility Name
CHU de TOURS
City
Tours
ZIP/Postal Code
37044
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wissam EL HAGE, M.D., PhD
12. IPD Sharing Statement
Learn more about this trial
Identification of Markers of Post-Traumatic Stress Disorder (PTSD) Relapse
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