Identification of Markers of Post-Traumatic Stress Disorder (PTSD) Relapse
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Post Traumatic Stress Disorder (PTSD) |
Behavioral: Neuropsychological assessment |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Early Diagnosis of Risk of Post-Traumatic Stress Disorder (PTSD) Relapse in Children and Their Families |
- Attentional score [ Time Frame: baseline at the first visit (T0), at 6 months, at 9 months ] [ Designated as safety issue: No ]Go-No/Go and visual search tests
- memory (Grober and Buschke) [ Time Frame: baseline at the first visit (T0), at 6 months, at 9 months ] [ Designated as safety issue: No ]Grober and Buschke memory tests
| Estimated Enrollment: | 120 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
In remission phase of PTSD
Patients having suffered from PTSD in the past and in remission od PTSD and their parents
|
Behavioral: Neuropsychological assessment
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. |
|
Activ PTSD
patients suffering from PTSD (Post-traumatic Stress Disorder) and their parents
|
Behavioral: Neuropsychological assessment
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. |
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.
Eligibility| Ages Eligible for Study: | 9 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Michel BENOIT, PhD | benoit.m@chu-nice.fr | |
| Contact: morgane gindt | morganegindt@yahoo.fr |
| France | |
| CHU de NICE | Recruiting |
| Nice, France, 06000 | |
| Contact: Michel BENOIT, M.D., PhD benoit.m@chu-nice.fr | |
| Principal Investigator: Michel BENOIT, M.D., PhD | |
| Principal Investigator: Frédérique JOVER, M.D. | |
| Sub-Investigator: Virginie BUISSE, M.D, PhD | |
| Fondation Lenval | Recruiting |
| Nice, France, 06000 | |
| Contact: florence Askenazy, M.D. florence.askenazy@lenval.com | |
| CHU de TOULOUSE | Not yet recruiting |
| Toulouse, France, 31059 | |
| Principal Investigator: Philippe BIRMES, M.D. | |
| CHU de TOURS | Recruiting |
| Tours, France, 37044 | |
| Principal Investigator: Wissam EL HAGE, M.D., PhD | |
| Principal Investigator: | Michel BENOIT, M.D.,PhD | Psychiatrie, Hôpital Pasteur, CHU de NICE |
| Principal Investigator: | Wissam EL HAGE, M.D, PhD | Psychiatrie, CHU de TOURS |
| Principal Investigator: | Frédérique JOVER, M.D. | CAP, Hôpital St ROCH, CHU de NICE |
| Principal Investigator: | Florence ASKENAZY, M.D. | Fondation Lenval, NICE |
| Principal Investigator: | Philippe BIRMES, M.D. | Psychiatrie, CHU de TOULOUSE |
| Principal Investigator: | Virginie BUISSE, M.D. | CAP, Hôpital St Roch, CHU de NICE |
More Information
No publications provided
| Responsible Party: | Centre Hospitalier Universitaire de Nice |
| ClinicalTrials.gov Identifier: | NCT01545505 History of Changes |
| Other Study ID Numbers: | 11-AOI-09 |
| Study First Received: | December 8, 2011 |
| Last Updated: | February 20, 2013 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) France: Institutional Ethical Committee |
Additional relevant MeSH terms:
|
Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Anxiety Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 19, 2013