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Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


NCT number NCT01545505
Study type Interventional
Source Centre Hospitalier Universitaire de Nice
Contact Michel BENOIT, PhD
Email benoit.m@chu-nice.fr
Status Recruiting
Phase N/A
Start date October 2012
Completion date July 2014

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