Identification of Markers of Post-Traumatic Stress Disorder (PTSD) Relapse

Not Applicable

• Conditions: Post Traumatic Stress Disorder (PTSD)
• Interventions: Behavioral: Neuropsychological assessment

• Registration Number: NCT01545505
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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.

Study Timeline

• Study First Submitted: 2011-12-08
• Study First Submitted QC: 2012-03-01
• Study First Posted: 2012-03-06
• Study Start: 2012-10
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-20
• Last Update Posted: 2013-02-21
• Primary Completion: 2013-10
• Study Completion: 2014-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
In remission phase of PTSD	Neuropsychological assessment	Patients having suffered from PTSD in the past and in remission od PTSD and their parents
Activ PTSD	Neuropsychological assessment	patients suffering from PTSD (Post-traumatic Stress Disorder) and their parents

Primary Outcome Measures

Name	Time	Method
Attentional score	baseline at the first visit (T0), at 6 months, at 9 months	Go-No/Go and visual search tests

Secondary Outcome Measures

Name	Time	Method
memory (Grober and Buschke)	baseline at the first visit (T0), at 6 months, at 9 months	Grober and Buschke memory tests

Trial Locations

Locations (4)

CHU de TOURS; 🇫🇷 Tours, France

Fondation Lenval; 🇫🇷 Nice, France

CHU de TOULOUSE; 🇫🇷 Toulouse, France

CHU de NICE; 🇫🇷 Nice, France