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

Early Diagnosis of Risk of Post-Traumatic Stress Disorder (PTSD) Relapse in Children and Their Families

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.

Study Overview

• Status: Unknown
• Conditions: Post Traumatic Stress Disorder (PTSD)
• Intervention / Treatment: Behavioral: Neuropsychological assessment

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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nice, France, 06000
    • Recruiting
    • CHU de Nice
    • Contact: Michel BENOIT, M.D., PhD; Email: 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
  • Nice, France, 06000
    • Recruiting
    • Fondation Lenval
    • Contact: florence Askenazy, M.D.; Email: florence.askenazy@lenval.com
  • Toulouse, France, 31059
    • Not yet recruiting
    • CHU de Toulouse
    • Principal Investigator: Philippe BIRMES, M.D.
  • Tours, France, 37044
    • Recruiting
    • CHU de Tours
    • Principal Investigator: Wissam EL HAGE, M.D., PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attentional score	Go-No/Go and visual search tests	baseline at the first visit (T0), at 6 months, at 9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
memory (Grober and Buschke)	Grober and Buschke memory tests	baseline at the first visit (T0), at 6 months, at 9 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: 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

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Anticipated): October 1, 2013
• Study Completion (Anticipated): July 1, 2014

Study Registration Dates

• First Submitted: December 8, 2011
• First Submitted That Met QC Criteria: March 1, 2012
• First Posted (Estimate): March 6, 2012

Study Record Updates

• Last Update Posted (Estimate): February 21, 2013
• Last Update Submitted That Met QC Criteria: February 20, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 11-AOI-09