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

Sponsor
Centre Hospitalier Universitaire de Nice (Other)
Overall Status
Unknown status
CT.gov ID
NCT01545505
Collaborator
(none)
120
4
2
21
30
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Neuropsychological assessment
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Early Diagnosis of Risk of Post-Traumatic Stress Disorder (PTSD) Relapse in Children and Their Families
Study Start Date :
Oct 1, 2012
Anticipated Primary Completion Date :
Oct 1, 2013
Anticipated Study Completion Date :
Jul 1, 2014

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Attentional score [baseline at the first visit (T0), at 6 months, at 9 months]

    Go-No/Go and visual search tests

Secondary Outcome Measures

  1. memory (Grober and Buschke) [baseline at the first visit (T0), at 6 months, at 9 months]

    Grober and Buschke memory tests

Eligibility Criteria

Criteria

Ages Eligible for Study:
9 Years to 18 Years
Sexes Eligible for Study:
All
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

Locations

Site City State Country Postal Code
1 CHU de NICE Nice France 06000
2 Fondation Lenval Nice France 06000
3 CHU de TOULOUSE Toulouse France 31059
4 CHU de TOURS Tours France 37044

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT01545505
Other Study ID Numbers:
  • 11-AOI-09
First Posted:
Mar 6, 2012
Last Update Posted:
Feb 21, 2013
Last Verified:
Feb 1, 2013

Study Results

No Results Posted as of Feb 21, 2013